Bacteria in Atherosclerotic Plaques and Adverse Events
Conditions: Carotid Artery Stenosis, Cerebral Infarction, Diabetes, Bacteria, Bacterial Colonization, Hypertension, Carotid Plaque, Intracellular Bacteria, Atherosclerosis of Artery, Bacteria in Plaques
Sponsor: Tang-Du Hospital

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Bacteria in Atherosclerotic plaques and adverse events
Study Protocol
ClinicalTrials.gov ID：NCT06935279
Department of Neurosurgery
Tangdu Hospital
Date: 01 Jan 2024

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Bacteria in Atherosclerotic plaques and adverse events
1.
Integrity Statement
All physicians and staff members involved in the study solemnly declare:
The application materials submitted herein are true and valid. All physicians and staff members involved in
the study guarantee that all procedures were strictly conducted in accordance with the trial protocol, ensuring the
authenticity of all data recorded. All physicians and staff members involved in the study have no conflicts of
interest of any kind, whether personal, corporate, commercial, or related to scientific research.
2.
Research Background
2.1 The Harmful Effects of Bacteria (Especially Intracellular Bacteria) in Atherosclerotic Plaques.
Atherosclerosis is not merely a disease of lipid deposition, and bacteria within plaques are not harmless
bystanders. Instead, they actively participate in and drive disease progression through multiple mechanisms.
Bacteria (especially intracellular bacteria) serve as significant destabilizing factors that promote inflammation and
plaque formation. Their detrimental effects span the entire process of plaque formation, progression, and rupture.
Their core hazards can be summarized as follows:
2.1.1 Trigger and continuously amplify the local inflammatory response in the plaque.
Intracellular bacteria (such as Chlamydia pneumoniae, Porphyromonas gingivalis, Helicobacter pylori, etc.)
can invade and colonize core cells within plaques, including vascular endothelial cells, macrophages, and smooth
muscle cells. They evade host immune clearance by continuously releasing lipopolysaccharides (LPS),
lipoproteins, and virulence factors. This activates inflammatory pathways like NF-κB and MAPK, driving cells to
secrete pro-inflammatory mediators such as TNF-α, IL-6, and IL-1β.
2.1.2 Disrupting plaque structural stability.
Degradation of the extracellular matrix: Intracellular bacteria induce macrophages and smooth muscle cells
to secrete matrix metalloproteinases (MMPs, such as MMP-2 and MMP-9), which degrade structural components
like collagen in the fibrous cap of atherosclerotic plaques. This leads to thinning of the fibrous cap and increased
fragility.
Promoting foam cell formation: Intracellular bacteria disrupt macrophage lipid metabolism, inhibit
cholesterol reverse transport, accelerate foam cell accumulation, and enlarge the plaque core lipid pool, leading to
the formation of vulnerable plaques (thin fibrous caps over large lipid cores).
Induction of apoptosis/pyroptosis: Intracellular bacterial infection can trigger apoptosis or pyroptosis in host
cells, leading to reduced extracellular matrix synthesis within plaques and massive accumulation of inflammatory
cells, which further compromises the structural stability of the plaque.
2.1.3 Induce intraluminal thrombosis.
Intracellular
bacteria
can
directly
activate
the
coagulation
system:
On
one
hand,
their
surface
pathogen-associated molecular patterns (PAMPs) activate platelets, promoting platelet adhesion and aggregation;
On the other hand, they can infect cells and induce the release of inflammatory mediators (such as tissue factor),
initiating the extrinsic coagulation pathway. This leads to microthrombus formation within plaques, exacerbating
plaque stenosis while also laying the groundwork for subsequent acute thrombotic events caused by plaque

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rupture.
2.1.4 The Interplay Between Systemic Inflammation and Metabolic Dysregulation.
Bacteria (including intracellular bacteria) can spread through the blood and lymphatic circulation, triggering
low-grade systemic inflammation that disrupts insulin sensitivity and lipid metabolism, thereby indirectly
accelerating the progression of atherosclerosis. Concurrently, the systemic inflammatory state further diminishes
the vascular endothelium's resistance to injury, forming a chain reaction of "local infection - systemic
inflammation - vascular damage".
2.2 Association Between Bacteria-Related Atherosclerotic Plaques and Stroke.
One of the core pathological mechanisms underlying stroke (particularly ischemic stroke, accounting for
approximately 70% of cases) involves the formation of atherosclerotic plaques in locations such as the carotid
arteries and intracranial arteries. These plaques lead to vascular stenosis, plaque rupture, or thrombus detachment.
Bacteria, especially intracellular bacteria, directly or indirectly exacerbate the risk and severity of stroke through
the following mechanisms:
2.2.1 Accelerated arterial stenosis leads to insufficient cerebral perfusion.
Chronic inflammation driven by bacteria, particularly intracellular bacteria, causes persistent damage to
cerebral vascular endothelium, accelerating plaque formation and progression. This leads to luminal narrowing in
critical vessels such as the carotid artery and middle cerebral artery: When stenosis reaches ≥70%, cerebral
blood flow significantly decreases, placing brain tissue in a state of chronic ischemia and hypoxia, which can
trigger ischemic stroke. If combined with factors such as hypotension or increased blood viscosity, the risk of
ischemia further escalates.
2.2.2 Induce vulnerable plaque rupture, leading to acute thrombotic stroke.
Intracellular bacteria destabilize the fibrous cap of atherosclerotic plaques, making them more prone to
rupture. The exposed lipid core and collagen, which are procoagulant substances, can rapidly activate the
coagulation system, forming acute thrombi that completely occlude cerebral vessels and trigger acute ischemic
stroke (such as cerebral infarction). Even if the plaque does not rupture completely, microemboli (containing
bacteria, platelets, and fibrin) detaching from its surface can travel through the bloodstream and block small
cerebral arteries, leading to lacunar infarction.
2.2.3 Exacerbate brain tissue damage following stroke.
Following a stroke, systemic and local inflammatory responses induced by bacteria (particularly intracellular
bacteria) spread to brain tissue: On one hand, pro-inflammatory cytokines breach the blood-brain barrier,
exacerbating ischemic-reperfusion injury and enlarging the infarct area; On the other hand, intracellular bacteria
may directly invade ischemic brain tissue (due to blood-brain barrier disruption), triggering intracranial infections
such as encephalitis or meningitis, which significantly increase the disability and mortality rates associated with
stroke.
2.2.4 Targeted harm by specific intracellular bacteria
Chlamydia pneumoniae is the most common intracellular bacterium in cerebral atherosclerotic plaques. It
can directly invade intracranial vascular endothelial cells, inducing local inflammation and plaque formation.
Multiple cohort studies have confirmed that patients with positive serum Chlamydia pneumoniae show a 2- to

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3-fold increased risk of ischemic stroke.
Porphyromonas gingivalis originates from periodontal infections and can colonize carotid plaques via the
bloodstream. The gingiphin it secretes degrades vascular endothelial adhesion molecules, accelerating plaque
instability and increasing the risk of recurrent stroke.
Helicobacter pylori can indirectly promote cerebral vascular plaque progression by inducing systemic
inflammation and disrupting lipid metabolism (e.g., elevating LDL-C). It is significantly associated with the onset
of ischemic stroke in middle-aged and young patients.
Bacteria, especially intracellular bacteria, act as key drivers of atherosclerotic plaque progression and
instability through a cascade reaction involving "colonization - pro-inflammatory response - disruption of plaque
structure - activation of coagulation".
Narrowing, rupture, or microembolism of atherosclerotic plaques in cerebral vessels (carotid arteries,
intracranial arteries) are core triggers of ischemic stroke. Intracellular bacteria not only elevate stroke risk but also
exacerbate disease severity and recurrence risk. This association also offers potential directions for stroke
prevention, such as targeted antimicrobial therapy and management of chronic infections.
This prospective cohort study can be used to assess whether the research question truly exists in clinical
practice and to analyze its risk factors. This project aims to collect patient demographics and research data through
an Electronic Data Capture (EDC) system to establish a postoperative registry database. To identify suitable
carotid plaques for carotid endarterectomy, healthcare providers will strictly adhere to clinical pathway protocols
for diagnosis and treatment, implementing standardized management to effectively alleviate patient symptoms and
reduce physical and psychological distress. Simultaneously, by analyzing bacterial populations within carotid
plaques, identifying intracellular bacterial species, and integrating clinical data for risk factor analysis, we aim to
distinguish bacterial types associated with adverse outcomes (cerebral infarction, carotid restenosis, mortality).
This approach will enhance the clinical efficacy of carotid stenosis treatment, offering practical clinical value in
ultimately preventing cerebral infarction and conserving healthcare resources.
3. Research Objectives
3.1 Primary research objectives
This project aims to establish a registry center for patients and specimen banks following carotid
endarterectomy. Conduct plaque detection and analysis in patients undergoing carotid endarterectomy over a
defined period, perform follow-up monitoring, track blood laboratory indicators, execute data cleansing, analyze
bacterial species within plaques, identify bacteria associated with postoperative adverse events, and derive
corresponding expected conclusions.
3.2 Secondary research objectives
a. Assess bacterial species within carotid plaques; identify bacterial differences and perform functional
analysis in atherosclerotic plaques across distinct disease types.
b. Detect bacterial species within plaques associated with adverse postoperative events (cerebral infarction,
carotid restenosis, death), identify risk bacteria linked to poor outcomes, and perform functional analysis.
c. Cleanse clinical data, analyze the correlation between postoperative adverse events and bacteria within

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high-risk plaques, and adjust for confounding factors including age, gender, body mass index, total cholesterol,
high-density lipoprotein, low-density lipoprotein cholesterol, triglycerides, creatinine, diabetes, and hypertension
to enhance the reliability of research findings.
4. Overall Design
This study is a prospective, multicenter cohort study in western China.
This registration study was primarily conducted in the Department of Neurosurgery at Tangdu Hospital, with
participation from the Departments of Neurosurgery at the Second Affiliated Hospital of Xi'an Medical University,
Hanzhong Central Hospital, Hanzhong 3201 Hospital, Baoji People's Hospital, and Pucheng County People's
Hospital. The study population consisted of patients aged 18 to 90 years who underwent CEA surgery. Patients
who meet all inclusion criteria and none of the exclusion criteria may be considered for enrollment after
demonstrating informed consent to participate in this registry study and agreeing to sign the informed consent
form.
All patients participating in this study underwent a comprehensive standardized evaluation conducted by a
multidisciplinary team comprising neurologists, neurosurgeons, hematologists, endocrinologists, and other
practitioners. The assessment included examinations of neurological, neuropsychological, and psychiatric
conditions, endocrine disorders, and hematological parameters. Bacterial species identification was performed
using 16SrDNA sequencing, with further validation through transmission electron microscopy.
Selected patients will undergo routine surgical treatment and attend follow-up appointments as recommended
by their physicians, while accurately recording relevant data generated during clinical practice. Data information
from patients' clinical visits will be documented, including preoperative assessment, preoperative care, operating
room care, anesthesia management, intraoperative procedures, postoperative medical management, postoperative
nursing care, and follow-up information.
4.1 Inclusion Criteria
Patients clinically diagnosed with moderate to severe carotid artery stenosis
Age 18 ≤age ≤90
Patients undergoing carotid endarterectomy (CEA)
Preoperative MRS score for stroke patients: 0-2
Preoperative NIHSS score for stroke patients: 0–20
Patient's Glasgow Coma Scale (GCS) score upon admission: 8-15 points
No fever or evidence of infection at admission
Informed consent signed by the subject or their legal representative
Good compliance with follow-up visits
4.2 Exclusion Criteria
Brain tumor (presence of mass effect)
Patient's Glasgow Coma Scale (GCS) score < 8
Refractory hypertension unresponsive to medication (defined as sustained systolic blood pressure >185
mmHg or diastolic blood pressure >110 mmHg)

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History of severe infection within the past three months
Severe or acute heart failure
Acute myocardial infarction or severe arrhythmia
Undergone major organ surgery or biopsy within the past month
Any active bleeding or recent bleeding (gastrointestinal, urinary tract, etc.) within the past month
Currently undergoing hemodialysis or peritoneal dialysis; known severe renal impairment (glomerular
filtration rate < 220 mmol/L (2.5 mg/dL))
Concurrent malignant tumors, severe cardiopulmonary disease, or other conditions rendering the patient
unable to tolerate surgery
Has participated in other interventional clinical studies that may influence the outcome assessment
Severe liver function abnormalities
Other circumstances deemed by the investigator to make participation in this study inappropriate or pose
significant risk to the patient (e.g., inability to understand and/or comply with study procedures and/or follow-up
due to psychiatric, cognitive, or emotional disorders)
Currently receiving immunosuppressive agents or undergoing immunotherapy
Severe chest or abdominal trauma requiring surgery、Severe Traumatic Brain Injury
Infectious Diseases such as Syphilis, AIDS, Hepatitis, and Tuberculosis
Patients with both hypertension and diabetes
5. Research Design Plan
5.1 Research Methodology: This study is a prospective, multicenter cohort study.
This registry study is primarily conducted in the Department of Neurosurgery at Tangdu Hospital. The target
population consists of adults aged 18 to 90 years who present to the neurosurgery department and require carotid
endarterectomy. Patients meeting all inclusion criteria and none of the exclusion criteria may be considered for
enrollment after demonstrating informed consent to participate in this registry study and agreeing to sign the
informed consent form.
5.2 All patients participating in this study underwent a comprehensive standardized evaluation conducted by
a multidisciplinary team comprising neurologists, neurosurgeons, hematologists, endocrinologists, and other
practitioners. The evaluation included examinations of neurological status, neuropsychological and psychiatric
conditions, endocrine disorders, and hematological parameters.
5.3 Patients enrolled in the study will undergo routine surgical treatment and attend follow-up visits as
recommended by their physicians, while accurately recording all relevant data generated during clinical practice.
Data information from patients' clinical visits will be documented, including preoperative assessment,
preoperative care, operating room care, anesthesia management, intraoperative procedures, postoperative medical
management, postoperative nursing care, and follow-up information.
5.4 Major Research Projects and Content
5.4.1 Assess the types of bacteria present in carotid plaques to preliminarily identify the relationship between
bacteria and plaque associated with different disease types;
5.4.2 Detect bacteria within plaques associated with adverse postoperative outcomes (cerebral infarction,

