Clinical trial NCT06007248: Disease Characteristics of IR-CAD: a Case-control Study
Official title: Disease Characteristics of Inflammation-associated Rapidly-progressive Coronary Artery Disease (IR-CAD): a Case-control Study
Study type: OBSERVATIONAL
Overall status: RECRUITING
Conditions: Coronary Artery Disease
Coronary Artery Stenosis
Coronary Artery Restenosis
Coronary Artery Disease Progression
Inflammation
Inflammatory Disease
Inflammation Vascular
Keywords: Coronary Artery Disease
Coronary Revascularization
Progression, Disease
Inflammation
Characteristics Disease
Lead sponsor: Peking Union Medical College Hospital
Sponsor class: OTHER
First posted: 2023-08-23
Enrollment: 30
Sex: ALL
Minimum age (years): 45
Maximum age (years): 64
Standard ages: ADULT
Accepts healthy volunteers: no
Observational model: CASE_CONTROL
Time perspective: PROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: The first 20 patients who were enrolled in the IR-CAD cohort study, which included patients who met the inclusion/exclusion criteria for IR-CAD and received comprehensive treatment, will be enrolled in the case group of the present IR-CAD case-control study.

Patients who fulfill the inclusion/exclusion criteria for AS-CAD defined by the protocol of the present case-control study will be enrolled in the control group of the present case-control study.

Brief summary: The present case-control study is designed to investigate the disease characteristics of IR-CAD by comparing the demographics, clinical features, lab results, imaging findings, and prior treatment between 20 patients with IR-CAD and 10 patients with AS-CAD.

Detailed description: A special type of coronary artery disease (CAD) has been identified in the investigators' clinical practice, which has completely different clinical features from those of typical atherosclerotic coronary artery disease (AS-CAD). The patients often have sterile inflammatory diseases and/or clinical evidence of inflammation, whose CAD progresses rapidly, recurs frequently, and responds poorly to intensified secondary prevention of AS-CAD, especially after percutaneous coronary intervention (PCI). The investigators name this special type of CAD with inflammation-associated rapidly-progressive coronary artery disease (IR-CAD). Currently, the overall disease characteristics of IR-CAD remain unknown.

The present case-control study is designed to investigate the disease characteristics of IR-CAD by comparing the demographics, clinical features, lab results, imaging findings, and prior treatment between 20 patients with IR-CAD and 10 patients with AS-CAD.

The first 20 patients who were enrolled in the IR-CAD cohort study, which included patients who met the inclusion/exclusion criteria for IR-CAD and received comprehensive treatment, will be enrolled in the case group of the present IR-CAD case-control study. Patients were diagnosed as IR-CAD if they have 1) evidence of rapidly progressive (occurred within 6 months or occurred on immunosuppressive therapy within 12 months of the last coronary revascularization) myocardial ischemia (typical symptoms and non-invasive evidence) despite standard treatment for secondary prevention of AS-CAD; 2) angiographic evidence of new coronary lesions (de novo stenosis or restenosis) considered to be relevant to myocardial ischemia; 3) evidence of inflammation (positive inflammation markers or established diagnosis of inflammatory diseases or use of immunosuppressive therapy). The comprehensive treatment for IR-CAD included: 1) intensified secondary prevention of AS-CAD; 2) immunosuppressive therapy; 3) coronary revascularization; 4) supportive therapies.

Patients who fulfill the inclusion/exclusion criteria for AS-CAD defined by the protocol of the present case-control study will be enrolled in the control group of the present case-control study. Patients will be diagnoses as AS-CAD if they 1) are ≥ 45 but \< 65 years of age; 2) are receiving standard treatment for secondary prevention of AS-CAD after the last PCI which was performed 12±6 months ago; 3) do not have evidence of rapidly progressive (occurred within 6 months or occurred on immunosuppressive therapy within 12 months of the last PCI) myocardial ischemia (typical symptoms and non-invasive evidence); 4) do not have angiographic evidence of new coronary lesions (de novo stenosis or restenosis) considered to be relevant to myocardial ischemia.

