A Real-world Registry Study of Multidisciplinary Collaborative Diagnosis and Treatment Model for Cardioembolic Stroke
Conditions: Cardioembolic Stroke, Multidisciplinary Communication
Sponsor: Xiao Huang

Clinical Research Project Program                                            Version No.: V1.0 Version Date: December 10,2021 
 
 
 
 
 
 
 
 
Clinical study protocol 
Project proposal 
 
Program name:     A real-world registry study of multidisciplinary 
collaborative diagnosis and treatment model for cardioembolic stroke  
 
Program No.:                                                                                      
 
Study type:            A real world registration research 
 
Founding source:  Jiangxi Provincial Department of Science and 
Technology 
 
Version No.:                         V 1.0 
 
Applicant: Xingen Zhu                  Telephone: 13803546020 
 
Unit:  the Second Affiliated Hospital of Nanchang University 
 
Address:   1 Minde Road, Donghu District, Nanchang City, Jiangxi 
Province, China 
 
E-Mail:    zxg2008vip@163.com 
 
Date of applicant:  March 1, 2022 
 
 
 
 
 
 
Clinical Research Center, the Second Affiliated Hospital of Nanchang University

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2Major members of the project should receive GCP training and obtain certificates 
Clinical Research Project Program                                              Version No.: V1.0 Version Date: December 10,2021 
 
1. Main participants of the project 
 
 

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Clinical Research Project Program                                                          Version No.: V1.0 Version Date: December 10,2021 
 
2. Summary of the research Plan (it shall include the research topic, 
research purpose, design type, research object, sample size, selection 
criteria, observation indicators, statistical analysis methods, etc.) 
 
Research title: Real-world registration study of the multidisciplinary cooperative diagnosis 
and treatment mode of cardioembolic stroke 
purpose of research: 
① Main purpose: To establish a multidisciplinary assisted diagnosis and treatment mode 
for patients at high risk of cardioembolic stroke, and to manage and collect the 
diagnosis, treatment and prognosis data of patients; 
② Secondary objectives: To explore the improvement of cardioembolic stroke, 
cardiovascular complex events, recurrent stroke and all-cause death risk, quality of life, 
and cardiac function in the "multidisciplinary assisted diagnosis and treatment mode" 
group and the "routine diagnosis and treatment model group". The conventional 
diagnosis and treatment mode can match the patients not adopted in the same period and 
"multidisciplinary assistance in diagnosis and treatment mode". 
Design type: A non-intervention, prospective, observational, real-world study (at least 1.5 
years). No fixed diagnosis and treatment plan is set up in advance, and only a multidisciplinary 
assisted diagnosis and treatment mode is established. All treatment options are completely made 
by the clinicians who follow the expert consensus of relevant textbooks and clinical guidelines, 
and they are formulated according to the patients' conditions. 
Study subjects: Collect high-risk patients from the Second Affiliated Hospital of Nanchang 
University and various hospitals of Jiangxi Province from September 2022 to September 2023. 
Selection criteria: ① met the high embolic risk (including intracardiac thrombosis, 
intracardiac tumor, aortic atherosclerosis, atrial fibrillation, and spontaneous development of 
ultrasound) in the risk stratification criteria of The Chinese Expert Consensus on Cardiac stroke 
Diagnosis (2020); ② meets the surgical indications for cardiac diseases related to the Chinese 
Expert Consensus on the Treatment of Cardioembolic Stroke (2022) (including left atrial 
fibrillation occlusion, left atrial fibrillation ligation, and radiofrequency ablation of atrial 
fibrillation recommended for high-risk stroke patients with atrial fibrillation; Transcatheter PFO 
occlusion is recommended for cryptogenic stroke patients with high-risk P FO; Valvular repair or 
replacement, etc.); ③ understood and voluntarily signed the informed consent form. 
Exclusion criteria: ① with severe mental disorder and unable to express intention; ② with 
other abnormal signs, laboratory tests and clinical diseases, not suitable to attend investigator; ③ 
and unable to complete long-term follow-up. 
Project objectives and assessment indicators: (a) establish a multidisciplinary cooperative 
diagnosis and treatment mode of cardiovascular and brain joint treatment, and routinely carry out 
interdisciplinary diagnosis and treatment of cardiovascular and cerebrovascular diseases; (b) 
develop an optimized diagnosis and treatment process, reduce treatment links, and save medical 
resources and costs. 
 