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carotid restenosis, death), identify risk bacteria linked to poor outcomes, and conduct preliminary functional
analysis of these bacteria.
5.4.3 Analyze clinical data to investigate the correlation between postoperative adverse events and bacteria
within high-risk plaques, while adjusting for confounding factors such as age, gender, body mass index, total
cholesterol, high-density lipoprotein, low-density lipoprotein, cholesterol, triglycerides, creatinine, diabetes, and
hypertension to enhance the reliability of the study findings.
5.5 Research Flowchart
6. Key Statistical Indicators
This study will collect all data during the inpatient period (baseline phase) for patients requiring surgical
intervention, as well as follow-up data after discharge. Data points to be collected for patients with carotid
stenosis include:
6.1 Baseline Information Collection
Admission Assessment and Enrollment: Demographic Data: Date of Birth, Gender, Educational Attainment,
Ethnicity, Occupation Type, Health Insurance Type, Nature of Employment;
Carotid Artery Stenosis Assessment:
Document the degree of carotid artery stenosis in the patient;
Preoperative Preparation: Past medical history and current medical history, including hypertension, diabetes,
hyperlipidemia, cerebral infarction, renal disease, history of cardiovascular and cerebrovascular diseases, and
other chronic conditions. Whether antibiotics were administered during surgery, types and reasons for previous
surgeries, surgical sites, and use of analgesics postoperatively. Additionally, collect history of previous drug
therapy, including medications used to treat and control related comorbidities.
Physical Examination: Nutritional Assessment Status: Including height, weight, body fat percentage, muscle
mass, grip strength; heart rate, respiratory rate, body temperature, systolic/diastolic blood pressure; Assessment of
Positive Findings in Neurological Examination: Optic nerve damage, oculomotor nerve damage, limb paralysis,

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neck resistance;
Comprehensive Patient Assessment and Optimization: Whether relevant assessments and optimization
measures have been conducted, including water and electrolyte balance, complete blood count, biochemical tests,
coagulation function tests, and status of vital organ function (lungs, heart, kidneys, liver).
Scale Assessment: Evaluate patients' functional status preoperatively, intraoperatively, and postoperatively
using the American Society of Anesthesiologists (ASA) risk classification, long-term quality of life assessment,
and the General Hospital Anxiety/Depression Scale (GHAS), Depression Scale, NRS2002 score, VTE Caprini
Risk Assessment Scale, Autar DVT Risk Scale, Operating Room Pressure Ulcer Risk Assessment (Braden),
PONV Risk Score for preventing postoperative nausea and vomiting, and Visual Analogue Scale (VAS) for nausea
and vomiting.
Preoperative Communication: Patients receive counseling and guidance regarding the surgical and anesthetic
procedures prior to surgery. Whether the patient received counseling and guidance from the surgeon,
anesthesiologist, and nurse/head nurse regarding the surgical and anesthetic procedures. Record the duration of the
communication visit (in minutes).
Antihypertensive drug therapy: Initiate with low doses, prioritize long-acting formulations, employ
combination therapy, and tailor treatment to individual needs. Common antihypertensive agents include five
classes: beta-blockers, calcium channel blockers, angiotensin-converting enzyme inhibitors, angiotensin receptor
blockers, and diuretics, as well as fixed-dose combination formulations comprising these drugs. In the absence of
concomitant vascular stenosis, post-CEA surgery blood pressure control below 140/90 mmHg is recommended.
Diabetes Medication Management: Patients with carotid artery stenosis and concomitant diabetes must
intensify dietary control. Target blood glucose levels: non-fasting glucose below 11.1 mmol/L, with HbA1c <7%
during treatment.
Lipid-lowering medication: Statin therapy is recommended for patients with carotid stenosis. For those at
high risk of stroke, low-density lipoprotein (LDL) levels should be controlled below 100 mg/dL. Niacin or
fibrate-based lipid-lowering agents may be considered for patients with hypertriglyceridemia.
Smoking Cessation: Quitting smoking is a critical preventive and therapeutic measure for carotid stenosis.
Smokers should be strictly required and encouraged to quit, and exposure to secondhand smoke should be
avoided.
Antiplatelet and Anticoagulant Therapy: Recommended antiplatelet agents include aspirin and clopidogrel.
Low-dose aspirin (75–150 mg/day) achieves equivalent efficacy to high-dose regimens. Heparin therapy should
be administered prior to carotid artery occlusion during surgery.
Hyperhomocysteinemia management: Elevated homocysteine levels increase stroke risk. Patients with
carotid
stenosis
and
concomitant
hyperhomocysteinemia
should
receive
B-complex
vitamin
therapy
preoperatively.
6.2 Preoperative Evaluation
Indications for Surgery: Absolute Indications: Symptomatic carotid stenosis with noninvasive testing
showing ≥70% stenosis or angiography revealing ≥50% stenosis. Relative Indications: (1) Asymptomatic
carotid stenosis with noninvasive testing showing ≥70% stenosis or angiography revealing ≥60% stenosis; (2)
Asymptomatic carotid stenosis with noninvasive testing showing <70% stenosis, but angiography or other studies

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indicating unstable stenotic lesions; (3) Symptomatic carotid stenosis with noninvasive testing showing 50%–69%
stenosis.
Perioperative Pharmacotherapy: All enrolled patients are recommended to receive single antiplatelet therapy
with aspirin (100 mg/day) or clopidogrel (75 mg/day) preoperatively to reduce thrombosis risk. High-dose
antiplatelet agents are not recommended. Intraoperatively, administer heparin anticoagulation 5 minutes prior to
arterial occlusion to prolong activated clotting time (ACT) or activated partial thromboplastin time (aPTT) by at
least 1.5-fold. Postoperatively, continue single antiplatelet therapy for at least 4 weeks.
Timing of Surgery: (1) For acute ischemic stroke, surgery is relatively safe after 6 weeks post-onset.
However, for patients with recent symptom onset and imaging evidence of unstable plaques, early intervention
should be pursued whenever possible, ideally within 2 weeks. (2) For patients with TIA or minor stroke,
intervention may be performed within 2 weeks of the event if there are no contraindications to early
revascularization. (3) In cases of bilateral lesions, the interval between bilateral surgeries may range from 2 to 4
weeks based on clinical circumstances, with priority given to the symptomatic side and/or the side with more
severe stenosis.
Choice of surgical approach: Includes two types: the eversion endometrial resection and the traditional
longitudinal incision endometrial resection.
Complications and Prevention: (1) Stroke and Mortality. Stroke is associated with ischemia caused by plaque
detachment and occlusion. Strict individualized perioperative blood pressure management is generally required.
Intraoperative close monitoring is essential to reduce strokes due to hemodynamic disturbances. Intraoperative
cerebral oxygen saturation monitoring, TCD monitoring, and intraoperative electrophysiological monitoring
should be performed. Intraoperative stump pressure should be monitored. Perform gentle intraoperative
maneuvers and selectively use bypass tubes. Anticoagulant therapy may be administered based on specific
circumstances. Perioperative measures such as antiplatelet agents should be employed to reduce embolic risk. (2)
Cranial Nerve Injury. The most commonly affected nerves include the hypoglossal, vagus, and accessory nerves,
with injuries typically being transient. These may be related to surgical traction and edema. Intraoperative
maneuvers should be gentle, with precise identification of delicate cervical anatomical structures to avoid nerve
injury from surgical traction. Cutaneous nerve injury is generally difficult to prevent. Postoperative numbness
around the jaw or behind the ear may occur. For all enrolled surgical patients, the length of the cervical surgical
incision should be controlled at approximately 3-5 cm to minimize cutaneous nerve injury caused by excessive
incision length. (3) Hyperperfusion Syndrome. Primary clinical manifestations include severe localized headache,
localized and/or generalized convulsions, and cerebral hemorrhage in the ipsilateral hemisphere. Prophylactic
administration of antihypertensive and dehydrating agents (e.g., mannitol) during carotid artery reperfusion and
postoperatively may mitigate cerebral edema. (4) Neck hematoma and laryngeal edema. The former is often
associated with incomplete local hemostasis or inadequate arterial suturing, while the latter may relate to
anesthesia intubation. Closely monitor oxygen saturation, enhance suturing techniques, and meticulously control
bleeding—particularly preventing damage to extensive veins and lymph nodes during dissection. Once hematoma
or laryngeal edema occurs, prevent asphyxia. (5) Thrombosis and restenosis. Contributing factors include
intraoperative mishandling, inadequate postoperative medication, and excessive smooth muscle or intimal
hyperplasia. Monitor for heparin resistance. Administer perioperative oral antiplatelet agents and intimal

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hyperplasia inhibitors; consider traditional Chinese medicine when indicated.
Data Collection and Definition: Patient demographic and clinical data, including age, gender, smoking and
drinking history, past medical history, echocardiography results, angiography assessment findings, and
medications used at discharge, were collected from electronic medical record systems by physicians unaware of
the study's purpose. All participants provided fasting (>8 h) peripheral venous blood for measurement of white
blood cell count (WCC), platelet count (PLT), hemoglobin (HGB), fasting blood glucose (FBG), total bilirubin
(TB), direct bilirubin (DBIL), indirect bilirubin (IBIL), creatine kinase (CK), creatine kinase isoenzyme (CK-MB),
creatinine, uric acid (UA), high-sensitivity C-reactive protein (Hs-CRP), and lipid profile (total cholesterol (CHO),
TG, LDL, high-density lipoprotein (HDL), lipoprotein a (Lpa)).
6.3 Intraoperative Management
Operating Room Nursing: Operating room parameters (temperature, humidity), entry/exit times, duration of
surgery, level of consciousness upon entry, psychological status, catheterization method, antibiotic prophylaxis
and allergic reactions, infusion reactions, hypothermia prevention status confirmation (including body temperature,
use of warming blankets, infusion of fluids, use of irrigation solutions), VTE (Venous Thromboembolism)
prevention and pressure ulcer prevention (including intraoperative positioning, care of pressure points, and care
frequency);
Pre-anesthesia management: Including anesthesia time, anesthesia method, monitoring parameters
(anesthesia depth, cardiac output, neuromuscular blockade, temperature, arterial blood gas, etc.), presence of
preoperative local anesthesia at incision site, presence of postoperative local anesthesia at incision site,
intraoperative circulatory status, fluid output, fluid replacement volume, blood transfusion volume, transfusion
reactions, level of consciousness grading, Steward recovery score, and extubation status prior to leaving the
operating room. Also includes pre-anesthesia medication administration, recording brand name, generic name,
dosage, frequency, and duration; Anesthetic induction: Record patient cardiopulmonary and renal function data.
Routinely monitor electrocardiogram (ECG), invasive mean arterial pressure (IMAP), oxyhemoglobin saturation
(SpO₂), partial pressure of carbon dioxide in end-tidal gas (PetCO₂), Bispectral Index (BIS). Document anesthetic
induction medications, including brand name, generic name, dosage, frequency, and duration.
Anesthesia Maintenance Protocol: Record anesthesia maintenance protocol data, including drug brand names,
generic names, dosages, frequency, and duration;
Blood Pressure Management: Document whether the patient experienced blood pressure fluctuations during
surgery, including deviations exceeding
± 20% from baseline levels and SBP
≥
180 mmHg. Record
corresponding blood pressure management medications, including brand names, generic names, dosages,
frequency, and duration;
Fluid Therapy: Document fluid administration methods during surgery, including vasoactive agents, normal
saline, sodium acetate Ringer's solution, and Ringer's lactate solution. Record events where plasma osmolarity or
stroke volume variation (SVV) monitoring exceeded ≥13%.
Ventilation Strategy: Document data points related to the ventilation strategy employed, including associated
events.
Temperature Monitoring and Warming: Prevent hypothermia during surgery. Document episodes of core
temperature ≤36°C.
Thromboprophylaxis:
Include
thromboprophylactic
measures,
medications,
or
adjunctive
products.

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Document occurrence of postoperative venous thromboembolic events.
CEA Surgical Procedure Flowchart: All surgeries in this study were performed by Associate Professor Liu
Bei as the primary surgeon. Intraoperative cerebral oxygenation monitoring, electrophysiological monitoring, and
transcranial Doppler ultrasound monitoring were performed. The patient was positioned supine with the head
hyperextended,
tilted
backward,
and
deviated
toward
the
contralateral
side.
Marked
an
anterior
sternocleidomastoid muscle incision approximately 3-5 cm in length. Following routine disinfection and draping,
sequentially incised the skin, subcutaneous tissue, and platysma muscle. Make a sharp dissection along the
anterior border of the sternocleidomastoid muscle to deeper structures, dissecting and exposing the carotid sheath.
Following exposure of the carotid sheath, administer heparin at a dose of 83 IU/kg. Utilized specialized CEA
instruments to dissect the carotid sheath, progressively exposing the common carotid artery (CCA), internal
carotid artery (ICA), and external carotid artery (ECA). Administer lidocaine block at the carotid sinus location at
the bifurcation site. Sequentially occlude the superior thyroid artery, internal carotid artery, external carotid artery,
and common carotid artery, controlling arterial occlusion time between 10-20 minutes. Under microscopic
visualization, make a longitudinal incision in the artery. Carefully dissect and remove the plaque. Irrigate
repeatedly with heparinized saline. Microscopically remove any residual plaque. After confirming a smooth
intima, perform continuous suturing from the distal ICA toward the CCA at approximately 1 mm intervals.
Following the procedure, perform intraoperative fluorescein angiography to assess vascular patency.
Schematic Diagram of Intraoperative Incision:
Sample Processing and Storage: After plaque sampling, immediately rinse with saline solution on the
operating table to remove blood stains. Rapidly freeze in liquid nitrogen, then transfer to pre-chilled
cryopreservation tubes. Seal with a sealing film and immediately store at -80°C.
6.4 Postoperative Management
Secondary prevention strategies for postoperative patients should be implemented according to current
guidelines. Maintain activated clotting time (>24 hours) with unfractionated heparin (83 IU/kg, titrated as needed)
postoperatively.
Postoperative Diet: Document time to clear liquid intake, time to clear liquid diet, and time to regular diet
following surgery.
Pain Management: Record location, nature, intensity score, duration, analgesic usage, and use of analgesic
pumps. Conduct daily pain assessments throughout hospitalization until discharge, documenting the highest pain

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score recorded that day.
Respiratory Management: Document tracheal intubation status and extubation time; record postoperative use
of intravenous (pre-ambulation) and nebulized medications;
Gastrointestinal Management: Includes mucosal protection measures and mucosal lesions;
Imaging Follow-up: Document results of follow-up imaging studies, including head/chest CT, head MRI,
head and neck CTA;
Other Postoperative Management Principles: Including parenteral nutrition, time of postoperative fluid
cessation, fluid reactions, nutritional assessment at discharge, mental status at discharge, KPS score at discharge,
and other scale assessments; inpatient parameters (including hospitalization costs, total hospitalization days,
postoperative hospitalization days). If secondary surgery occurs during hospitalization, corresponding records
must be made;
Satisfaction: Assess patient satisfaction with clinical services at discharge;
Patch collection and preservation: Atherosclerotic plaque samples excised from the carotid bifurcation during
endarterectomy are collected in Eppendorf tubes, rapidly frozen in liquid nitrogen, stored at -80°C, or fixed in
2.5% glutaraldehyde electron microscopy fixative for subsequent analysis.
6.5 Pharmacotherapy
Patients undergoing perioperative medication therapy, including traditional Chinese medicine or adjunctive
devices, require documentation of the following: generic name, brand name, dosage and administration, frequency
of administration, duration of use, purpose of medication, drug cost, and reason for medication change. As
surgical management is process-oriented, medication therapy should be categorized according to clinical practice
(admission, preoperative, intraoperative, postoperative, discharge) and summarized in a master table. Reasons for
medication adjustments must be recorded. Poor efficacy: Determined based on surgical outcome, e.g., non-healing
incision. Significant medical events/adverse events/adverse reactions: Gastrointestinal reactions; edema; weight
gain;
changes
in
liver/kidney
function;
allergies;
other
discomforts.
Researcher-initiated
adjustments,
patient-initiated adjustments (specific reasons).
6.6 Adverse Event (AE)/Serious Adverse Event (SAE):
This project reports adverse events/serious adverse events as specified in the protocol. All adverse reaction
events must be collected and reported, regardless of whether they are related to these products. Since surgical
management is process-based, AEs/SAEs are categorized and summarized by clinical pathway in the master table.
6.7 Follow-up Period Data Collection
Follow-up: Post-discharge follow-up schedule, conducted as outpatient visits.
Follow-up content includes: General patient status, including physical examination and necessary laboratory
tests, required imaging studies, and relevant scale assessments, including neuropsychiatric scoring. If the patient
undergoes secondary surgery or is readmitted during follow-up, corresponding records must be documented. If
additional laboratory tests are performed during follow-up, copies of the original reports must be filed in the
medical record. The patient's current medical history, hospitalization details, medication status — particularly
reasons for medication changes, dosages, and efficacy—must be documented. Investigators must enter laboratory
test data into the eCRF (electronic Case Report Form) and retain the original test reports. Investigators must also
provide assessments of laboratory test results as normal/abnormal and reference ranges.