Patients in the IR-CAD cohort study underwent examinations after they met the inclusion/exclusion criteria for IR-CAD based on a protocol specifically designed for the clinical management of IR-CAD patients. The results of the above examinations will be used as the examination results of the case group of the present IR-CAD case-control study. While patients in the control group of the present case-control study will undergo similar examinations after enrollment according to the protocol of the present case-control study.

The information regarding the baseline characteristics and the examination results, including demographics, clinical features, lab results, imaging findings, and prior treatment, will be collected and compared between the case group and the control group.

The primary endpoint is the rate of elevated erythrocyte sedimentation rate (ESR).

Eligible patients will be enrolled in the case group and the control group with a 2:1 ratio. The primary endpoint of the present case-control study is elevated erythrocyte sedimentation rate (ESR), which is defined as ESR \> 15 mm for male, or ESR \> 20 mm for female. In case of normal ESR, prior use of immunosuppressive therapy or prior diagnosis of autoimmune diseases before enrollment is regarded as the equivalent to elevated ESR. Based on currently available data from the IR-CAD cohort study, the rate of elevated ESR in the case group (IR-CAD patients) is 88.9% (8/9). The investigators hypothesize that the rate of elevated ESR in the control group (AS-CAD patients) is 20%. In consequence, 20 patients in the case group and 10 patients in the control group would be required to test the difference of the rate of the primary endpoint between the two groups at a significance level of 0.05 (α = 0.05) with a power of 90% (β = 0.10) and a drop-out rate of 20%.

Continuous variables will be presented as mean ± standard deviation (SD) or median (interquartile range \[IQR\]) and compared with two-sample t-test or Wilcoxon rank sum test, as appropriate. Categorical data will be demonstrated as n (%) and compared using Chi-square test or Fisher's exact test, as appropriate.

Eligibility criteria: Inclusion Criteria:

Case group (IR-CAD patients):

1. 18 years of age or older, male or female.
2. Negative results of urine or blood pregnancy test for females with childbearing potential (not post-menopausal or surgically sterile).
3. Prior history of coronary revascularization (PCI or coronary artery bypass graft \[CABG\]).
4. Receiving standard treatment for secondary prevention of AS-CAD after the last coronary revascularization.
5. Hospitalization due to rapidly-progressive myocardial ischemia:

   * Typical symptoms of angina (Canadian Cardiovascular Society \[CCS\] III-IV) and non-invasive evidence of myocardial ischemia; and
   * Occurred within 6 months or occurred on immunosuppressive therapy within 12 months of the last coronary revascularization.
6. Angiographic evidence of new coronary lesions (de novo stenosis or restenosis) considered to be relevant to myocardial ischemia.
7. Evidence of inflammation:

   * At least one of the indexes indicating active inflammation has ever been elevated (ESR, high-sensitivity C-reactive protein \[hs-CRP\], interleukin \[IL\]-6, tumor necrosis factor \[TNF\]-α, ferritin, et al); or
   * Established diagnosis of systemic autoimmune disease or systemic vasculitis; or
   * Receiving immunosuppressive therapy.

Control group (AS-CAD patients):

1. ≥ 45 and \< 65 years of age (based on the age distribution of the patients currently enrolled in the IR-CAD cohort study), male or female.
2. Negative results of urine or blood pregnancy test for females with childbearing potential (not post-menopausal or surgically sterile).
3. Currently, 12±6 months after the last PCI.
4. Receiving standard treatment for secondary prevention of AS-CAD after the last PCI.
5. Coronary angiography and/or optical coherence tomography (OCT) performed during the present hospitalization.
6. No evidence of rapidly-progressive myocardial ischemia, which is defined as follows:

   * Typical symptoms of angina (Canadian Cardiovascular Society \[CCS\] III-IV) and non-invasive evidence of myocardial ischemia; and
   * Occurred within 6 months or occurred on immunosuppressive therapy within 12 months of the last PCI.
7. No angiographic evidence of new coronary lesions (de novo stenosis or restenosis) considered to be relevant to myocardial ischemia.