 
 

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Diagnosis and Treatment process (Figure 1): 
Primary prevention (mainly for patients with high embolic risk, including valvular heart 
disease/intracardial tumor, thrombosis/atrial fibrillation/infective endocarditis/PFO, with or 
without a history of stroke): 
a) Patients with high risk of embolism, such as valvular heart disease/intracardiac tumors, 
thrombosis/atrial fibrillation/infective endocarditis/PFO, and patients with or without a history 
of stroke, were screened for stroke risk assessment in primary hospitals.  
b) Imaging diagnosis and treatment, such as cardiac color ultrasound, cardiac CTA, foaming test 
(right cardiography), transesophageal ultrasound, right atrial angiography, etc., should be 
developed according to the research needs, and the specialized diagnosis and treatment 
process at the recommended level should be formulated 
c) Health education and follow-up 
 
Secondary prevention (emergency department mainly for patients with new stroke) :  
a) Primary doctors should do a good job in pre-hospital treatment of suspected stroke patients 
and transfer the patients to superior hospitals as soon as possible, so as to quickly identify the 
nature of stroke; Once it is clear that it is ischemic stroke, emergency treatment should be 
carried out according to the diagnosis and treatment process of ischemic stroke.  
b) When patients with sudden neurological deficits enter the emergency room, the stroke 
identification procedure and the treatment process of the stroke center should be initiated 
immediately, mainly using the BEFAST test /FAST test/" stroke 1-2-0 "method;  
c) After the disease stabilized, the examination related to etiological diagnosis should be 
improved (screening for valvular heart disease/intracardiac tumor, thrombosis/atrial 
fibrillation/infective endocarditis/PFO);  
d) Health education norms and follow-up 
Multidisciplinary assisted care model group: Patients who agreed to and accepted the 
recommendation of multidisciplinary assisted care mode were enrolled in the multidisciplinary 
assisted care model group. These patients would undergo further stroke (primary/secondary) 
prevention intervention, as detailed in the MDT flow chart;  
Any of the following treatments (including but not limited to), as recommended by the standard 
medical procedure, shall be deemed to have received the standard medical treatment; otherwise, 
they were not.  
1) Surgical procedures: left atrial appendage ligation, left atrial appendage clip, valve repair or 
replacement, etc.  
2) Medical procedures: atrial fibrillation radiofrequency ablation, valvular closure, left atrial 
appendage closure, PFO closure, etc.  
3) Anticoagulant drug therapy: standardized anticoagulant drug therapy.  

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Routine treatment model group: Patients who did not agree to enter the multidisciplinary 
treatment mode were automatically entered into the routine treatment mode group.  
Study end points:  
Primary end point: Composite end point of cardiovascular and cerebrovascular events (nonfatal 
ischemic stroke, Nonfatal hemorrhagic stroke, Nonfatal myocardial infarction, Nonfatal heart 
failure, and cardiovascular and cerebrovascular death)  
Secondary end points: cardiovascular and cerebrovascular death; All-cause death; Cardiac 
insufficiency; Cognitive dysfunction 
 
 
 

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Clinical Research Project Program                                                            Version No.: V1.0 Version Date: December 10,2021 
3. Research background data 
 