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7. Research time frame
This study will be conducted in the following two phases:
1) Study Preparation: This phase includes developing materials (CRF, EDC), Informed Consent Forms (ICF),
selecting and evaluating study sites, obtaining ethics committee approval, developing the EDC system, and
initiating the protocol and study sites. This phase is expected to take 2 months.
2) Patient enrollment, testing, follow-up, and data analysis completion: Estimated at 16 months.
The total duration of this study, from initiation to completion of the final study report, is projected to be 18
months.

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Statistical Analysis Plan (SAP)
Study approval and patient consent
The study protocol was approved by the Institutional Review Committee of Tangdu Hospital
(approval no. 202501-03) and conducted in accordance with the ethical principles for medical
research involving human subjects described in the Declaration of Helsinki. All patients were
informed of the trial objectives and methodology upon recruitment and informed consent was
obtained prior to inclusion in this study.
Study design
This multicenter, cohort clinical study was conducted across six hospitals in China (Supplementary
Protocol) from January 2024 to July 2025. The protocol in the supplementary documents provides
detailed information on the rationale, design, and methodology of the study. Of 353 potential
participants, 55 refused to undergo screening and 98 did not meet the inclusion criteria, resulting in
the collection of plaques from 200 patients who met the inclusion criteria.
Plaque samples were
collected
via carotid
endarterectomy, immediately
rinsed
with
physiological saline to remove residual blood, and then placed in cryovials, which were sealed with
parafilm and stored at -80°C for subsequent analysis. Bacteria in the plaque samples were identified
via 5R 16S rRNA gene sequencing and validated by transmission electron microscopy
(Supplementary Material). All analyses were conducted in a blinded manner.
Study cohort
The study cohort included 200 patients (age, 18–90 years) who were clinically diagnosed with
moderate to severe carotid stenosis, met the inclusion criteria, and scheduled to undergo carotid
endarterectomy. The study cohort also included patients with a history of stroke, who were required
to have a preoperative modified Rankin Scale score of 0–2 and preoperative National Institutes of
Health Stroke Scale score of 0–20. The exclusion criteria included any history of a brain tumor,
refractory HTN, severe or acute heart failure, acute myocardial infarction or severe arrhythmia,
severe liver function abnormalities, or known severe renal insufficiency. Patients with a history of
severe infection (within the past 3 months), recent solid organ surgery, biopsy, or any active or
recent bleeding (e.g., gastrointestinal, urinary), as well as those with both HTN and DM, were also
excluded. Details of the inclusion and exclusion criteria are provided in the supplementary protocol.
Randomization and masking
Baseline clinical examinations were conducted and electronic health records were retrieved to

15
collect demographic and clinical data. Unscheduled routine follow-up examinations were conducted.
Participants who did not undergo a follow-up examination were considered lost to follow-up
(Supplementary Protocol). Postoperative adverse events were identified through review of
electronic health records by independent investigators who were unaware of the 5R 16S rRNA gene
sequencing results and the group assignments. The Data Safety Monitoring Board was responsible
for overseeing the safety, ethics, and implementation of the study protocol. An independent
statistician was responsible for the accuracy of the statistical analysis.
Outcomes
Primary endpoints include: (1) elucidating differences in bacterial composition within plaques
collected from patients with distinct disease types; (2) analyzing plaque-associated bacterial types
linked to adverse events. Secondary endpoints include: (1) identifying bacterial species within
plaques and their localization; (2) determining the potential functions of identified bacteria.
Statistical analysis
Statistical analyses were performed using IBM SPSS Statistics for Windows (version 24.0; IBM
Corporation, Armonk, NY, USA). Based on data normality, comparisons between two groups were
performed using the Student's t-test or Wilcoxon rank-sum test. Multiple comparisons of pathways
retrieved from the Kyoto Encyclopedia of Genes and Genomes (KEGG) were adjusted by
probability (p) values corrected for the false discovery rate. Clinical data are presented as the mean
± standard deviation or the median and interquartile range. For data with normal distribution and
homogeneous variance, one-way analysis of variance (ANOVA) was used to test differences among
multiple groups; otherwise, the Kruskal–Wallis test was applied. Count data are reported as
frequencies (percentages). Logistic regression analysis was conducted to assess the association
between bacteria and target outcome events. A p value < 0.05 was considered statistically
significant.

16
Bacteria in Atherosclerotic plaques
and adverse events
Case Report Form
Site ID: _________________________________
Patient ID: ___________________________________
Patient Initials: __________________________
ClinicalTrials.gov ID：NCT06935279
Date: 01 Jan 2024

Instructions for Completion
1.
Complete the Case Report Form for eligible participants;
2.
Complete clearly using a blue-black or black pen; do not write in shaded areas;
3.
This CRF must be used exclusively for the same subject throughout the entire trial;
4.
The investigator must sign the CRF as required;
5.
To avoid questioning each missing data point, every "□" or "○" must be filled in. Leaving a
space indicates "not selected." If an item is "Not Done," enter "ND"; for "Unknown," enter
"UK"; for "Not Available" or "Not Applicable," enter "NA." A "0" does not indicate missing
information but represents a meaningful numerical value;
6.
All numerical fields in the CRF are formatted as "
". Enter single-digit values in the
rightmost space. If spaces remain to the left, fill them with "0". Example: For a subject with
blood pressure of 120/80 mmHg, enter "Blood Pressure:
/
mmHg";
7.
All dates on forms, including the subject's date of birth, are expressed in "Year/Month/Day"
format. If the exact date is unknown, use "UK" and enter the date as "Year/Month/UK".
Provide the full date whenever possible. All times are recorded using the 24-hour clock.

Case Report Form
Part 1. Planned Visits

Screening and Enrollment
O1. Onset Time
O2. Inclusion Criteria
O3. Exclusion Criteria
O4. Informed Consent and Enrollment

O1 Onset Date
O1. Date of Onset:
Year
Month
Day, Time
Hour
Minute (24-hour
format)
O2
Inclusion Criteria
□
1. Patients clinically diagnosed with moderate-to-severe carotid artery stenosis
□
2. Age 18 ≤age ≤90
□
3. Patients undergoing carotid endarterectomy (CEA)
□
4. Preoperative mRS score for stroke patients:0-2
□
5. Preoperative NIHSS score for stroke patients: 0–20
□
6. Patient's Glasgow Coma Scale (GCS) score upon admission: 8-15 points
□
7. No fever or evidence of infection at admission
□
8. Informed consent signed by the subject or their legal representative
□
9. Good compliance with follow-up visits
* Onset time refers to "the time when symptoms first appeared," defined as "the last time the subject appeared normal."
O3
Exclusion Criteria
□
1. Brain tumor (presence of mass effect)
□
2. Patient Glasgow Coma Scale (GCS) score < 8
□
3. Refractory hypertension unresponsive to medication (defined as sustained systolic blood
pressure >185 mmHg or diastolic blood pressure >110 mmHg)
□
4. History of severe infection within the past three months
□
5. Severe or acute heart failure
□
6. Acute myocardial infarction or severe arrhythmia
□
7. Undergone major organ surgery or biopsy within the past month
□
8. Any active bleeding or recent bleeding (gastrointestinal, urinary tract, etc.) within the past
month

□
9. Currently undergoing hemodialysis or peritoneal dialysis; known severe renal impairment
(glomerular filtration rate < 220 mmol/L (2.5 mg/dL))
□
10. Concurrent malignant tumors, severe cardiopulmonary disease, or other conditions
rendering the patient unable to tolerate surgery
□
11. Has participated in other interventional clinical studies that may influence the outcome
assessment.
□
12. Severe liver function abnormalities.
□
13. Other circumstances deemed by the investigator to make participation in this study
inappropriate or pose significant risk to the patient (e.g., inability to understand and/or comply
with study procedures and/or follow-up due to psychiatric, cognitive, or emotional disorders)
□
14. Currently receiving immunosuppressive agents or undergoing immunotherapy
□
15. Severe chest or abdominal trauma requiring surgery、Severe Traumatic Brain Injury
□
16. Infectious Diseases such as Syphilis, AIDS, Hepatitis, and Tuberculosis
□
17. Patients with both hypertension and diabetes
O4
Informed Consent and Enrollment
O4.1 Has the patient or their legal representative signed the informed consent form?
○1 -No
○2 -Yes
O4.2 Date of informed consent signature by patient or legal representative (enrollment date):
Year
Month
Day
Hour
Minute (24-hour format)
O4.3 Was a copy of the informed consent form provided to the patient or their legal representative?
○1 -No
○2 -Yes
Investigator's Declaration: I confirm that this patient meets the inclusion criteria and should be
enrolled in this study. All information provided herein is true and reliable.
Investigator Signature:
Date of Signature:
Year
Month
Day

Visit 1: Baseline and Enrollment
Complete the following within 8 hours of patient enrollment:
A1. Basic Information
A2. Past Medical History
A3. Personal/Family History
A4. Medication History
A5. Clinical Examination
A6. Additional Tests

A1 Basic Information
A1.1 Preliminary Diagnosis: Moderate to Severe Carotid Artery Stenosis
A1.2 Outpatient ID: ____________
Hospital ID: ____________
A1.3 Gender: ○1- Male
○2- Female
A1.4
Age
years old
[ Note: Participants under 18 or over 90 years old are ineligible for
enrollment ]
A1.5 ID Number:
A1.6 Ethnicity: ○1- Han Chinese
○2- Other
A1.7 Contrast agent allergy
A1.8 Current Address: _______ Province, _______ City, _______ District/County
A1.9 Home Phone
－
A1.10 Mobile 1
A1.11 Mobile 2
A1.12 Mobile 3
A2 Medical History
A2.1 Onset Date:
Date:
Year:
Month:
Day: 24/01/2012 Time: 00:00:00 (24-hour format)
A2.2 Use of antiplatelet/anticoagulant drugs and intravenous thrombolysis after symptom onset:
Yes - Drug name and dosage:
Aspirin
Clopidogrel bisulfate
Alteplase
Rivaroxaban
Other_________________________________________
No
A3
Past Medical History
□A3.1 Hypertension:
Yes Hypertension present for
years
Highest blood pressure
/
mmHg;
Lowest blood pressure:
/
mmHg
No
□A3.2 Diabetes:
Yes Diabetes diagnosed
years ago
Diabetes
○1- Type 1
○2- Type 2
No
□A3.3 Hyperlipidemia:
Yes, already diagnosed
Year
No
□A3.4 Heart Disease
□1 -Coronary Heart Disease: If "Coronary Heart Disease," select specific type:

□1 - Angina pectoris. If "Angina pectoris" is selected, indicate the time of last occurrence:
○1 - ≤30 days
○2 - >30 days
□2 - Myocardial infarction. If "Myocardial infarction" is selected, last occurrence date
○1 -≤30 days
○2 -＞30 days
□3 - Other
□2 - Arrhythmia:
If "Arrhythmia," select specific type:
□1 - Atrial fibrillation
□2 -Atrial flutter
□3 - Conduction Disturbance (e.g., AV Block)
□4 - Sick sinus syndrome
□5 - Pacemaker Implantation
□6 - Other
□3 - Heart valve disease:
□4 - Heart valve replacement: Valve type ○1 - Bioprosthetic valve ○2 - Mechanical valve ○3 -
Unknown
□5 - Cardiac dysfunction
□6- Nonbacterial thrombotic endocarditis
□7 - Dilated cardiomyopathy
□8 -Rheumatic heart disease
□A3.4 Peripheral vascular disease: □Yes
Last occurrence ○1 -≤30 days
○2 -＞30 days
□No
□A3.5 Transient ischemic attack: □Yes
Last occurrence date ○1 -≤14 days
○2 -＞14 days
□No
□A3.6 Cerebral infarction: □Yes Date of most recent occurrence ○1 -≤6 months
○2 -＞6 months
□No
□A3.7 Cerebral hemorrhage
Last occurrence ○1 -≤6 months
○2 -＞6 months
□A3.8 Intracranial Aneurysm Single/Multiple
□A3.9 Intracranial arteriovenous malformation
□A3.10 Malignant tumor
□A3.11 Severe hepatic impairment
□A3.12 Chronic renal insufficiency
□A3.13 Gastrointestinal Ulcer
□A3.14 Gastrointestinal bleeding
□A3.15 Chronic Obstructive Pulmonary Disease (COPD)

□A3.16 Sleep apnea
□A3.17 Mental Disorders
□A3.18 Traumatic brain injury
A4 Personal/Family History
A4.1 Smoking:
○1 - Never smoked
○2 - Current smoker or quit within the past year
Daily Cigarette Consumption: ○1 -＜20 cigarettes
○2 -21-40 cigarettes
○3 -＞40
cigarettes
○3 - Former smoker, quit over 1 year ago
○4 -Unknown
A4.2 Alcohol consumption:
○1 - Never drinks alcohol
○2 -Previously drank, now abstinent
○3 - Currently drinks alcohol
If selected, daily alcohol consumption:
○1 -Moderate drinking: <2 standard drinks per day
○2 - Moderate drinking: ≥2, <5 standard drinks per day
○3
-Heavy drinking: ≥5 standard drinks/day
○4 -Dose unknown
○4 -Unknown
(Note: 1 standard drink (drink) is equivalent to 100ml [2 liang] of wine, 360ml [1 can] of beer, or 50ml
[approximately 1 liang] of high-proof spirits)
A5
(Note: Medication used continuously for more than 2 weeks within 6 months prior to onset)
□A5.1 Antiplatelet Agents:
If selected, specify type: □1- Aspirin □2 - Clopidogrel □3 - Ticagrelor □4 - Cilostazol □5
-Indomethacin □6 - Ozagrel □7 - Other__________ □8 Unknown
□A5.2 Anticoagulants:
If selected, specify type: □1 -Warfarin
□2 -Low molecular weight heparin
□3 -Unfractionated
heparin
□4 -Dabigatran
□5 -Rivaroxaban □6 -Apixaban □7 -Other__________ □8 -Unknown;
□A5.3 Antihypertensive drugs:
If selected, specify type: □1 -Calcium Channel Blockers (Calcium Channel Blockers: Amlodipine:
Norvasc, Candesartan, Losartan)
□2 -Angiotensin-Converting Enzyme Inhibitors (ACEI)
(Fosinopril, Benazepril) □3 - Angiotensin II receptor blockers (ARBs) (Losartan: Cozaar,