Exclusion Criteria:

Case group (IR-CAD patients):

1. Coronary restenosis due to mechanical factors (stent under-expansion, stent mal-apposition, stent rupture, et al).
2. Other moderate to severe heart diseases (congenital heart disease, valvular heart disease, myocarditis, cardiomyopathy, pericardial diseases, pulmonary hypertension, heart failure, arrhythmia, et al).
3. Active acute or chronic infection (human immunodeficiency virus \[HIV\], tuberculosis, et al).
4. Active malignancy (diagnosed within 12 months or with ongoing requirement for treatment).
5. Vital organ failure.
6. Life expectancy \< 1 year.
7. Contraindications for or intolerance to treatment for secondary prevention of AS-CAD, contrast agents, glucocorticoids, immunosuppressive agents.
8. In pregnancy or breast-feeding, or with intention to be pregnant during the study period.
9. Risk of non-compliance (history of drug addiction or alcohol abuse, et al).
10. Previous enrollment in this study.
11. Participation in another study within 30 days.
12. Involvement in the planning and conduct of this study (applying to investigators, contract research organization staffs, study site staffs, et al).
13. Any condition, which in the opinion of the investigators, would make it unsuitable for the patient to participate in this study.

Control group (AS-CAD patients):

The same as those for the case group (IR-CAD patients).