1. Project approval basis 
Stroke, as the first cause of death in China, has the "three high" characteristics of high 
morbidity, high disability rate and high mortality rate. Data show that in the next 20 years, the 
number of stroke patients in China will increase by nearly four times, and the prevention and 
treatment of stroke has a long way to go. In the subtyping of ischemic stroke, the proportion of 
cardiac stroke is approximately 14 – 30%1，2. cardioembolic stroke (CES), hereinafter referred to 
as cardioembolic stroke, refers to the clinical syndrome of emboli from the heart and aortic arch 
through the circulation leading to cerebral artery embolism causing the corresponding cerebral 
dysfunction. The mechanism of cardioembolic stroke is usually summarized into three types: slow 
blood flow (especially cardiac cavity enlargement, atrial loss of contraction function, left 
ventricular wall tumor, etc.) thrombosis and shedding; abnormal valve surface attachments 
(degenerative valve surface calcification, infectious endocarditis, artificial valve surface thrombus, 
etc.); systemic circulation venous system thrombosis through abnormal ventricular channel (atrial 
septal defect or closed orifice) causing embolism (namely "contradictory embolism").CES has 
more related cardiac diseases or risk factors, among which about 70% are caused by atrial 
fibrillation (atrial fibrillation, AF). In recent years, the prevention and treatment of CES (such as 
stroke high-risk AF) has improved1. However, there are still some problems, such as insufficient 
understanding and large differences in treatment strategies. Compared with stroke from other 
causes, the cardiac stroke course is rapidly progressive, with more extensive involvement, 
associated with more severe complications, and a higher incidence of adverse outcomes3. How to 
effectively prevent cardioembolic stroke and improve patient prognosis is a major dilemma in 
clinical practice. 
The formulation and effective implementation of accurate treatment plan to improve the prognosis 
of cardioembolic stroke patients and stroke recurrence is an important means to prevent the onset 
of patients. Compared with other causes of stroke, the cause of cardiac stroke is clear and mostly 
preventable and treatable (e. g., an observational study of elderly patients with heart disease history 
(with AF history) assessing the risk of postoperative thromboembolic complications of LAA 
occlusion combined with cardiac surgery. The results showed significant reductions in uncorrected 
thromboembolism readmission rates (4.2% versus 6.2%), all-cause mortality (17.3% versus 
23.9%), and the composite endpoint (20.5% versus 28.7%) when compared with those without 
LAA occlusion4. The same study in Asians showed that for high-risk PFO (atrial septal aneurysm, 
ASA), high activity, primary and secondary spacing 2 mm], PFO occlusion significantly reduced 

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the main endpoint (stroke, vascular death, thrombolysis defined primary hemorrhage) and stroke 
recurrence (n=120)5. But currently for the prevention and control of cardiac stroke heart brain 
barriers, diagnosis and treatment process specification, related surgical instruments clinical 
application is still in the primary stage, such as severe problems, precision treatment need to 
optimize the current diagnosis and treatment process and professional technology, and an urgent 
need to "brain", this project plans to explore the above scientific problems, in order to guide the 
clinical prevention and treatment of cardiac stroke. To explore the multidisciplinary cooperative 
diagnosis and treatment mode of cardioembolic stroke, and to explore the prevention and treatment 
mode of "screening, prevention, diagnosis and treatment" of provincial, municipal and county 
hospitals with the help of medical association and network. This study combined with existing 
consensus guidelines to develop treatment options based on CES risk stratification and specific 
pathogenesis6,7. Corresponding therapeutic measures are taken to address the different causes of 
CES to prevent the occurrence of stroke and to actively conduct neurorehabilitation treatment. 
Many cardioembolic strokes occur every year in China, and most of the cardiology department 
treat patients with atrial fibrillation without stroke. Many patients with high-risk CES usually 
improve anticoagulation and other symptomatic treatment in the neurology department, but have 
no further systematic investigation of whether it is "cardiac". Many neurologists do not routinely 
consider cardiac treatment in patients with cardioembolic stroke. Therefore, there is an urgent need 
for "heart and brain joint governance". For patients with previous stroke, the risk of recurrent 
stroke is very high if the cause of cardiac thrombosis is not addressed. There are problems in the 
domestic diagnosis and treatment mode, and the heart, surgery, surgery and nerve surgery are not 
effectively integrated. In the past two years, relevant domestic societies have issued the guidelines 
for the prevention and treatment of cardiac stroke (2019) and the Chinese expert consensus on the 
diagnosis of cardiac stroke (2020)8,9. According to the clinical and imaging characteristics of 
cardioembolic stroke, apply the preliminary assessment and risk assessment process of 
cardioembolic stroke (Figure 1): improve cerebral cerebrovascular imaging; 12-lead ECG and 
dynamic electrocardiogram; transthoracic echocardiography; laboratory examination and other 
related examinations, and find possible abnormalities. For example: After admission to the 
neurology department, the patient is routinely screened for atrial fibrillation by completing a 
general ECG and an ambulatory ECG. If atrial fibrillation is present, there is a high risk of 
cardioembolic stroke and referral to the cardiology department is required. Further investigation by 
the cardiology department confirms the presence of thrombus in the atria, and treatment plans are 
developed and evaluated accordingly. The risk factors are addressed through standardized 