Hypertension; Telmisartan; Irbesartan: Avandart) □4-Diuretics (Hydrochlorothiazide, Spironolactone,
etc.) □5 -β-blockers (Bisoprolol)
□6 -α-blockers □7 -α/β-blockers
□8 -Other__________ □9
-Unknown;
□A5.4 Lipid-modifying drugs:
If applicable, please specify the type: □1 - Statins (Atorvastatin: □Lipitor □Atorvastatin;
Rosuvastatin: □Crestor □Simvastatin) □2 - Niacin and its derivatives (Amoxicillin, etc.) □3 -
Fibrates (Fenofibrate, Gemfibrozil, etc.) □4- Absorption inhibitors □5- Monoclonal antibodies (□
Iluostatin □Alisertib) □6- Lipitor □7- Bile acid sequestrants (e.g., cholestyramine) □8- Other
__________ □9- Unknown;
□A5.5 Antidiabetic drugs:
If applicable, specify type: □1- Insulin [IV or SC] (Humulin, Novolin) □2- Sulfonylureas
(Glimepiride, Gliclazide, Glibenclamide) □3- Biguanides (Metformin) □4 - Alpha-Glucosidase
Inhibitors (Acarbose: Glucobay, Capobay) □5 - Insulin Sensitizers
□6 - Non-Sulfonylurea Insulin
Secretagogues
□7 - Other__________
□8- Unknown;
□A5.6 Immunomodulatory drugs:
□A5.7 Traditional Chinese Medicines:
If applicable, please specify the type: □1- Dihydroergotamine (
) □2- Xingnaojing (
) □3-
Ginkgo Biloba Leaf □4- Aescin
□5 - Asarum sieboldii
□6 - Other__________ □7 - Unknown
A6
Clinical Examination
Physical Examination:
A6.1 Height
(centimeters, cm)
A6.2 Weight
(kilograms, kg)
A6.3 Waist Circumference
cm (1 chi = 33.33 cm)
A6.4 Initial Heart Rate on Admission
beats/min
A6.5 Initial pulse rate upon admission:
beats/minute
A6.6 Initial blood pressure on the healthy side brachial artery (supine position):
/
mmHg
Clinical Scores
A6.7 mRS score prior to current episode: [Note: Patients with mRS > 2 based on pre-onset
medical history are ineligible for enrollment]
○0 = Completely asymptomatic;
○1 = Symptoms present but no significant disability: Able to perform all usual duties and activities;
○2=Mild disability: Unable to perform all previously manageable activities, but capable of handling
personal affairs without assistance;

○3=Moderate disability: Requires some assistance, but does not need help walking;
○4=Severe disability: Unable to walk without assistance and unable to care for personal bodily needs;
○5=Severe disability: Bedridden, incontinent, requiring constant nursing and care.
A6.8 NIHSS Score: [Range0-42Points; higher scores indicate more severe neurological impairment]
○0-1 points: Normal or near-normal;
○1–4 points: Mild stroke/mini-stroke;
○5–15 points: Moderate stroke;
○16-20: Moderate-severe stroke;
○21–42 points: Severe stroke.
A6.9 Mini-Mental State Examination (MMSE) Total Score
points
Item
Points
Orientation
(10 points)
1. What day of the week is today?
What is today's date?
What month is it now?
What year is it?
What season is it now?
1
1
1
1
1
0
0
0
0
0
2. Where are you now?
Which floor are you on?
Which township (subdistrict) do you live in?
Which county (district) do you live in?
Which province do you live in?
1
1
1
1
1
0
0
0
0
0
Memory
(3 points)
3. I will tell you three things. After I finish, please repeat them and
remember them, as I will ask you again later (1 point each, total 3
points) Ball Flag Tree
3
2
1
0
Attention span
and calculation
skills
(5 points)
4.100-7=? Subtract 5 times consecutively (93, 86, 79, 72, 65. 1 point
each, total 5 points. If an answer is incorrect but the next one is
correct, only one error is counted).
5
4
3
2
1
0
Memory
(3 points)
5. Now, please tell me the things I just asked you to remember?
Soccer ball, national flag, trees
3
2
1
0
Language
Proficiency
(9 points)
6. Naming Ability
Present a watch and ask, "What is this?"
Present a pen and ask, "What is this?"
1
1
0
0
7. Repetition Ability
I will now say a phrase. Please repeat it clearly after me:
(Forty-four stone lions)!
1
0

8. Reading Ability
(Close your eyes) Please read this sentence aloud and follow the
instructions above!
1
0
9. Three-Step Command
I will give you a piece of paper. Please follow my instructions:
"Hold this paper with your right hand. Fold it in half with both hands.
Place it on your left thigh." (1 point per action, 3 points total)
3
2
1
0
10. Writing ability requires the subject to write a complete sentence.
1
0
11. Structural Ability
(Present the pattern) Please draw the pattern shown above!
1
0
A6.10 GCS Score:
Total Score
Checklist
GCS Scoring Criteria
Score
Assignment
Motor Response
6 - Normal (obeys commands); 5 - Can localize pain; 4 - Withdrawal response
to pain; 3 - Decorticate response to pain; 2 - Decerebrate response to pain; 1 -
No response
Verbal
Response
5 - Normal; 4 - Paraphrasing; 3 - Incoherent speech; 2 - Unintelligible; 1 - No
speech
Eye-opening
response
4－Spontaneous eye opening; 3－Eye opening upon verbal cue; 2－Eye
opening upon painful stimulus; 1－No eye opening to any stimulus
A6.11 Preoperative Control of Nutritional Status (CONUT) Score
○0–1 points: Normal nutritional status;
○1–2 points: Indicates mild malnutrition;
○2–4 points: Moderate to severe malnutrition.
[Note: The CONUT score is a method for assessing patient nutritional status. It is calculated primarily by evaluating
three indicators: serum albumin, total cholesterol, and lymphocyte count. 1. The normal range for serum albumin is
35–50 g/L. Values below this range indicate possible malnutrition; 2. Normal range for total cholesterol is 3.10–5.17
mmol/L. Values below this range indicate possible malnutrition; 3. Normal range for lymphocyte count is 1.0–3.5 ×
10⁹/L. Values below this range indicate possible malnutrition]
A6.12 Geriatric Nutritional Risk Index (GNRI)
GNRI ≥98: Good nutritional status, no nutritional risk;
92 ≤GNRI < 98: Mild malnutrition, moderate nutritional risk;
82 ≤GNRI < 92: Moderate malnutrition, moderate nutritional risk;
GNRI < 82: Severe malnutrition, high nutritional risk.
[Note: GNRI calculation formula: GNRI = [1.489 × Appetite Score + 41.7 × (Actual Weight / Ideal Weight)] / Serum
Albumin (g/L). The Appetite Score is based on the elderly individual's appetite status, while Ideal Weight is calculated
using the individual's height and age.]

A7
A7.1 Pre-enrollment Laboratory Tests
Blood Collection Date:
Year
Month
Day
Time:
Hour
Minute
Reference
values
Count
WBC - White Blood Cell
PSA-Prostate-Specific
LYMPH# - Absolute
PCA - Protein C activity
MONO# - Absolute
NT-proBNP - N-terminal
NEUT# - Absolute
cTnI - Cardiac Troponin
EO# - Eosinophil Absolute
MYO - Myoglobin
BASO# - Basophil
AST
-
Aspartate
PLT-Platelet Count
ALT
-
Alanine
PDW-Platelet Distribution
AST/ALT
MPV - Mean Platelet
TP - Total Protein
P-LCR-Large Platelet
ALB-Albumin
PCT - Prothrombin Time
GLO - Globulin
RBC-Red Blood Cell
A/G Ratio
HGB - Hemoglobin
TBIL - Total Bilirubin
HCT-Hematocrit
D-BIL - Direct Bilirubin
MCV - Mean Corpuscular
I-BIL - Indirect Bilirubin
MCH - Mean Corpuscular
MCHC - Mean
ALP
-
Alkaline
RDW%-Red Cell
Na - Sodium
PT - Prothrombin Time
CL - Chloride
APTT - Activated Partial
Ca - Calcium
Fib-Fibrinogen level
CO2-Carbon Dioxide
TT-Thrombin Time
Carbon Dioxide Binding
FDP-Fibrin(ogen)
cys-c (cystatin C)
D-D (D-dimer)
BUN-Blood
Urea
TM
Cr-Creatinine
TAT
eGFR (CKD)
PIC
UA-Uric Acid

Reference
values
Count
tPAI-C (tissue-type
UREA-Urea
ATA-Antithrombin III
CK-Creatine Kinase
LDH-Lactate
VB12-Vitamin B12
Folate
TC-Total Cholesterol
R (R-value)
TG-Triglycerides
Angle-Angle
HDL-C - High-Density
MA-MA value
LDL-C-Low-Density
CI-CI Score
APOA-Apolipoprotein A1
LY30-LY30 value
APOB-Apolipoprotein B
EPL-EPL value
Lp(a) - Lipoprotein(a)
PAI-1 (PAI-1 rs1799889
HCY-Homocysteine
CYP2C19 (Clopidogrel)
HbA1c - Glycated
APOE
(ApoE
gene
GLU - Fasting Blood
ABO
CRP - C-reactive protein
A7.2 ECG Findings
○1 -Normal
○2 -Abnormal*
*If "Abnormal", please select:
□1 -Atrial/Ventricular Fibrillation
□2- Atrial/Ventricular Flutter
□3 - Sick sinus syndrome
□4 -Second- or third-degree atrioventricular block
□5 -Sinus bradycardia or heart rate <50 bpm
□99 - Other
A7.3 Preoperative Imaging Studies
A7.3.1 Preoperative head CT or MRI examination
Date:
Year:
Month:
Day: Time:
Hour:
Minute:
A7.3.2 Infarction Types and Recovery Levels
Infarction Type:
口
Complete anterior circulation infarction
口
Partial anterior
circulation infarction 口Posterior circulation infarction 口Focal infarction
Recovery Status: Infarct shrinkage or disappearance 口Yes 口No
Cerebral Function Recovery: mRS Score Improvement 口Yes 口No
[Note: 1. Complete anterior circulation infarction: Manifested as triad symptoms, i.e., complete middle cerebral
artery syndrome; Higher-level cerebral dysfunction (consciousness disturbance, aphasia, acalculia, spatial
disorientation, etc.); homonymous hemianopia, and severe motor and/or sensory deficits in three contralateral
areas (face, upper limb, lower limb). Most cases involve occlusion of the proximal trunk of the middle cerebral

artery, with a minority caused by occlusion of the internal carotid artery siphon segment, resulting in extensive
cerebral infarction. 2. Partial anterior circulation infarction: Presents with two of the above triad features, or solely
higher-level neurological impairment, or sensory-motor deficits more localized than in complete anterior
circulation infarction. Indicates infarction in the distal trunk, branches, or small-to-medium vessels of the middle
cerebral artery, or occlusion of branches associated with anticardiolipin antibodies. 3. Posterior circulation
infarction: Manifested as vertebrobasilar syndrome of varying severity; may present as ipsilateral cranial nerve
palsy with contralateral sensory-motor deficits; bilateral sensory-motor deficits; binocular coordination and
cerebellar dysfunction without long tract signs or visual field defects. Caused by occlusion of the vertebral-basilar
arteries and their branches, resulting in brainstem and cerebellar infarcts of varying sizes. 4. Lacunar infarction:
Manifested as lacunar syndrome, such as pure motor hemiparesis, pure sensory stroke, ataxic hemiparesis, or
clumsy hand-dysarthria syndrome. Most cases involve small lacunar lesions caused by lesions in the basal ganglia
or small perforating vessels of the pons.
A7.3.3 Assessment of Vascular Stenosis Severity and Location
Assess the degree of cervical vascular stenosis via CTA, MRA, DSA, or US：
Mild
Moderate
Severe
Narrow section: Carotid artery
Vertebral artery
Intracranial arteries
Subclavian
artery
Bilateral
Left
Right
Multiple
Isolated
A7.3.4 Preoperative Magnetic Resonance Cerebral Perfusion Imaging Evaluation
TTP
(Normal/Prolonged)
MTT
(Normal/Prolonged)
rCBF
(Normal/Prolonged)
rCBV
(Normal/Prolonged)
[Note: 1. Time to peak (TTP): The time from when the contrast agent reaches the main artery supplying the
imaged brain region until it reaches its maximum concentration (s); 2. Mean transit time (MTT): The time
required for the contrast agent to traverse from the arterial to the venous side within the cranium, averaged
across all transit times (s); 3. Cerebral Blood Flow (CBF): Blood flow in milliliters per minute per 100 g of
brain tissue [ml/(100g·min)]. In humans, gray matter is approximately: 80 ml/(100g·min); white matter: 20
ml/(100g·min); 4. Cerebral blood volume (CBV): Blood volume per 100 g of brain tissue [ml/100g]. Normal
adult values range from approximately 4 to 5 ml.
A7.3.5 Preoperative Carotid Ultrasound Examination
Patch characteristics: Soft patch □
Fibrous patch □
Calcified patch □
Mixed patch □Other □
Plaque Echo: Hypoechoic □
Isoechoic □
Hyperechoic □
Mixed Echo □
A7.3.6 Bubble test
Positive □
Negative
□
A7.4 Preoperative Chest CT Scan (within 24 hours of onset)
A7.4.1 Preoperative Chest CT Scan
Date
, Time
(24-hour format)
A7.4.2 Presence of shadow, infiltration, or cavity: ○1 -No
○2 -Yes
A7.4.3 Location of lesion:
□1 - Left upper lobe
□2 - Left lower lobe
□3 - Right upper lobe
□4 - Right
middle lobe
□5 - Right lower lobe
A7.4.4 Lesion cross-section Length
.
cm
Width
.
cm
Number of layers
.
layers
Layer thickness
.
cm
Lesion volume
.
cm³/ml

A7.4.5 Has the lesion enlarged since the previous examination? (This item may be left blank
for the initial chest CT): ○1 - No
○2 - Yes
A7.4.6 Is the lesion associated with pleural effusion? ○1 - No
○2 - Yes
Schedule next follow-up: ≤6 hours post-surgery
Visit
1
Completed
Physician
Signature: ________________
Signature Date:
Year
Month
Day

Visit 2: ≤6 hours post-op
You must complete the following within 6 hours post-surgery:
B1. Visit Time
B2. Operating Room Care
B3. Anesthesia Management
B4. Intraoperative Medical Management
B5. Adverse Events