Primary outcomes:
measure: Elevated erythrocyte sedimentation rate (ESR)
timeFrame: From the last coronary revascularization up to 2 weeks of enrollment, but before the initiation of comprehensive treatment for patients with IR-CAD.
Secondary outcomes:
measure: Age
timeFrame: On the day of enrollment.
measure: Female sex
timeFrame: On the day of enrollment.
measure: Yellow race
timeFrame: On the day of enrollment.
measure: Acute coronary syndrome (ACS)
timeFrame: On the day of enrollment.
measure: Chronic coronary syndrome (CCS).
timeFrame: On the day of enrollment.
measure: Hypertension
timeFrame: On the day of enrollment.
measure: Dyslipidemia
timeFrame: On the day of enrollment.
measure: Diabetes
timeFrame: On the day of enrollment.
measure: Smoking
timeFrame: On the day of enrollment.
measure: Old myocardial infarction (OMI)
timeFrame: On the day of enrollment.
measure: Percutaneous coronary intervention (PCI)
timeFrame: On the day of enrollment.
measure: Coronary artery bypass graft (CABG)
timeFrame: On the day of enrollment.
measure: Number of prior coronary revascularization
timeFrame: On the day of enrollment.
measure: Blood pressure
timeFrame: On the day of enrollment.
measure: Heart rate
timeFrame: On the day of enrollment.
measure: Body weight
timeFrame: On the day of enrollment.
measure: Height
timeFrame: On the day of enrollment.
measure: Body mass index (BMI)
timeFrame: On the day of enrollment.
measure: Antithrombotic agents
timeFrame: On the day of enrollment.
measure: β-blockers
timeFrame: On the day of enrollment.
measure: Blood pressure-lowering agents
timeFrame: On the day of enrollment.
measure: Lipid-lowering agents
timeFrame: On the day of enrollment.
measure: Hypoglycemic agents
timeFrame: On the day of enrollment.
measure: Glucocorticoids
timeFrame: On the day of enrollment.
measure: Immunosuppressive agents
timeFrame: On the day of enrollment.
measure: Other immunosuppressive therapy
timeFrame: On the day of enrollment.
measure: Major adverse cardiovascular events (MACE)
timeFrame: From the last coronary revascularization up to the day of enrollment.
measure: Target vessel related major adverse cardiovascular events (TV-MACE)
timeFrame: From the last coronary revascularization up to the day of enrollment.
measure: Hemoglobin
timeFrame: From the index hospital admission up to 2 weeks of enrollment, but before the initiation of comprehensive treatment for patients with IR-CAD.
measure: Red blood cell
timeFrame: From the index hospital admission up to 2 weeks of enrollment, but before the initiation of comprehensive treatment for patients with IR-CAD.
measure: White blood cell
timeFrame: From the index hospital admission up to 2 weeks of enrollment, but before the initiation of comprehensive treatment for patients with IR-CAD.
measure: Platelet
timeFrame: From the index hospital admission up to 2 weeks of enrollment, but before the initiation of comprehensive treatment for patients with IR-CAD.
measure: Alanine aminotransferase (ALT)
timeFrame: From the index hospital admission up to 2 weeks of enrollment, but before the initiation of comprehensive treatment for patients with IR-CAD.
measure: Aspartate aminotransferase (AST)
timeFrame: From the index hospital admission up to 2 weeks of enrollment, but before the initiation of comprehensive treatment for patients with IR-CAD.
measure: Gamma-glutamyl transferase (GGT)
timeFrame: From the index hospital admission up to 2 weeks of enrollment, but before the initiation of comprehensive treatment for patients with IR-CAD.
measure: Alkaline phosphatase (ALP)
timeFrame: From the index hospital admission up to 2 weeks of enrollment, but before the initiation of comprehensive treatment for patients with IR-CAD.
measure: Lactate dehydrogenase (LDH)
timeFrame: From the index hospital admission up to 2 weeks of enrollment, but before the initiation of comprehensive treatment for patients with IR-CAD.
measure: Total bilirubin (T-Bil)
timeFrame: From the index hospital admission up to 2 weeks of enrollment, but before the initiation of comprehensive treatment for patients with IR-CAD.
measure: Direct bilirubin (D-Bil)
timeFrame: From the index hospital admission up to 2 weeks of enrollment, but before the initiation of comprehensive treatment for patients with IR-CAD.
measure: Albumin
timeFrame: From the index hospital admission up to 2 weeks of enrollment, but before the initiation of comprehensive treatment for patients with IR-CAD.
measure: Creatinine
timeFrame: From the index hospital admission up to 2 weeks of enrollment, but before the initiation of comprehensive treatment for patients with IR-CAD.
measure: Blood urea nitrogen (BUN)
timeFrame: From the index hospital admission up to 2 weeks of enrollment, but before the initiation of comprehensive treatment for patients with IR-CAD.
measure: Triiodothyronine (T3)
timeFrame: From the index hospital admission up to 2 weeks of enrollment, but before the initiation of comprehensive treatment for patients with IR-CAD.
measure: Thyroxine (T4)
timeFrame: From the index hospital admission up to 2 weeks of enrollment, but before the initiation of comprehensive treatment for patients with IR-CAD.
measure: Free triiodothyronine (FT3)