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treatment. Regular follow-up after treatment, the incidence of stroke at the primary endpoint, 
neurological function, cardiac function and cardiac electrophysiological assessment, etc. 
Cardiac stroke is characterized by high incidence, difficult treatment and poor prognosis. The 
best treatment is the early screening of people at high risk of such diseases to treat related 
underlying cardiac diseases and high-risk factors. Therefore, relying on the discipline construction, 
we start the multi-disciplinary cooperation and integrate the heart-brain advantage resources team 
to jointly create a new era of "heart-brain joint governance". 
Reference  
1. Lin SP, Long Y, Chen XH, et al. STAF score is a new simple approach for diagnosing 
cardioembolic stroke.Int J Neurosci.2017 Mar;127(3):261–266. 
2. Marnane M, Duggan CA, Sheehan OC, et al.Stroke subtype classification to mechanism-
specific and undetermined categories by TOAST, A-S-C-O, and causative classification system: 
direct comparison in the North Dublin population stroke study.Stroke.2010 Aug;41(8):1579–1586. 
3. Vahanian A, Alfieri O, Andreotti F, et al.Guidelines on the management of valvular heart 
disease (version 2012): the Joint Task Force on the Management of Valvular Heart Disease of the 
European Society of Cardiology (ESC) and the European Association for Cardio-Thoracic Surgery 
(EACTS).Eur J Cardio thorac Surg.2012 Oct;42(4):S1–44. 
4. Friedman DJ, Piccini JP, Wang T, et al.Association between left atrial appendage occlusion 
and readmission for thromboembolism among patients with atrial fibrillation undergoing 
concomitant cardiac surgery[J].JAMA, 2018, 319(4):365374.- 
5. Lee PH, Song JK, Kim JS, et al.Cryptogenic stroke and high risk patent foramen ovale: the 
DEFENSE PFO trial[J].J Am Coll Cardiol, 2018, 71(20):23352342.--- 
6. MacDougall NJ, Amarasinghe S, Muir KW.Secondary prevention of stroke.Expert Rev 
Cardiovasc Ther.2009 Sep;7(9):1103–1115. 
7. Khoo CW, Lip GY.Clinical outcomes of acute stroke patients with atrial fibrillation.Expert 
Rev Cardiovasc Ther.2009 Apr;7(4):371–374. 
8. Geriatric Neurology Group of Geriatric Medicine Branch of Chinese Medical Association, 
Chinese Expert Consensus writing group of cardioembolic stroke diagnosis. The Chinese Expert 
Consensus on the Diagnosis of Cardiac Stroke (2020) [J]. The Chinese Journal of Geriatric 
Medicine.2020,39 (12):1369-1378. 
9. Heart Rhythology professional Committee of Chinese Medical Association, Heart 
Electrophysiology and Pacing Branch of Chinese Medical Association. Guidelines for the 
Prevention and Treatment of Cardioembolic Stroke in China (2019). The Chinese Journal of 
Arrhythmia.2019,(06):463-484. 
 