B1
Visit Date
B1. Visit Date
B2. Operating Room Nursing
B 2.1 Operating Room Parameters
Room Temperature:
℃
Humidity:
%.
B 2.2 Room Entry/Exit Times:
Entry:
:
;
Departure:
hours
minutes;
Total time:
hours
minutes
B 2.3 Surgery Duration:
Start:
:
;
End:
hours
minutes;
Total Duration:
hours
minutes
B 2.4 State of Consciousness Upon Entry:
Aware ○
Drowsy ○
Comatose ○
Superconscious ○
Consciousness upon discharge:
Alert ○
Drowsy ○
Comatose ○
Mildly Comatose ○
B2.5 Psychological State
Tense○
Anxious○
Calm○
Indifferent○
B2.6 Catheterization Method
Post-anesthesia ○
Pre-anesthesia ○
B2.7 Antibiotic Prophylaxis Status:
If selected, specify type: □1 - First/second-generation cephalosporins (Cefazolin, Cefuroxime)
□2 - Third-generation cephalosporins (Ceftriaxone)
□3 - Other__________
B2.8 Infusion Reaction:
○Smooth, no adverse infusion reactions
○With _______________
B2.9 Hypothermia Prevention:
Body Temperature: Upon Entry:
℃;
Maintained: <36℃□36-37℃□>37℃□
Heated Blanket: Present □
Absent □
Temperature
℃
B2.10 Pressure Ulcer Prevention:
Intraoperative Position: Supine Position□Lateral Position□(Left□Right□)
Pressure Point Care: □Head (Pillow.Ears.Eyes) □Torso (Shoulders.Iliac Crests.Sacrococcyx) □
Limbs (Elbows.Knees.Heels.Toes)
Care Frequency: 1-2 times/day □3-4 times/day □5-6 times/day □7-8 times/day □
9-10 times/day □>10 times/day
B3 Anesthesia Management
B 3.1 Anesthesia Duration and Method:

Start:
:00
:00;
End:
hours
minutes;
Total Duration:
hours
minutes
Anesthesia method: Intravenous
Inhalation
Combined
B 3.2 Anesthesia Monitoring Parameters:
Arterial Blood Gas
Pre-induction blood pressure:
/
mmHg
Intraoperative Circulatory Status:
Stable
Hypoperfusion: Duration:
minutes
Fluid output: Blood loss ml; Urine output ml;
Total: ml
Fluid Replacement Volume: Crystalloid ml; Colloid ml;
Total: ml
Transfusion Volume:
None
Yes: Red Blood Cells
Units; Plasma ml; Cryoprecipitate
Units
Transfusion Reaction:
None
Yes
B 3.3 Post-anesthesia assessment:
Level of Consciousness Scale: Level 0
Level 1
Level 2
Level 3
Level 4
Steward Score: Total Score
= Level of Consciousness
+ Respiration
+ Motor Response
Level of Consciousness: 2 points, fully alert; 1 point, responsive to stimulation; 0 points,
unresponsive to stimulation;
Airway patency: 2 points, coughs on command; 1 point, spontaneously maintains airway patency;
0 points, requires airway support
Limb Activity: 2 points, conscious limb movement; 1 point, unconscious limb movement; 0 points,
no movement
Extubation before leaving the operating room: Yes
With spontaneous breathing but not
extubated
Without spontaneous breathing
B4 Intraoperative Medical Management
B 4.1 Surgical Duration and Approach:
Start:
hours
minutes;
End:
hours
minutes;
Total Duration:
hours
minutes
Carotid Endarterectomy (Plaster Removal): Left
Right
Surgical Incision Local Anesthesia: None
Yes
Drug: Lidocaine
Ropivacaine
Other:
B 4.2 Intraoperative Monitoring Parameters: (Post-anesthesia induction)
Blood pressure monitoring:
Initial Surgical Blood Pressure:
/
mmHg
End of surgery blood pressure:
/
mmHg
Blood pressure at vascular occlusion initiation:
/
mmHg
Blood pressure at end of vascular occlusion:
/
mmHg

Cerebral Oxygen Monitoring:
Pre-operative cerebral oxygenation:
%
Cerebral oxygen monitoring at end of surgery:
%
Cerebral Oxygen Monitoring at the Start of Vascular Occlusion:
%
End of cerebral oxygen monitoring after vascular occlusion:
%
Electrophysiological Monitoring:
Motor Evoked Potentials (MEPs)
Alert
Normal
Somatosensory Evoked Potentials (SSEPs)
Alert
Normal
Electroencephalogram (EEG)
Alert
Normal
TCD Monitoring (Transcranial Doppler Ultrasound)
PSV
EDV_______________MFV_______________
Intraoperative arterial clamping time:
minutes
B 4.2 Intraoperative Medical Management:
Intraoperative Microscope Use:
Drainage tube placement: Extra-carotid sheath
Intra-carotid sheath
Drainage tube removal time: <24h
24-48h
>48h
Drainage volume:
ml
Arterial sheath suturing: Absorbable suture
Non-absorbable suture
(Tight
Loose
)
Subcutaneous Suture:
Absorbable suture
Non-absorbable suture
(Interrupted
Continuous
)
Skin Suturing:
Absorbable sutures
Non-absorbable sutures
(Interrupted
Subcutaneous
)
Skin incision length:
cm
B5 Adverse Events
B5.1 Have any adverse events occurred since enrollment?
○1- No
○2- Yes
If "No" is selected, no further completion is required.
B5.2
In the event of an adverse event, please select:
For any adverse event/serious adverse event, please complete the Adverse Event/Serious Adverse
Event Report Form (see attachment).
1. Date of death
, Time
(24-hour format)
Cause of Death:
○1-Vascular Cause of Death
○1 - Death due to ischemic stroke
○2 - Death from hemorrhagic stroke
○3 - Sudden cardiac death

○4 - Death from Acute Myocardial Infarction
○5 - Death from congestive heart failure
○6 - Pulmonary embolism
○7-Death from cardiovascular/cerebrovascular intervention or surgery (unrelated to acute
myocardial infarction)
○8 - Other vascular-related deaths
○2-Non-vascular cause death
○3-Unknown cause
2. New-onset postoperative cerebral infarction
Yes ○No ○
First event date:
Date:
Year
Month
Day,
Hour
Minute (24-hour format)
Infarction location______________
Infarction area______________
Does it cause corresponding symptoms? ○1 -No
○2 -Yes If yes: Please describe symptoms
Determination of cervical vascular stenosis severity via CTA, MRA, DSA, or US (Mild
;
Moderate
;
Severe
; Total occlusion
)
3. Re-bleeding
Time
Hours
Minutes (24-hour format)
3.1 Completed cranial imaging studies: □1CT □2MRI
3.2 Type and location
Subdural hematoma: Left
Right
Bilateral
Subpial
Epidural hematoma: Left
Right
Bilateral
Subdural;
Intracerebral hematoma: Left
Right
Bilateral
Subtentorial
Subarachnoid hemorrhage:
Basal cistern
Lateral fissure
Interpeduncular cistern
Others
Ventricular hemorrhage: Left ventricle
Right ventricle
Third ventricle
Fourth ventricle
Does it cause corresponding symptoms? ○1 -No
○2 -Yes If yes: Please describe the
symptoms
Has it penetrated the ventricle? ○1 -No
○2 -Yes
Does it rupture into the subarachnoid space: ○1 -No
○2 -Yes
Midline shift: ○1 -No
○2 -Yes
Is cerebral herniation present: ○1 -No
○2 -Yes
4. CoagulationAbnormalities
Time
hours
minutes (24-hour format)
4.1 Abnormal Coagulation Markers:
□1 -PT ○1 -Elevated
○2 -Decreased;
□2 - INR ○1 -Elevated
○2 -Decreased;□3 -
APTT ○1 - Elevated
○2 - Decreased;
□4 - Fbg ○1 - Elevated
○2 - Decreased;
□5 - TT ○1 - Elevated
○2 - Decreased;
□6 - FDP ○1 - Elevated
○2 - Decreased;
□7 - DD ○1 - Elevated
○2 - Decreased
5.AbnormalAbsolute Platelet Count
Time
Hours
Minutes (24-hour format)
5.1 Absolute Platelet Count:
10^9/L

6. Bleeding from Various Organs
Time
H
Min (24-hour format)
6.1 Bleeding site: □1 - Gastrointestinal tract
□2 - Respiratory tract
□3 - Urinary tract
□4 - Other organs
□5 - Other
□6 - Unknown
7. Abnormal Liver Function
Time
Hours
Minutes (24-hour format)
8. Renal Function Abnormalities
Time
Hours
Minutes (24-hour format)
9. Infection
Time
Hour
Minute (24-hour format)
Site of Infection: □1 - Gastrointestinal Tract
□2 - Respiratory Tract
□3 - Urinary Tract
□4 - Other
□5 - Unknown
10. Myocardial infarction
Time
Time
Minutes (24-hour format)
11. Lower Extremity Venous Thrombosis
Time
Hours
Minutes (24-hour format)
12. Pulmonary embolism
Time
hours
minutes (24-hour format)
13. Hyperlipidemia
Time
Hours
Minutes (24-hour format)
14. Bradycardia
Time
H
M (24-hour format)
15. Rash/Drug Allergy
Time
H
M (24-hour format)
16. Diarrhea
Time
hours
minutes (24-hour format)
17. Elevated blood sugar
Time
Hours
Minutes (24-hour format)
18. Other
Name: ________________;
Time
Hours
Minutes (24-hour format)
Next Visit Scheduled: 72±12 hours post-surgery
Visit 2 Completed Physician Signature: ________________
Signature Date:
Year
Month
Day

Visit 3: 72 ± 12 hours post-op
You must complete the following within 72 ± 12 hours post-surgery:
C1. Visit Time
C2. Adverse events
C3. Clinical Examination
C4. Imaging studies
C5. Concomitant Medications

C1
Visit Date
C1. Visit Date
C2 Adverse Events
C2.1 Have any adverse events occurred since enrollment?
○1 -No
○2 -Yes
If "No" is selected, proceed directly to Section C3.
C2.2
If an adverse event occurred, please select:
If any adverse event/serious adverse event has occurred, complete the Adverse Event/Serious Adverse
Event Report Form (see attachment).
1. Date of Death
, Time
(24-hour format)
Cause of Death:
○1-Vascular Cause Death
○1 - Death due to ischemic stroke
○2 - Death from hemorrhagic stroke
○3 - Sudden cardiac death
○4- Death from Acute Myocardial Infarction
○5 - Death from congestive heart failure
○6 - Pulmonary embolism
○7 - Death from cardiovascular/cerebrovascular intervention or surgery (unrelated to acute
myocardial infarction)
○8 - Other vascular-related deaths
○2-Non-vascular cause death
○3-Unknown cause
2. New-onset postoperative cerebral infarction
Yes ○No ○
First event date:
Date:
Year:
Month:
Day:
Hour:
Minute (24-hour format)
Infarction location______________
Infarction area______________
Caused corresponding symptoms ○1 -No
○2 -Yes If yes: Please describe symptoms
3. Re-bleeding
Time
hours
minutes (24-hour format)
3.1 Completed cranial imaging studies: □1CT □2MRI
3.2 Type and location
Subdural hematoma: Left
Right
Bilateral
Subpial
Epidural hematoma: Left
Right
Bilateral
Subdural;
Intracerebral hematoma: Left
Right
Bilateral
Subtentorial
Subarachnoid hemorrhage: Basal cistern
Lateral fissure
Interpeduncular cistern
Others
Ventricular hemorrhage: Left ventricle
Right ventricle
Third ventricle
Fourth ventricle
Does it cause corresponding symptoms? ○1 -No
○2 -Yes If yes: Please describe the
symptoms

Has it penetrated the ventricle? ○1 -No
○2 -Yes
Does it rupture into the subarachnoid space: ○1 -No
○2 -Yes
Midline shift: ○1 -No
○2 -Yes
Brain herniation: ○1 -No
○2 -Yes
4. CoagulationAbnormalities
Time
hours
minutes (24-hour format)
4.1 Abnormal Coagulation Markers:
□1 -PT ○1 -Elevated
○2 -Decreased;
□2 - INR ○1 -Elevated
○2 -Decreased;
□3 - APTT ○1 - Elevated
○2 - Decreased; □4 - Fbg ○1 - Elevated
○2 - Decreased;
□5 - TT ○1 - Elevated
○2 - Decreased;
□6 - FDP ○1 - Elevated
○2 - Decreased;
□7 - DD ○1 - Elevated
○2 - Decreased
5.AbnormalAbsolute Platelet Count
Time
Hours
Minutes (24-hour format)
5.1 Absolute Platelet Count:
10^9/L
6. Bleeding from various organs
Time
hours
minutes (24-hour format)
6.1 Site of bleeding: □1 - Digestive tract
□2 - Respiratory tract
□3 - Urinary tract
□4 -
Other organs
□5 - Other
□6 - Unknown
7. Abnormal Liver Function
Time
Hours
Minutes (24-hour format)
8. Renal Function Abnormalities
Time
Hours
Minutes (24-hour format)
9. Infection
Time
Hours
Minutes (24-hour format)
Site of Infection: □1 - Gastrointestinal Tract
□2 - Respiratory Tract
□3 - Urinary System
□4 - Other
□5 - Unknown
10. Myocardial infarction
Time
Hours
Minutes (24-hour format)
11. Lower Extremity Venous Thrombosis
Time
hours
minutes (24-hour format)
12. Pulmonary embolism
Time
Hours
Minutes (24-hour format)
13. Hyperlipidemia
Time
Hours
Minutes (24-hour format)
14. Bradycardia
Time
H
M (24-hour format)
15. Rash/Drug Allergy
Time
H
M (24-hour format)
16. Diarrhea
Time
hours
minutes (24-hour format)
17. Hyperglycemia
Time
Hours
Minutes (24-hour format)
18. Other
Name: ________________;
Time
:
(24-hour format)
C3
Clinical Examination
Physical Examination:
C3.1 72±12-hour follow-up visit
Heart rate:
beats/min
C3.2 72±12-hour follow-up visit Pulse rate:
beats/min
C3.3 72±12-hour follow-up
Systolic Blood Pressure 1 (Supine Position, Systolic Reading):
/
mmHg
Systolic Blood Pressure 2 (Supine Position, Systolic Reading):
/
mmHg
Diastolic Blood Pressure 1 (Supine Position, Systolic Priority):
/
mmHg