timeFrame: From the index hospital admission up to 2 weeks of enrollment, but before the initiation of comprehensive treatment for patients with IR-CAD.
measure: Free thyroxine (FT4)
timeFrame: From the index hospital admission up to 2 weeks of enrollment, but before the initiation of comprehensive treatment for patients with IR-CAD.
measure: Thyroid-stimulating hormone (TSH)
timeFrame: From the index hospital admission up to 2 weeks of enrollment, but before the initiation of comprehensive treatment for patients with IR-CAD.
measure: Total cholesterol (TC)
timeFrame: From the index hospital admission up to 2 weeks of enrollment, but before the initiation of comprehensive treatment for patients with IR-CAD.
measure: Low-density lipoprotein cholesterol (LDL-C)
timeFrame: From the index hospital admission up to 2 weeks of enrollment, but before the initiation of comprehensive treatment for patients with IR-CAD.
measure: High-density lipoprotein cholesterol (HDL-C)
timeFrame: From the index hospital admission up to 2 weeks of enrollment, but before the initiation of comprehensive treatment for patients with IR-CAD.
measure: Triglyceride (TG)
timeFrame: From the index hospital admission up to 2 weeks of enrollment, but before the initiation of comprehensive treatment for patients with IR-CAD.
measure: Apolipoprotein A (ApoA)
timeFrame: From the index hospital admission up to 2 weeks of enrollment, but before the initiation of comprehensive treatment for patients with IR-CAD.
measure: Apolipoprotein B (ApoB)
timeFrame: From the index hospital admission up to 2 weeks of enrollment, but before the initiation of comprehensive treatment for patients with IR-CAD.
measure: Lipoprotein (a) (Lp[a])
timeFrame: From the index hospital admission up to 2 weeks of enrollment, but before the initiation of comprehensive treatment for patients with IR-CAD.
measure: Fasting blood glucose (FBG)
timeFrame: From the index hospital admission up to 2 weeks of enrollment, but before the initiation of comprehensive treatment for patients with IR-CAD.
measure: Hemoglobin A1c (HbA1c).
timeFrame: From the index hospital admission up to 2 weeks of enrollment, but before the initiation of comprehensive treatment for patients with IR-CAD.
measure: Cardiac troponin I (cTnI)
timeFrame: From the index hospital admission up to 2 weeks of enrollment, but before the initiation of comprehensive treatment for patients with IR-CAD.
measure: Creatine kinase-myocardial band (CK-MB)
timeFrame: From the index hospital admission up to 2 weeks of enrollment, but before the initiation of comprehensive treatment for patients with IR-CAD.
measure: Creatine kinase (CK)
timeFrame: From the index hospital admission up to 2 weeks of enrollment, but before the initiation of comprehensive treatment for patients with IR-CAD.
measure: B-type natriuretic peptide (BNP)
timeFrame: From the index hospital admission up to 2 weeks of enrollment, but before the initiation of comprehensive treatment for patients with IR-CAD.
measure: N-terminal pro-B-type natriuretic peptide (NT-proBNP).
timeFrame: From the index hospital admission up to 2 weeks of enrollment, but before the initiation of comprehensive treatment for patients with IR-CAD.
measure: Lupus anticoagulant
timeFrame: From the index hospital admission up to 2 weeks of enrollment, but before the initiation of comprehensive treatment for patients with IR-CAD.
measure: Antiphospholipid antibody
timeFrame: From the index hospital admission up to 2 weeks of enrollment, but before the initiation of comprehensive treatment for patients with IR-CAD.
measure: Anti-phosphatidylserine antibody
timeFrame: From the index hospital admission up to 2 weeks of enrollment, but before the initiation of comprehensive treatment for patients with IR-CAD.
measure: Anti-prothrombin antibody
timeFrame: From the index hospital admission up to 2 weeks of enrollment, but before the initiation of comprehensive treatment for patients with IR-CAD.
measure: Protein S
timeFrame: From the index hospital admission up to 2 weeks of enrollment, but before the initiation of comprehensive treatment for patients with IR-CAD.
measure: Protein C
timeFrame: From the index hospital admission up to 2 weeks of enrollment, but before the initiation of comprehensive treatment for patients with IR-CAD.
measure: Activated protein C resistance (APC-R)
timeFrame: From the index hospital admission up to 2 weeks of enrollment, but before the initiation of comprehensive treatment for patients with IR-CAD.
measure: Anti-thrombin III
timeFrame: From the index hospital admission up to 2 weeks of enrollment, but before the initiation of comprehensive treatment for patients with IR-CAD.
measure: Maximum platelet aggregation (MPA)
timeFrame: From the index hospital admission up to 2 weeks of enrollment, but before the initiation of comprehensive treatment for patients with IR-CAD.
measure: Anti-nuclear antibody (ANA)
timeFrame: From the index hospital admission up to 2 weeks of enrollment, but before the initiation of comprehensive treatment for patients with IR-CAD.
measure: Anti-neutrophil cytoplasmic antibody (ANCA)
timeFrame: From the index hospital admission up to 2 weeks of enrollment, but before the initiation of comprehensive treatment for patients with IR-CAD.
measure: Anti-endothelial cell antibody (AECA)