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Clinical Research Project Program                                                        Version No.: V1.0 Version Date: December 10,2021 
4. Research purpose 
 
1. Research purpose: 
Establish multidisciplinary collaboration diagnosis and treatment mode, standardize the 
diagnosis and treatment process: through the integration of neurosurgery, cardiac vascular 
surgery, neurology, cardiovascular medicine and other related disciplines, build "heart and brain 
treatment" multidisciplinary close cooperation system, standardize integration process and 
diagnosis and treatment, at the same time actively innovation relying on the relevant academic 
society construction, earnestly implement the multidisciplinary collaboration diagnosis and 
treatment mode. Based on the Internet + 5G medical model technology system and information 
platform, research to establish coverage relying on the remote medical service platform, the 
provincial, city and county center of information classification management system, by 
perfecting the regional collaborative emergency medical platform, improve the province 
cardiovascular disease acute critical patients overall treatment level, contribute to the 
standardization of cardiovascular stroke high-risk patients diagnosis and treatment and 
management. Patients with difficult and acute and critical cardiovascular and cerebrovascular 
diseases in the stable rehabilitation period after emergency treatment were transferred back to the 
primary hospital for rehabilitation, follow-up and chronic disease management and treatment. 
2. Study observation endpoint 
(1) Main observation endpoint: composite end point of cardiovascular and cerebrovascular 
events (non-fatal ischemic stroke, non-fatal hemorrhagic stroke, non-fatal myocardial 
infarction, non-fatal heart failure, cardiovascular and cerebrovascular death) 
(2) secondary observation endpoint: cardiovascular and cerebrovascular death; all-cause 
death; cardiac insufficiency; cognitive dysfunction 
 
 

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Clinical Research Project Program                                                        Version No.: V1.0 Version Date: December 10,2021 
5. Study design 
 

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1. Study site and study population 
Collect high-risk patients from the Second Affiliated Hospital of Nanchang University and 
various hospitals of Jiangxi Province from September 2022 to September 2023. 
Selection criteria: ① met the high embolic risk (including Valvular heart 
disease/intracardiac neoplasms, thrombosis/atrial fibrillation/infective endocarditis/PFO) in the risk 
stratification criteria of The Chinese Expert Consensus on Cardiac stroke Diagnosis (2020); ② 
meets the surgical indications for cardiac diseases related to the Chinese Expert Consensus on the 
Treatment of Cardioembolic Stroke (2022) (including left atrial appendicular occlusion, left atrial 
appendicular ligation, and atrial fibrillation radiofrequency ablation recommended for high-risk 
stroke patients with atrial fibrillation; Transcatheter PFO occlusion is recommended for cryptogenic 
stroke patients with high-risk PFO; Valve repair or replacement is recommended for patients with 
valvular disease. Left atrial appendage ligation or left atrial appendage clip is recommended for 
patients with atrial fibrillation.); ③ understood and voluntarily signed the informed consent form. 
Exclusion criteria: ① with severe mental disorder and unable to express intention; ② with 
other abnormal signs, laboratory tests and clinical diseases, not suitable to attend investigator; ③ 
and unable to complete long-term follow-up. 
2. Study and design flow chart: 
 
 
 

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3. Sample size determination method required for the study: 
This study through the real world cohort research, to cross professional association as a 
breakthrough point, with standardization, standardization for innovation, establish interdisciplinary 
diagnosis and treatment team, establish "screening-prevention-diagnosis and treatment" standardized 
process, for cardiac stroke high-risk patients to choose standard diagnosis and treatment basis, 
optimize the current diagnosis and treatment process and professional technology. It is expected that 
1,200 patients at high risk of cardioembolic stroke will be included in a time period of 1-1.5 years. It 
should be pointed out that if compared with conventional diagnosis and treatment methods, patients 
matched with multiple factors in the same period are selected as the control group. 