Diastolic Blood Pressure 2 (supine position, systolic measurement):
/
mmHg
C3.4 72±12-hour follow-up visit
Highest respiratory rate within 24 hours:
breaths/min
Highest body temperature within 24 hours:
.
°C
Sputum characteristics:
purulent sputum
clear sputum
no sputum
Cough:
Yes
No
Shortness of breath (wheezing, labored breathing):
Yes
No
Lung auscultation:
Rales
Wet rales
Bronchial breath sounds
Other:________________;
Nasal endotracheal intubation:
Yes
No
Endotracheal intubation:
Yes
No
Date of intubation: Date
Year
Month
Day,
Time
Hours
Minutes (24-hour format)
Ventilator-assisted ventilation:
Yes
No
Ventilator-assisted ventilation start time: Date
Year
Month
Day,
Time
Hour
Minute (24-hour format)
Ventilator oxygen concentration fraction (FiO2 = 0.21 + oxygen flow rate / 25):
.
%
Arterial Blood Gas Partial Pressure of Oxygen (PaO₂):
.
mmHg
Clinical Scores
C3.2 NIHSS Score: [Range0-42Points; higher scores indicate more severe neurological impairment]
○0-1 points: Normal or near-normal;
○1-4 points: Mild stroke/mini-stroke;
○5–15 points: Moderate stroke;
○16–20: Moderate-to-severe stroke;
○21–42 points: Severe stroke.
C3.3 mRS Score [Note: Score based on condition at the time of this visit]
○0=Completely asymptomatic;
○1=No significant disability despite symptoms: Able to perform all duties and activities previously
undertaken;
○2 = Mild disability: Unable to perform all previously undertaken activities, but able to manage
personal affairs without assistance;
○3 = Moderate disability: Requires some assistance, but does not need help walking;
○4=Severe disability: Unable to walk without assistance and unable to care for personal bodily needs;
○5=Severe disability: Bedridden, incontinent, requiring constant nursing and care.
C4 Imaging Studies
C4.1 Postoperative Cranial CT or MRI
Date:
Year:
Month:
Day:
Time:
Type of Infarction and Recovery Status
Ischaemic Type: √Complete anterior circulation ischaemia √Partial anterior circulation

ischaemia √Posterior circulation ischaemia √Focal ischaemia
Recovery Level: Infarct shrinkage or disappearance 口Yes 口No
Cerebral Function Recovery: mRS Score Improvement 口Yes 口No
[Note: 1. Complete anterior circulation infarction: Manifested as triad symptoms, i.e., complete middle cerebral
artery syndrome; Higher-level cerebral dysfunction (consciousness disturbance, aphasia, acalculia, spatial
disorientation, etc.); homonymous hemianopia, and severe motor and/or sensory deficits in three contralateral
areas (face, upper limb, lower limb). Most cases involve occlusion of the proximal trunk of the middle cerebral
artery, with a minority caused by occlusion of the internal carotid artery siphon segment, resulting in extensive
cerebral infarction. 2. Partial anterior circulation infarction: Presents with two of the above triad features, or solely
higher-level neurological impairment, or sensory-motor deficits more localized than in complete anterior
circulation infarction. Indicates infarction in the distal trunk, branches, or small-to-medium vessels of the middle
cerebral artery, or occlusion of branches associated with anticardiolipin antibodies. 3. Posterior circulation
infarction: Manifested as vertebrobasilar syndrome of varying severity; may present as ipsilateral cranial nerve
palsy with contralateral sensory-motor deficits; bilateral sensory-motor deficits; binocular coordination and
cerebellar dysfunction without long tract signs or visual field defects. Caused by occlusion of the vertebral-basilar
arteries and their branches, resulting in brainstem and cerebellar infarcts of varying sizes. 4. Lacunar infarction:
Manifested as lacunar syndrome, such as pure motor hemiparesis, pure sensory stroke, ataxic hemiparesis, or
clumsy hand-dysarthria syndrome. Most cases involve small lacunar lesions caused by lesions in the basal ganglia
or small perforating vessels of the pons.
C4.2 Postoperative Assessment of Revascularization
Is the surgical site patent? Yes
No
Determination of cervical vascular stenosis severity via CTA, MRA, DSA, or US (Mild
;
Moderate
;
Severe
; Total occlusion
)
C4.3 Follow-up chest CT scan without contrast (72±12 hours after onset)
B4.2.1 Follow-up chest CT scan (72±12 hours after onset)
Date
, Time
(24-hour format)
B4.2.2 Presence of shadows, infiltration, or cavities: ○1 -No
○2 -Yes
B4.2.3 Location of lesion:
□1 - Left upper lobe
□2 - Left lower lobe
□3 - Right upper lobe
□4 - Right
middle lobe
□5 - Right lower lobe
B4.2.4 Lesion cross-section Length
.
cm
Width
.
cm
Number of layers
.
layers
Layer thickness
.
cm
Lesion volume
.
cm³/ml
B4.2.5 Has the lesion enlarged since the previous examination? (This item may be left blank
for the initial chest CT): ○1 - No
○2 - Yes
B4.2.6 Is the lesion associated with pleural effusion? ○1- No
○2- Yes
C4.4 Laboratory Tests
Blood draw date:
Year
Month
Day
Time:
Hour
Minute (24-hour format)
Visits:
WBC - White Blood Cell
PSA-Prostate-Specific
LYMPH# - Absolute
PCA - Protein C activity

Visits:
MONO# - Absolute
NT-proBNP - N-terminal
NEUT# - Neutrophil
cTnI - Cardiac Troponin
EO# - Eosinophil Absolute
MYO-Myoglobin
BASO# - Basophil
AST
-
Aspartate
PLT-Platelet Count
ALT
-
Alanine
PDW-Platelet Distribution
AST/ALT
MPV - Mean Platelet
TP - Total Protein
P-LCR-Large Platelet
ALB-Albumin
PCT - Prothrombin Time
GLO-Globulin
RBC-Red Blood Cell
A/G Ratio
HGB - Hemoglobin
TBIL - Total Bilirubin
HCT-Hematocrit
D-BIL - Direct Bilirubin
MCV - Mean Corpuscular
I-BIL-Indirect Bilirubin
MCH - Mean Corpuscular
MCHC - Mean
ALP
-
Alkaline
RDW%-Red Cell
Na - Sodium
PT - Prothrombin Time
CL - Chloride
APTT - Activated Partial
Ca - Calcium
Fib-Fibrinogen level
CO2-Carbon Dioxide
TT-Thrombin Time
Carbon Dioxide Binding
FDP-Fibrin(ogen)
cys-c (cystatin C)
D-D (D-dimer)
BUN-Blood
Urea
TM
Cr-Creatinine
TAT
eGFR (CKD)
PIC
UA-Uric Acid
tPAI-C (tissue-type
UREA-Urea
ATA-Antithrombin III
CK-Creatine Kinase
LDH-Lactate
VB12-Vitamin B12
Folate

Visits:
TC - Total Cholesterol
R (R-value)
TG - Triglycerides
Angle-Angle
HDL-C-High-Density
MA-MA Value
LDL-C - Low-Density
CI-CI value
APOA-Apolipoprotein A1
LY30-LY30 value
APOB-Apolipoprotein B
EPL-EPL value
Lp(a) - Lipoprotein(a)
PAI-1 (PAI-1 rs1799889
HCY-Homocysteine
CYP2C19 (Clopidogrel)
HbA1c - Glycated
APOE
(ApoE
gene
GLU - Fasting Blood
ABO
CRP - C-reactive protein
C5 Concomitant Medications
C5.1 Please complete medication consolidation
Schedule next visit: 30 days post-surgery
Visit 3 Completed Physician Signature: ________________
Signature Date:
Year
Month
Day

Discharge Record
Please complete upon subject discharge
G1
Basic Discharge Information
1.1
Discharge Date:
-
-
1.2
Hospitalization ID
G2
Discharge Diagnosis
2.1
Final Diagnosis at Enrollment: Moderate to Severe Carotid Stenosis
F2.1.1 Degree of Stenosis:
F2.1.2 Site of Stenosis:
2.2
Other Diagnoses:
□1. Hypertension:
If "Hypertension," select type: ○1- Primary Hypertension (
) ○2- Secondary
Hypertension
Hypertension Grading:
○1 - Stage 1:
Systolic blood pressure 140-159 mmHg and/or diastolic blood pressure
90-99 mmHg
○2 - Grade 2: Systolic blood pressure 160-179 mmHg and/or diastolic blood pressure
100-109 mmHg
○3 - Grade 3:
Systolic blood pressure ≥180 mmHg and/or diastolic blood pressure
≥110 mmHg
□2. Diabetes
□3. Dyslipidemia
□4. Coronary heart disease
□5. Arrhythmia
If "Arrhythmia" is selected, then:

□1 - Paroxysmal atrial fibrillation
□2 - Persistent atrial fibrillation
□3 -
Permanent atrial fibrillation
□4 - Atrial flutter
□5 - Frequent premature beats
□6 - Other
□6. Respiratory System Diseases
If selecting "Respiratory System Diseases," please choose
○1 - Pulmonary infection
○2 - Pulmonary embolism
○3 - Asthma
○4 - COPD
○5 - Hemoptysis
○6 - Other
□7. Liver Disease
□1 -Abnormal liver function
□2 -Viral carrier
□3 -Cirrhosis
□4 -Liver surgery
□5 -Other
□8. Urinary System Diseases
□1 - Chronic renal insufficiency
□2 - Urinary tract infection
□3 - Urinary tract
hemorrhage
□4- Other
□9. Digestive System Diseases
□1 - Digestive System Ulcers
□2 - Digestive System Bleeding
□3 - Other
□10. Peripheral Arterial Disease
□11. Deep Vein Thrombosis
□12. Cognitive Impairment
□13. Epilepsy
Discharge Information Collection
○1 -No
○2 -Yes
Photograph and upload discharge summary
○1 -No
○2 -Yes
mRS score at discharge: [Note: Based on pre-onset medical history assessment,

patients with mRS > 2 are ineligible for enrollment]
○0 = Completely asymptomatic;
○1=Symptoms present but no significant disability: Able to perform all previously
engaged duties and activities;
○2 = Mild disability: Unable to perform all previously engaged activities, but can
manage personal affairs without assistance;
○3 = Moderate disability: Requires some assistance, but can walk without help;
○4 = Severe disability: Unable to walk without assistance and unable to care for
personal bodily needs;
○5=Severe disability: Bedridden, incontinent, requiring constant nursing and care.
NIHSS score at discharge: [Range0-42Points; higher scores indicate more severe neurological
impairment]
○0-1 points: Normal or near-normal;
○1–4 points: Mild stroke/mini-stroke;
○5–15 points: Moderate stroke;
○16-20: Moderate-severe stroke;
○21–42 points: Severe stroke.

Item
Score
Orientation
(10 points)
1. What day of the week is today?
What is today's date?
What month is it now?
What year is it?
What season is it now?
1
1
1
1
1
0
0
0
0
0
2. Where are you now?
Which floor are you on?
Which township (subdistrict) do you live in?
Which county (district) do you live in?
Which province do you live in?
1
1
1
1
1
0
0
0
0
0
Memory
(3 points)
3. I will tell you three things. After I finish, please
repeat them and remember them, as I will ask you again
later. (1 point each, total 3 points) Ball Flag Tree
3
2
1
0
Attention span
and calculation
skills
(5 points)
4.100-7=? Subtract 5 five times consecutively (93, 86,
79, 72, 65. 1 point each, total 5 points. If an answer is
incorrect but the next one is correct, only one error is
counted)
5
4
3
2
1
0
Memory
(3 points)
5. Now, please tell me the things I just asked you to
remember? Soccer ball, national flag, trees
3
2
1
0
Language
Proficiency
(9 points)
6. Naming Ability
Present a watch and ask, "What is this?"
Present a pen and ask, "What is this?"
1
1
0
0
7. Repetition Ability
I will now say a phrase. Please repeat it clearly
after me: (Forty-four stone lions)!
1
0

8. Reading Ability
(Close your eyes) Please read this sentence aloud
and follow the instructions above!
1
0
9. Three-Step Command
I will give you a piece of paper. Please follow my
instructions: "Hold this paper with your right hand. Fold
it in half with both hands. Place it on your left thigh." (1
point per action, 3 points total)
3
2
1
0
10. Writing ability requires the subject to write a
complete sentence.
1
0
11. Structural Ability
(Present a pattern) Please draw the pattern shown
above!
1
0
GCS Score:
Total Score
Checklist
GCS Scoring Criteria
Score
Motor
Response
6－Normal (obeys commands); 5－Can localize pain site; 4－
Avoidance response to pain; 3－Decorticate response to pain; 2－
Decerebrate response to pain; 1－No response
Verbal
Response
5 - Normal; 4 - Paraphrasing; 3 - Incoherent speech; 2 - Unable to
understand; 1 - No speech
Eye-opening
response
4 - Spontaneous eye opening; 3 - Eye opening in response to
verbal call; 2 - Eye opening in response to painful stimulus; 1 - No
eye opening to any stimulus

Visit 4: 30 ± 2 days post-op
You must complete the following within 30 ± 2 days
post-surgery:
D1. Visit Time
D2. Adverse events
D3. Clinical examination
D4. Imaging studies
D5. Concomitant Medications

D1
Visit Date
D1. Visit Date
D2 Adverse Events
D2.1 Have any adverse events occurred since enrollment?
○1- No
○2- Yes
If "No" is selected, proceed directly to Section D3.
D2.2 If an adverse event occurred, please select:
For any adverse event/serious adverse event, complete the Adverse Event/Serious
Adverse Event Report Form (see attachment).
1. Date of Death
, Time
(24-hour format)
Cause of Death:
○1-Vascular Cause Death
○1 - Death due to ischemic stroke
○2 - Death from hemorrhagic stroke
○3 - Sudden cardiac death
○4- Death from Acute Myocardial Infarction
○5 - Death from congestive heart failure
○6 - Pulmonary embolism
○7 - Death from cardiovascular/cerebrovascular intervention or surgery (unrelated
to acute myocardial infarction)
○8 - Other vascular-related deaths
○2-Non-vascular cause death
○3-Unknown cause
2. New-onset postoperative cerebral infarction
Yes ○No ○
First event date:
Date:
Year
Month
Day,
Hour
Minute (24-hour format)
Infarction location______________
Infarction area______________

Did it cause corresponding symptoms? ○1 -No
○2 -Yes If yes: Please describe
symptoms
3. Re-bleeding
Time
hours
minutes (24-hour format)
3.1 Completed cranial imaging studies: □1CT □2MRI
3.2 Type and location
Subdural hematoma: Left
Right
Bilateral
Subpial
Epidural hematoma: Left
Right
Bilateral
Subdural;
Intracerebral hematoma: Left
Right
Bilateral
Subtentorial
Subarachnoid hemorrhage: Basal cistern
Lateral fissure
Interpeduncular cistern
Others
Ventricular hemorrhage: Left ventricle
Right ventricle
Third ventricle
Fourth
ventricle
Does it cause corresponding symptoms? ○1 -No
○2 -Yes If yes: Please
describe the symptoms
Has it penetrated the ventricle? ○1 -No
○2 -Yes
Does it rupture into the subarachnoid space: ○1 -No
○2 -Yes
Midline shift: ○1 -No
○2 -Yes
Brain herniation: ○1 -No
○2 -Yes
4. CoagulationAbnormalities
Time
hours
minutes (24-hour format)
4.1 Abnormal Coagulation Markers: □1 -PT ○1 -Elevated
○2 -Decreased;
□2 - INR ○1 -Elevated
○2 -Decreased;
□3 - APTT ○1 - Elevated
○2 - Decreased;
□4 - Fbg ○1 -
Elevated
○2 - Decreased;
□5 - TT ○1 - Elevated
○2 - Decreased;
□6 - FDP ○1
- Elevated
○2 - Decreased;
□7 - DD ○1 - Elevated
○2 - Decreased