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Clinical Research Project Program                                                        Version No.: V1.0 Version Date: December 10,2021 
6. Safety evaluation (including the definition and evaluation of adverse events and 
serious adverse events) 
 
1. Definition of adverse events: adverse medical events that occur in the course of this standard 
treatment of the subject, whether they are drug-related or not. 
2. Abnormal laboratory and instrument examination results. 
3. Serious adverse events: Major adverse events may be drug-related, including but not limited to 
the following: 
(a) Abnormal laboratory indicators (including liver and kidney function, etc.); 
(b) Allergic reaction to antiplatelet drugs / anticoagulants; 
(c) Stroke / transient ischemic attack or neurological deficit; 
(d) Spontaneous bleeding: such as petechia, ecchymosis, digestive system and urinary system 
bleeding; 
(e) Central nervous system damage. 
4. Assessment of the severity level 
Light: do not affect the daily activities; 
In: affect daily activities; 
 
Heavy: loss of daily activity ability. 
 
 
 

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Clinical research project proposal plan 
7. Data collection and management 
 
Version Number: V1.0 Version Date: December 10,202
 
1. Survey content (CRF table) 
variable: 
a) Basic information of patients: name, gender, age, education level, combined diseases, 
past medical history, etc.; 
b) Admission status: chief complaints of symptoms, general condition, vital signs, 
CHA2DS2-VASc score, nutrition questionnaire and epidemiological data etc.; 
c) Pre-treatment laboratory and instrument examination: biochemical indicators, nutrient 
index (one carbon unit substance), electrocardiogram, dynamic electrocardiogram, 
cardiac color doppler ultrasound, foaming test, cardiac CTA, craniocerebral CT and 
MRI, internal and external intracranial artery evaluation, etc.; 
d) Treatment medication; surgical conditions 
e) The occurrence of adverse events during the hospitalization period; 
f) 
Situation at follow-up: chief complaint of symptoms, general condition, vital signs, 
Quality of Life , HAS-BLED score, etc.; 
g) Laboratory and instrumental examination at follow-up: biochemical indicators, 
electrocardiogram, cardiac color ultrasound, cardiac CTA, craniocerebral CT and MRI, 
internal and external intracranial artery evaluation, etc.; 
h) occurrence of adverse events during follow-up. 
2. Data management and statistical analysis 
For All the subjects who have signed the informed consent form and are qualified to be 
selected, all the items in the electronic medical record report form should be carefully recorded 
in detail, without no empty or missing items. 
The investigator records the data into the electronic medical record report according to the 
original records and inpatient records, and the investigator ensures that the data is true and 
accurate. 
Data that are significantly high or outside the clinical acceptance range should be verified 
with necessary explanation by the investigator. 
The researcher will modify the data due to filling reasons, and the dialog box will pop up in 
the electronic medical record report form, and the researcher should indicate the reason for the 
modification. Any modification by the researcher leaves a mark to ensure the authenticity of the 
data. 
After the investigator fills in the data and the supervisor monitors, the investigator solves all 
the data questions and ensures that the accuracy of the data is determined, the data administrator 
locks the database. The data management personnel, principal researchers, statistical analysts, 
implementers and monitoring management personnel will jointly review the data, and complete 
the final definition and judgment of the analysis population, and then the data manager will 
finally lock the database. 
The locked database or files should generally not be changed again. 
 

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Clinical Research Project Program                                                         Version No.: V1.0 Version Date: December 10,2021 
8. Quality Management Plan (please introduce relevant measures to ensure project 
quality and progress) 
 
Surveillance of the observational cohort studies 
During the study, the inspectors will regularly visit the research center to ensure that all the 
content of the research protocol is strictly followed, and the original data is checked to ensure 
that the data filling content is true, complete and correct. 
1. Method of determination 
(1) Brain CT and MRI;  
(2) Electrocardiogram or dynamic electrocardiogram: 12-lead routine electrocardiogram; 
24-hour dynamic electrocardiogram monitoring  
(3) Blood routine test, urine routine test, liver and kidney function test, blood biochemical 
indexes: automatic biochemical analyzer;  
(4) Nutrients (one carbon unit substance) : mass spectrometry or biochemistry  
(5) Cardiac ultrasonography;  
(6) Cardiac CTA  
(7) Surgical records  
(8) Combined medication  
(9) Relevant scales should be applied with international common scale or Chinese version  
(10) Record of adverse events. 
2. Fill in the electronic case report form 
Electronic case report form (CRF) was used in this trial. For All subjects who have signed 
the informed consent form and are qualified to be selected, all items in the electronic medical 
record report form should be recorded carefully and detail, with no empty or missing items. All 
data in the EHR report form should be checked with the original subject medical record data to 
ensure correct accuracy. The investigators ensure that the data are true and accurate. 
3. Preservation of the original materials 
The original data of this trial includes signed informed consent, release records of test 
products, relevant laboratory test reports, case records and other relevant records, and should be 
kept in the national drug clinical trial institution of the hospital where the research center is 
located . Medical institutions shall keep the clinical trial data until five years after the 
termination of the trial. The implementer shall keep the data of the clinical trial until ten years 
after the last produced product is put into use. 
 

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Clinical Research Project Program                                                          Version No.: V1.0 Version Date: December 10,2021 
9. Pre-assessment and risk control plan of the project risk and benefits (please 
describe the possible risks and benefits of the researchers, the subjects and their 
medical institutions when conducting the project. If there are risks, please introduce 
the risk control measures and feasibility.） 
 
1. Benefit / risk assessment 
(1) Benefit: through the real world cohort research, to cross-professional collaboration as a 
breakthrough point, to diagnosis and treatment standardization, standardization for 
innovation, establish interdisciplinary treatment team, establish "high-risk patients with 
cardioembolic stroke (acute stroke) -MDT-standardized diagnosis and treatment-
rehabilitation treatment" standardized process, optimize the current diagnosis and treatment 
process and professional technology. 
(2) Possible risks: 
1) Abnormal laboratory indicators (including liver and kidney function, etc.); 
2) Allergic reaction to antiplatelet drugs / anticoagulants; 
3) Stroke / transient ischemic attack or neurological deficit; 
4) Spontaneous bleeding: such as petechia, ecchymosis, digestive system and urinary 
system bleeding; 
5) Central nervous system damage. 
2. Ethics and ethics 
(1) Ethics Committee (should describe how the plan was approved by the Research Ethics 
Committee / Institutional Review Board) 
1) Conclusion: Cardiac stroke accounts for 14% ~ 30% of ischemic stroke, and the 
condition is more serious, with high mortality rate, disability rate and recurrence 
rate. Cardiac stroke mostly has clear underlying diseases or risk factors of the 
cardiovascular system, including valvular heart disease, atrial fibrillation, PFO and 
so on. There are disciplinary barriers to prevention and treatment of cardiac stroke, 
standardized diagnosis and treatment process, clinical application of related surgical 
instruments is still in the initial stage, such as precision treatment, and need to 
optimize the current treatment process and professional technology, prevention and 
treatment of cardiac stroke, this project explores multidisciplinary collaborative 
treatment mode of cardiac stroke, and develops standardized diagnosis and 
treatment process and related professional technology. 
2) General situation of the undertaking unit (personnel, assets, business and 
management status): 
The second Affiliated Hospital of Nanchang University is the tertiary hospital, 
neurosurgery is the first neurosurgery specialty in Jiangxi Province, has become a key 
specialty, neurosurgery medical, teaching and research center of Nanchang University, 
with long-term follow-up database and specimen database, laid a solid foundation for the 
smooth implementation of this work. Professor Xingen Zhu, the applicant of the project, 
was approved as the "Changjiang Scholar distinguished Professor" of the Ministry of 
Education, and is the "only professor" in the medical field of the province. This project 
sets related advantageous units and experts, covering production, learning, research, 
medical, inspection, use and other industries, covering research and development, 
production, testing, application and other links. At present, the project leader has 
established a scientific research team for basic BI research and stem cell intervention, 
whose core members have more than ten years of scientific research attainments in the 
fields of molecular biology, cell biology and clinical research. The personnel involved in 
this project all have a good training background, clinical translational research 

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experience, and laboratory work background, which is helpful Completed the study of 
this project. 
 