5.AbnormalAbsolute Platelet Count
Time
Hours
Minutes (24-hour
format)
5.1 Absolute Platelet Count:
10^9/L
6. Bleeding from various organs
Time
hours
minutes (24-hour format)
6.1 Site of bleeding: □1 - Digestive tract
□2 - Respiratory tract
□3 - Urinary
tract
□4 - Other organs
□5 - Other
□6 - Unknown
7. Abnormal Liver Function
Time
Hours
Minutes (24-hour format)
8. Renal Function Abnormalities
Time
Hours
Minutes (24-hour format)
9. Infection
Time
Hours
Minutes (24-hour format)
Site of Infection: □1 - Gastrointestinal Tract
□2 - Respiratory Tract
□3 -
Urinary System
□4 - Other
□5 - Unknown
10. Myocardial infarction
Time
Hours
Minutes (24-hour format)
11. Lower Extremity Venous Thrombosis
Time
hours
minutes (24-hour
format)
12. Pulmonary embolism
Time
Hours
Minutes (24-hour format)
13. Hyperlipidemia
Time
Hours
Minutes (24-hour format)
14. Bradycardia
Time
H
M (24-hour format)
15. Rash/Drug Allergy
Time
H
M (24-hour format)
16. Diarrhea
Time
hours
minutes (24-hour format)
17. Hyperglycemia
Time
Hours
Minutes (24-hour format)
18. Other
Name: ________________;
Time
:
(24-hour format)
D3
Clinical Examination
Physical Examination:
3.1 Heart rate:
beats/min
3.2 Pulse rate:
beats/min
3.3 Systolic Blood Pressure 1 (Supine Position, Systolic Reading):
/
mmHg
Systolic Blood Pressure 2 (Supine Position, Systolic Reading):
/
mmHg Diastolic Blood Pressure 1 (Supine Position, Systolic Reading):
/

mmHg Diastolic Blood Pressure 2 (supine position, systolic measurement):
/
mmHg
3.4
Highest respiratory rate within 24 hours:
breaths/min
Highest body temperature within 24 hours:
.
°C
Sputum characteristics:
purulent sputum
clear sputum
no sputum
Cough:
Yes
No
Shortness of breath (wheezing, labored breathing):
Yes
No
Lung auscultation:
Rales
Wet rales
Bronchial breath sounds
Other:__ _;
Nasal endotracheal intubation:
Yes
No
Endotracheal intubation:
Yes
No
Date of intubation: Date
Year
Month
Day, Time
Hours
Minutes
Ventilator-assisted ventilation:
Yes
No
Ventilator-assisted ventilation start time: Date
Year
Month
Day, Time
Hour
Minute
Ventilator oxygen concentration fraction (FiO₂ = 0.21 + oxygen flow rate / 25):
.
%
Arterial blood gas partial pressure of oxygen (PaO₂):
.
mmHg
Clinical Score
3.5 NIHSS Score: [Range0-42Points; higher scores indicate more severe neurological impairment]
○0-1 points: Normal or near-normal;
○1–4 points: Mild stroke/mini-stroke;
○5–15 points: Moderate stroke;
○16–20: Moderate-to-severe stroke;
○21–42: Severe stroke.
3.6 mRS Score [Note: Scored based on condition at the time of this visit]
○0= Completely asymptomatic;
○1 = Symptoms present but no significant disability: Able to perform all previously
engaged duties and activities;
○2 = Mild disability: Unable to perform all previously engaged activities, but can
manage personal affairs without assistance;

○3 = Moderate disability: Requires some assistance, but can walk without help;
○4 = Severe disability: Unable to walk without assistance and unable to care for
personal bodily needs;
○5=Severe disability: Bedridden, incontinent, requiring constant nursing and care.
D4 Imaging Studies
D4.1 Postoperative cranial CT or MRI scan
Date:
Year:
Month:
Day:
Time:
Type of Infarction and Recovery Status
Ischaemic Type: √Complete anterior circulation ischaemia √Partial
anterior circulation ischaemia √Posterior circulation ischaemia √Focal ischaemia
Recovery Level: Infarct shrinkage or disappearance 口Yes 口No
Cerebral Function Recovery: mRS Score Improvement 口Yes 口No
[Note: 1. Complete anterior circulation infarction: Manifested as triad symptoms, i.e., complete
middle cerebral artery syndrome; Higher-level cerebral dysfunction (consciousness disturbance,
aphasia, acalculia, spatial disorientation, etc.); homonymous hemianopia, and severe motor and/or
sensory deficits in three contralateral areas (face, upper limb, lower limb). Most cases involve
occlusion of the proximal trunk of the middle cerebral artery, with a minority caused by occlusion
of the internal carotid artery siphon segment, resulting in extensive cerebral infarction. 2. Partial
anterior circulation infarction: Presents with two of the above triad features, or solely higher-level
neurological impairment, or sensory-motor deficits more localized than in complete anterior
circulation infarction. Indicates infarction in the distal trunk, branches, or small-to-medium
vessels of the middle cerebral artery, or occlusion of branches associated with anticardiolipin
antibodies. 3. Posterior circulation infarction: Manifested as vertebrobasilar syndrome of varying
severity; may present as ipsilateral cranial nerve palsy with contralateral sensory-motor deficits;
bilateral sensory-motor deficits; binocular coordination and cerebellar dysfunction without long
tract signs or visual field defects. Caused by occlusion of the vertebral-basilar arteries and their
branches, resulting in brainstem and cerebellar infarcts of varying sizes. 4. Lacunar infarction:
Manifested as lacunar syndrome, such as pure motor hemiparesis, pure sensory stroke, ataxic
hemiparesis, or clumsy hand-dysarthria syndrome. Most cases involve small lacunar lesions
caused by lesions in the basal ganglia or small perforating vessels of the pons.
D4.2 Postoperative Assessment of Revascularization
Is the surgical site patent? Yes
No
Assess the degree of cervical vascular stenosis via CTA, MRA, DSA, and US (Mild
; Moderate
;
Severe
; Total occlusion
)
D4.3 Repeat chest CT scan without contrast

1. Follow-up chest CT scan
Date:
Year
Month
Day, Time:
Hour
Minute
(24-hour format)
2 Presence of shadows, infiltrates, or cavities: ○1 - No
○2 - Yes
3Location of lesion:
□1 - Left upper lobe
□2 - Left lower lobe
□3 - Right upper lobe
□4 - Right middle lobe
□5 - Right lower lobe
4 Lesion cross-section Length
.
cm
Width
.
cm
Number of layers
.
layers
Layer thickness
.
cm
Lesion Volume
.
cm³/ml
5. Has the lesion enlarged since the previous scan? (Not applicable for initial
chest CT):
○1 - No
○2 - Yes
6. Is there pleural effusion associated with the lesion?
○1 -No
○2 -Yes
4.4 Laboratory Tests
Blood draw date:
Year
Month
Day
Time:
Hour
Minute (24-hour
format)
Visits:
WBC - White Blood Cell
PSA-Prostate-Specific
LYMPH# - Absolute
PCA - Protein C activity
MONO# - Absolute
NT-proBNP - N-terminal
NEUT# - Neutrophil
cTnI-Cardiac Troponin I
EO# - Eosinophil Absolute
MYO-Myoglobin
BASO# - Basophil
AST
-
Aspartate
PLT-Platelet Count
ALT
-
Alanine
PDW-Platelet Distribution
AST/ALT

Visits:
MPV - Mean Platelet
TP-Total Protein
P-LCR-Large Platelet
ALB-Albumin
PCT - Prothrombin Time
GLO - Globulin
RBC-Red Blood Cell
A/G Ratio
HGB - Hemoglobin
TBIL - Total Bilirubin
HCT-Hematocrit
D-BIL - Direct Bilirubin
MCV - Mean Corpuscular
I-BIL - Indirect Bilirubin
MCH - Mean Corpuscular
MCHC - Mean
ALP
-
Alkaline
RDW%-Red Cell
Na - Sodium
PT - Prothrombin Time
CL - Chloride
APTT - Activated Partial
Ca - Calcium
Fib-Fibrinogen level
CO2-Carbon Dioxide
TT-Thrombin Time
Carbon Dioxide Binding
FDP-Fibrin(ogen)
cys-c (cystatin C)
D-D (D-dimer)
BUN-Blood
Urea
TM
Cr-Creatinine
TAT
eGFR (CKD)
PIC
UA-Uric Acid
tPAI-C (tissue-type
UREA-Urea
ATA-Antithrombin III
CK-Creatine Kinase
LDH-Lactate
VB12-Vitamin B12
Folate
TC-Total Cholesterol
R (R-value)
TG - Triglycerides
Angle-Angle
HDL-C-High-Density
MA-MA Value
LDL-C - Low-Density
CI-CI value
APOA-Apolipoprotein A1
LY30-LY30 value
APOB-Apolipoprotein B
EPL-EPL value

Visits:
Lp(a) - Lipoprotein(a)
PAI-1 (PAI-1 rs1799889
HCY-Homocysteine
CYP2C19 (Clopidogrel)
HbA1c - Glycated
APOE
(ApoE
gene
GLU - Fasting Blood
ABO
CRP - C-reactive protein
D5 Concomitant Medications
D5.1 Please complete concomitant medications
Schedule Next Visit: 90days post-surgery
Visit 4 Completed Physician Signature: ________________
Signature Date:
-
-

Visit 5: 90 ± 2 days post-op
You must complete the following by 90 ± 2 days post-surgery:
E1. Visit Date
E2. Adverse Events
E3. Clinical Examination
E4. Imaging Studies
E5. Concomitant Medications

E1
Visit Date
1. Visit Date
E2 Adverse Events
2.1 Have any adverse events occurred since enrollment?
○1 -No
○2 -Yes
If "No" is selected, proceed directly to Section E3.
2.2
If an adverse event occurred, please select:
In the event of any adverse event/serious adverse event, please complete the Adverse
Event/Serious Adverse Event Report Form (see attachment).
1. Date of death
, Time
(24-hour format)
Cause of Death:
○1-Vascular Cause of Death
○1 - Death due to ischemic stroke
○2 - Death from hemorrhagic stroke
○3 - Sudden cardiac death
○4 - Death from Acute Myocardial Infarction
○5 - Death from congestive heart failure
○6 - Pulmonary embolism
○7 - Death from cardiovascular/cerebrovascular intervention or surgery (unrelated
to acute myocardial infarction)
○8 - Other vascular-related deaths
○2-Non-vascular cause death
○3-Unknown cause
2. New-onset postoperative cerebral infarction
Yes ○No ○
First event date:
Date:
Year
Month
Day,
Hour
Minute (24-hour format)
Infarction location______________
Infarction area______________

Does it cause corresponding symptoms? ○1 -No
○2 -Yes If yes: Please describe
symptoms
3. Re-bleeding
Time
hours
minutes (24-hour format)
3.1 Cranial Imaging Completed: □1- CT □2- MRI
3.2 Type and location
Subdural hematoma: Left
Right
Bilateral
Subpial
Epidural hematoma: Left
Right
Bilateral
Subdural;
Intracerebral hematoma: Left
Right
Bilateral
Subtentorial
Subarachnoid hemorrhage: Basal cistern
Lateral fissure
Interpeduncular cistern
Others
Ventricular hemorrhage: Left ventricle
Right ventricle
Third ventricle
Fourth
ventricle
Does it cause corresponding symptoms? ○1 -No
○2 -Yes If yes: Please
describe the symptoms
Has it penetrated the ventricles: ○1 -No
○2 -Yes
Does it rupture into the subarachnoid space: ○1 -No
○2 -Yes
Midline shift: ○1 -No
○2 -Yes
Brain herniation: ○1 -No
○2 -Yes
4. CoagulationAbnormalities
Time
Hours
Minutes (24-hour format)
4.1 Abnormal Coagulation Markers:
□1 -PT ○1 -Elevated
○2 -Decreased;
□2 - INR ○1 -Elevated
○2 -Decreased;
□3 - APTT ○1 - Elevated
○2 - Decreased;
□4 - Fbg ○1 - Elevated
○2 - Decreased;
□5 - TT ○1 - Elevated
○2 - Decreased;
□6 - FDP ○1 - Elevated
○2 - Decreased;

□7 - DD ○1 - Elevated
○2 - Decreased
5.AbnormalAbsolute Platelet Count
Time
hours
minutes (24-hour
format)
5.1 Absolute Platelet Count:
10^9/L
6. Bleeding sites:
Time:
hours
minutes (24-hour format)
6.1 Bleeding site: □1- Gastrointestinal tract
□2- Respiratory tract
□3-
Urinary tract
□4- Other organs □5- Other
□6 - Unknown
7. Abnormal Liver Function
Time
Hours
Minutes (24-hour format)
8. Renal Function Abnormalities
Time
Hours
Minutes (24-hour format)
9. Infection
Time
Hours
Minutes (24-hour format)
Site of Infection: □1 - Gastrointestinal Tract
□2 - Respiratory Tract
□3 -
Urinary System
□4- Other
□5- Unknown
10. Myocardial infarction
Time
Hours
Minutes (24-hour format)
11. Lower Extremity Venous Thrombosis
Time
hours
minutes (24-hour
format)
12. Pulmonary embolism
Time
Hours
Minutes (24-hour format)
13. Hyperlipidemia
Time
Hours
Minutes (24-hour format)
14. Bradycardia
Time
H
M (24-hour format)
15. Rash/Drug Allergy
Time
H
M (24-hour format)
16. Diarrhea
Time
hours
minutes (24-hour format)
17. Hyperglycemia
Time
Hours
Minutes (24-hour format)
18. Other
Name: ________________;
Time
:
(24-hour format)
E3
Clinical Examination
Physical Examination:
3.1 Heart rate:
beats/min
3.2 Pulse rate:
beats/min
3.3 Systolic Blood Pressure 1 (Supine Position, Systolic Reading):
/
mmHg
Systolic Blood Pressure 2 (Supine Position, Systolic Reading):
/
mmHg Diastolic Blood Pressure 1 (Supine Position, Systolic Reading):
/

mmHg Diastolic Blood Pressure 2 (supine position, systolic measurement):
/
mmHg
3.4
Highest respiratory rate within 24 hours:
breaths/min
Highest body temperature within 24 hours:
.
°C
Sputum characteristics:
purulent sputum
clear sputum
no sputum
Cough:
Yes
No
Shortness of breath (wheezing, labored breathing):
Yes
No
Lung auscultation:
Rales
Wet rales
Bronchial breath sounds
Other:__ _;
Nasal endotracheal intubation:
Yes
No
Endotracheal intubation:
Yes
No
Date of intubation: Date
Year
Month
Day, Time
Hours
Minutes
Ventilator-assisted ventilation:
Yes
No
Ventilator-assisted ventilation start time: Date
Year
Month
Day, Time
Hour
Minute
Ventilator oxygen concentration fraction (FiO₂ = 0.21 + oxygen flow rate / 25):
.
%
Arterial blood gas partial pressure of oxygen (PaO₂):
.
mmHg
Clinical Score
3.5
NIHSS score: [Range0-42Points; higher scores indicate more severe neurological impairment]
○0-1 points: Normal or near-normal;
○1–4 points: Mild stroke/mini-stroke;
○5–15 points: Moderate stroke;
○16–20: Moderate-to-severe stroke;
○21-42: Severe stroke.
3.6
mRS Score [Note: Score based on condition at the time of this visit]
○0=Completely asymptomatic;
○1=No significant disability despite symptoms: Able to perform all duties and activities
previously undertaken;