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3) Advantages of the participating units: 
The Second Affiliated Hospital of Nanchang University of the "China Five-Star 
Advanced Stroke Center" won the title of "National Five-Star Advanced Stroke Center" of the 
Stroke Prevention and Treatment Engineering Committee of the National Health Commission in 
2020. The second affiliated hospital of Nanchang university has been committed to provide 
efficient, high quality first aid green channel for stroke patients, formally established in 2015 
stroke center, the same year approved "national senior stroke center", in 2018 in the national 
difficult disease (cerebrovascular disease) diagnosis and treatment promotion project (the only) in 
the province, the hospital established the cerebrovascular disease center, in 2018,2019,2020 
consecutive "China five-star senior stroke center" title. The second Affiliated Hospital has solid 
technical strength and the support of the diagnosis and treatment of difficult cerebrovascular 
diseases. The second affiliated hospital of Nanchang university will continue to play a "China 
five-star senior stroke center" regional leading role, with the help of the couplet of medical, 
network hospital, remote consultation, nervous system difficult severe alliance platform, 
strengthen the training supervision, further quality medical resources sinking, at the same time to 
strengthen the construction of stroke prevention alliance, cultivate more stroke professional 
doctors, make greater contribution to stroke prevention and control, benefit more people; 
In 2016, the Second Affiliated Hospital of Nanchang University took the lead in 
opening the "medical imaging cloud service platform", realizing the image "cloud storage" and 
remote film reading consultation. In 2019, with the help of cloud platform and professional 
operation team, the hospital established medical consortium cooperation with 111 secondary and 
above hospitals in the province. The telemedicine business effectively radiated to the whole 
province, realizing more than 100 cases of difficult diseases in a single month, and solved the 
problem of remote people running to see a doctor with practical measures. The remote 
consultation system breaks the restrictions of time, space and region, and enables high-quality 
medical resources to sink, so that residents in remote areas can enjoy the diagnosis and treatment 
of provincial medical experts without traveling hard and win valuable medical treatment time. At 
the same time, grassroots hospitals can also invite experts from provincial hospitals to conduct 
remote consultation, so as to help grassroots doctors to diagnose difficult diseases and receive 
support from medical technology. Each consultation process is an opportunity to receive 
telemedicine education and training. In the future, the construction of a comprehensive and 
interconnected remote platform will bring more convenient and accurate medical services to the 
diagnosis and treatment of difficult diseases of cardioembolic stroke. 
(2) Patient information and informed consent: 
This cohort study was conducted in accordance with the requirements of the current 
Declaration of Helsinki, medical device clinical trial regulations, GCP, and relevant national 
regulations. 
Before the start of the study, the investigator should submit the study protocol, informed 
consent form and other relevant documents to the medical ethics committee of the hospital 
responsible for the clinical trial. Clinical trials can not be started until after obtaining ethics 
committee approval. Any modification to the study protocol must be approved by the ethics 

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committee before being implemented. Serious adverse events during the clinical trial should be 
promptly presented in writing to the ethics committee. 
Prior to inclusion in this study, the investigator must provide the subject and his relatives 
with the details of the clinical trial, including the purpose of the trial, expected efficacy, possible 
adverse events, and countermeasures. They will be selected after the subjects fully understood 
the trial, accepted the informed process, and signed the informed consent. 
The Informed consent was jointly signed by the study physician and the subject himself or his 
legal representative in duplicate, with one copy kept for each party.