○2 = Mild disability: Unable to perform all previously undertaken activities, but able to
manage personal affairs without assistance;
○3 = Moderate disability: Requires some assistance, but does not need help walking;
○4=Severe disability: Unable to walk without assistance and unable to care for personal
bodily needs;
○5=Severe disability: Bedridden, incontinent, requiring constant nursing and care.
E4 Imaging Studies
4.1 Postoperative Cranial CT or MRI
Date:
Year:
Month:
Day:
Time:
Ischaemic Type and Recovery Status
Ischaemic Type: √Complete anterior circulation ischaemia √Partial
anterior circulation ischaemia √Posterior circulation ischaemia √Focal ischaemia
Recovery Level: Infarct shrinkage or disappearance 口Yes 口No
Cerebral Function Recovery: mRS Score Improvement 口Yes 口No
[Note: 1. Complete anterior circulation infarction: Manifested as triad symptoms, i.e., complete
middle cerebral artery syndrome; Higher-level cerebral dysfunction (consciousness disturbance,
aphasia, acalculia, spatial disorientation, etc.); homonymous hemianopia, and severe motor and/or
sensory deficits in three contralateral areas (face, upper limb, lower limb). Most cases involve
occlusion of the proximal trunk of the middle cerebral artery, with a minority caused by occlusion
of the internal carotid artery siphon segment, resulting in extensive cerebral infarction. 2. Partial
anterior circulation infarction: Presents with two of the above triad features, or solely higher-level
neurological impairment, or sensory-motor deficits more localized than in complete anterior
circulation infarction. Indicates infarction in the distal trunk, branches, or small-to-medium
vessels of the middle cerebral artery, or occlusion of branches associated with anticardiolipin
antibodies. 3. Posterior circulation infarction: Manifested as vertebrobasilar syndrome of varying
severity; may present as ipsilateral cranial nerve palsy with contralateral sensory-motor deficits;
bilateral sensory-motor deficits; binocular coordination and cerebellar dysfunction without long
tract signs or visual field defects. Caused by occlusion of the vertebral-basilar arteries and their
branches, resulting in brainstem and cerebellar infarcts of varying sizes. 4. Lacunar infarction:
Manifested as lacunar syndrome, such as pure motor hemiparesis, pure sensory stroke, ataxic
hemiparesis, or clumsy hand-dysarthria syndrome. Most cases involve small lacunar lesions
caused by lesions in the basal ganglia or small perforating vessels of the pons.
4.2 Postoperative Assessment of Revascularization
Is the surgical site patent? Yes
No
Determination of cervical vascular stenosis severity via CTA, MRA, DSA, or US

(Mild
; Moderate
;
Severe
; Total occlusion
)
4.3 Follow-up Chest CT Scan
B4.2.1 Follow-up Chest CT Scan
Date
, Time
(24-hour format)
B4.2.2 Presence of shadows, infiltration, or cavities: ○1 -No
○2 -Yes
B4.2.3 Location of lesion:
□1 - Left upper lobe
□2 - Left lower lobe
□3 - Right upper lobe
□4 - Right middle lobe
□5 - Right lower lobe
B4.2.4 Lesion cross-section Length
.
cm
Width
.
cm
Number of layers
.
layers
Layer
thickness
.
cm
Lesion volume
.
cm³/ml
B4.2.5 Has the lesion enlarged since the previous examination? (This item may
be left blank for the initial chest CT): ○1 - No
○2 - Yes
B4.2.6 Is the lesion associated with pleural effusion? ○1- No
○2- Yes
4.4 Laboratory Tests
Blood draw date:
Year
Month
Day
Time:
Hour
Minute (24-hour format)
Visits:
WBC - White Blood Cell
PSA-Prostate-Specific
LYMPH# - Absolute
PCA - Protein C activity
MONO# - Absolute
NT-proBNP - N-terminal
NEUT# - Neutrophil
cTnI-Cardiac Troponin I
EO# - Eosinophil Absolute
MYO-Myoglobin
BASO# - Basophil
AST
-
Aspartate
PLT-Platelet Count
ALT
-
Alanine
PDW-Platelet Distribution
AST/ALT

Visits:
MPV - Mean Platelet
TP - Total Protein
P-LCR-Large Platelet
ALB-Albumin
PCT - Prothrombin Time
GLO - Globulin
RBC-Red Blood Cell
A/G Ratio
HGB - Hemoglobin
TBIL - Total Bilirubin
HCT-Hematocrit
D-BIL - Direct Bilirubin
MCV - Mean Corpuscular
I-BIL-Indirect Bilirubin
MCH - Mean Corpuscular
MCHC - Mean
ALP
-
Alkaline
RDW%-Red Cell
Na - Sodium
PT - Prothrombin Time
CL - Chloride
APTT - Activated Partial
Ca - Calcium
Fib-Fibrinogen level
CO2-Carbon Dioxide
TT-Thrombin Time
Carbon Dioxide Binding
FDP-Fibrin(ogen)
cys-c (cystatin C)
D-D (D-dimer)
BUN-Blood
Urea
TM
Cr-Creatinine
TAT
eGFR (CKD)
PIC
UA-Uric Acid
tPAI-C (tissue-type
UREA-Urea
ATA-Antithrombin III
CK-Creatine Kinase
LDH-Lactate
VB12-Vitamin B12
Folate
TC-Total Cholesterol
R (R-value)
TG - Triglycerides
Angle-Angle
HDL-C-High-Density
MA-MA Value
LDL-C - Low-Density
CI-CI value
APOA-Apolipoprotein A1
LY30-LY30 value
APOB-Apolipoprotein B
EPL-EPL value

Visits:
Lp(a) - Lipoprotein(a)
PAI-1 (PAI-1 rs1799889
HCY-Homocysteine
CYP2C19 (Clopidogrel)
HbA1c - Glycated
APOE
(ApoE
gene
GLU - Fasting Blood
ABO
CRP - C-reactive protein
E5 Combination Medication
E5.1 Please complete combination therapy
Visit 5 Completed Physician Signature: ________________
Signature Date:

Combination Medication Chart
Generic
Name
Brand
Name
Dosage
Administration
Frequency
Route of Administration
Start
Time
End
Time
Remarks
Quantity
Unit
○1
Anti-hypertensive
drugs
○μg
○mg
○g
○ml
○bag
○tablet
○Other:
○QD
○BID
○TID
○QOD
○1 time/week
○Q8h
○Other:
○Oral
○IM
○IV injection
○IV infusion
○Subcutaneous injection
○Topical
○Other
_____Year
____Month
______Day
_____Year
____Month
______Day
○μg
○mg
○g
○ml
○bags
○tablet
○Other:
○QD
○BID
○TID
○QOD
○Once per
week
○Q8h
○Other:
○Oral
○Intramuscular injection
○Intravenous injection
○IV infusion
○Subcutaneous injection
○Topical
○Other
_____Year
____Month
______Day
_____Year
____Month
______Day
○μg
○mg
○g
○ml
○bags
○tablet
○Other:
○QD
○BID
○TID
○QOD
○1 time/week
○Q8h
○Other:
○Oral
○IM
○IV injection
○IV infusion
○Subcutaneous injection
○Topical
○Other
_____Year
____Month
______Day
_____Year
____Month
______Day
○2 Anti-diabetic
drugs
○µg
○mg
○g
○ml
○bag
○tablet
○Other:
○QD
○BID
○TID
○QOD
○Once per
week
○Q8h
○Other:
○Oral
○Intramuscular injection
○Intravenous injection
○IV infusion
○Subcutaneous injection
○Topical
○Other
_____Year
____Month
______Day
_____Year
____Month
______Day
○μg
○mg
○g
○ml
○bags
○tablet
○Other:
○QD
○BID
○TID
○QOD
○1 time/week
○Q8h
○Other:
○Oral
○IM
○IV injection
○IV infusion
○Subcutaneous injection
○Topical
○Other
_____Year
____Month
______Day
_____Year
____Month
______Day
○μg
○mg
○g
○ml
○bags
○tablet
○Other:
○QD
○BID
○TID
○QOD
○1 time/week
○Q8h
○Other:
○Oral
○Intramuscular injection
○Intravenous injection
○Intravenous infusion
○Subcutaneous injection
○Topical
○Other
_____Year
____Month
______Day
_____Year
____Month
______Day
○3 Lipid-regulating
drugs
○µg
○mg
○g
○ml
○bag
○tablet
○Other:
○QD
○BID
○TID
○QOD
○1 time/week
○Q8h
○Other:
○Oral
○IM
○IV injection
○IV infusion
○Subcutaneous injection
○Topical
○Other
_____Year
____Month
______Day
_____Year
____Month
______Day

○μg
○mg
○g
○ml
○bags
○tablet
○Other:
○QD
○BID
○TID
○QOD
○1 time/week
○Q8h
○Other:
○Oral
○Intramuscular injection
○Intravenous injection
○Intravenous infusion
○Subcutaneous injection
○Topical
○Other
_____Year
____Month
______Day
_____Year
____Month
______Day
○4 Anti-platelet
Agents
○µg
○mg
○g
○ml
○bag
○tablet
○Other:
○QD
○BID
○TID
○QOD
○1 time/week
○Q8h
○Other:
○Oral
○IM
○IV injection
○IV infusion
○Subcutaneous injection
○Topical
○Other
_____Year
____Month
______Day
_____Year
____Month
______Day
○μg
○mg
○g
○ml
○bags
○tablet
○Other:
○QD
○BID
○TID
○QOD
○1 time/week
○Q8h
○Other:
○Oral
○Intramuscular injection
○Intravenous injection
○Intravenous infusion
○Subcutaneous injection
○Topical
○Other
_____Year
____Month
______Day
_____Year
____Month
______Day
○5 Anticoagulants
○µg
○mg
○g
○ml
○bag
○tablet
○Other:
○QD
○BID
○TID
○QOD
○1 time/week
○Q8h
○Other:
○Oral
○IM
○IV injection
○IV infusion
○Subcutaneous injection
○Topical
○Other
_____Year
____Month
______Day
_____Year
____Month
______Day
○μg
○mg
○g
○ml
○bags
○tablet
○Other:
○QD
○BID
○TID
○QOD
○1 time/week
○Q8h
○Other:
○Oral
○Intramuscular injection
○Intravenous injection
○Intravenous infusion
○Subcutaneous injection
○Topical
○Other
_____Year
____Month
______Day
_____Year
____Month
______Day
○6 Traditional
Chinese Medicines
○µg
○mg
○g
○ml
○bag
○tablet
○Other:
○QD
○BID
○TID
○QOD
○Once per
week
○Q8h
○Other:
○Oral
○IM
○IV injection
○IV infusion
○Subcutaneous injection
○Topical
○Other
_____Year
____Month
______Day
_____Year
____Month
______Day
○μg
○mg
○g
○ml
○bags
○tablet
○Other:
○QD
○BID
○TID
○QOD
○1 time/week
○Q8h
○Other:
○Oral
○Intramuscular injection
○Intravenous injection
○Intravenous infusion
○Subcutaneous injection
○Topical
○Other
_____Year
____Month
______Day
_____Year
____Month
______Day
○7 Other
medications
○µg
○mg
○g
○ml
○bag
○tablet
○Other:
○QD
○BID
○TID
○QOD
○1 time/week
○Q8h
○Other:
○Oral
○IM
○IV injection
○IV infusion
○Subcutaneous injection
○Topical
○Other
_____Year
____Month
______Day
_____Year
____Month
______Day

○μg
○mg
○g
○ml
○bags
○tablet
○Other:
○QD
○BID
○TID
○QOD
○1 time/week
○Q8h
○Other:
○Oral
○Intramuscular injection
○Intravenous injection
○Intravenous infusion
○Subcutaneous injection
○Topical
○Other
_____Year
____Month
______Day
_____Year
____Month
______Day
○μg
○mg
○g
○ml
○bags
○tablet
○Other:
○QD
○BID
○TID
○QOD
○1 time/week
○Q8h
○Other:
○Oral
○IM
○IV injection
○IV infusion
○Subcutaneous injection
○Topical
○Other
_____Year
____Month
______Day
_____Year
____Month
______Day
○μg
○mg
○g
○ml
○bags
○tablet
○Other:
○QD
○BID
○TID
○QOD
○1 time/week
○Q8h
○Other:
○Oral
○Intramuscular injection
○Intravenous injection
○Intravenous infusion
○Subcutaneous injection
○Topical
○Other
_____Year
____Month
______Day
_____Year
____Month
______Day
○μg
○mg
○g
○ml
○bags
○tablet
○Other:
○QD
○BID
○TID
○QOD
○1 time/week
○Q8h
○Other:
○Oral
○IM
○IV injection
○IV infusion
○Subcutaneous injection
○Topical
○Other
_____Year
____Month
______Day
_____Year
____Month
______Day

Adverse Event Record Form
Please enter adverse events according to the codes provided below *. If no code exists, directly enter the
adverse event name (using standard medical terminology in block letters). Record one adverse event per
column; mark "√" in the corresponding "○" box.
Name
Start Date
________Year______Month
_______Day
________Year______Month_
______Day
________Year______Month_
______Day
End Date
________Year______Month
_______Day
OR ○Continues to exist
________Year______Month_
______Day
OR ○Continues to exist
________Year______Month_
______Day
OR ○Continues to exist
Severity
○1
○2
○3
○4
○5
○1
○2
○3
○4
○5
○1
○2
○3
○4
○5
Potentially
Related
Diseases or
Medications
Relevance
Assessment
○1
Definitely related
○2
Highly likely
○3
Possibly related
○4
Likely unrelated
○5
Not related
○1
Definitely relevant
○2
Very likely related
○3
Possibly relevant
○4
May be irrelevant
○5
Not related
○1
Definitely relevant
○2
Very likely related
○3
Possibly relevant
○4
Possibly unrelated
○5
Not relevant
Clinical
Measures
Outcome
○1
Resolution/Recovery
○2
Improvement
○3
Unchanged
○4
Worsened
○5
Unable to track
○6
Other
○1
Resolution/Recovery
○2
Improvement
○3
Unchanged
○4
Worsened
○5
Unable to track
○6
Other
○1 Disappeared/Recovered
○2
Alleviated
○3
Unchanged
○4
Worsened
○5
Unable to track
○6
Other
Severity
Adverse
Event
○1
Yes (Reason)
○2
No
○1
Yes (Reason)
○2
No
○1
Yes (Reason)
○2
No
Remarks