timeFrame: From the index hospital admission up to 2 weeks of enrollment, but before the initiation of comprehensive treatment for patients with IR-CAD.
measure: Rheumatoid factor (RF)
timeFrame: From the index hospital admission up to 2 weeks of enrollment, but before the initiation of comprehensive treatment for patients with IR-CAD.
measure: Anti-cyclic citrullinated peptide (Anti-CCP)
timeFrame: From the index hospital admission up to 2 weeks of enrollment, but before the initiation of comprehensive treatment for patients with IR-CAD.
measure: Immunoglobulin
timeFrame: From the index hospital admission up to 2 weeks of enrollment, but before the initiation of comprehensive treatment for patients with IR-CAD.
measure: Complement
timeFrame: From the index hospital admission up to 2 weeks of enrollment, but before the initiation of comprehensive treatment for patients with IR-CAD.
measure: Erythrocyte sedimentation rate (ESR)
timeFrame: From the index hospital admission up to 2 weeks of enrollment, but before the initiation of comprehensive treatment for patients with IR-CAD.
measure: High-sensitivity C-reactive protein (hs-CRP)
timeFrame: From the index hospital admission up to 2 weeks of enrollment, but before the initiation of comprehensive treatment for patients with IR-CAD.
measure: Interleukin (IL)-6
timeFrame: From the index hospital admission up to 2 weeks of enrollment, but before the initiation of comprehensive treatment for patients with IR-CAD.
measure: Tumor necrosis factor (TNF)-α.
timeFrame: From the index hospital admission up to 2 weeks of enrollment, but before the initiation of comprehensive treatment for patients with IR-CAD.
measure: Pathological Q waves
timeFrame: From the index hospital admission up to 2 weeks of enrollment, but before the initiation of comprehensive treatment for patients with IR-CAD.
measure: Dynamic ST-T changes
timeFrame: From the index hospital admission up to 2 weeks of enrollment, but before the initiation of comprehensive treatment for patients with IR-CAD.
measure: Segmental wall motion abnormality
timeFrame: From the index hospital admission up to 2 weeks of enrollment, but before the initiation of comprehensive treatment for patients with IR-CAD.
measure: Left atrial diameter (LAD)
timeFrame: From the index hospital admission up to 2 weeks of enrollment, but before the initiation of comprehensive treatment for patients with IR-CAD.
measure: Left ventricular end-systolic diameter (LVESD)
timeFrame: From the index hospital admission up to 2 weeks of enrollment, but before the initiation of comprehensive treatment for patients with IR-CAD.
measure: Left ventricular end-diastolic diameter (LVEDD)
timeFrame: From the index hospital admission up to 2 weeks of enrollment, but before the initiation of comprehensive treatment for patients with IR-CAD.
measure: Left ventricular ejection fraction (LVEF)
timeFrame: From the index hospital admission up to 2 weeks of enrollment, but before the initiation of comprehensive treatment for patients with IR-CAD.
measure: Birmingham Vasculitis Activity Score (BVAS)
timeFrame: From the index hospital admission up to 2 weeks of enrollment, but before the initiation of comprehensive treatment for patients with IR-CAD.
measure: Walking distance in 6 minutes
timeFrame: From the index hospital admission up to 2 weeks of enrollment, but before the initiation of comprehensive treatment for patients with IR-CAD.
measure: Number of squats in 1 minute
timeFrame: From the index hospital admission up to 2 weeks of enrollment, but before the initiation of comprehensive treatment for patients with IR-CAD.
measure: Temporal artery stenosis
timeFrame: From the index hospital admission up to 2 weeks of enrollment, but before the initiation of comprehensive treatment for patients with IR-CAD.
measure: Carotid artery stenosis
timeFrame: From the index hospital admission up to 2 weeks of enrollment, but before the initiation of comprehensive treatment for patients with IR-CAD.
measure: Vertebral artery stenosis
timeFrame: From the index hospital admission up to 2 weeks of enrollment, but before the initiation of comprehensive treatment for patients with IR-CAD.
measure: Subclavian artery stenosis
timeFrame: From the index hospital admission up to 2 weeks of enrollment, but before the initiation of comprehensive treatment for patients with IR-CAD.
measure: Iliac artery stenosis
timeFrame: From the index hospital admission up to 2 weeks of enrollment, but before the initiation of comprehensive treatment for patients with IR-CAD.
measure: Upper extremity artery stenosis
timeFrame: From the index hospital admission up to 2 weeks of enrollment, but before the initiation of comprehensive treatment for patients with IR-CAD.
measure: Lower extremity artery stenosis
timeFrame: From the index hospital admission up to 2 weeks of enrollment, but before the initiation of comprehensive treatment for patients with IR-CAD.
measure: Abdominal aorta stenosis
timeFrame: From the index hospital admission up to 2 weeks of enrollment, but before the initiation of comprehensive treatment for patients with IR-CAD.
measure: Celiac trunk stenosis
timeFrame: From the index hospital admission up to 2 weeks of enrollment, but before the initiation of comprehensive treatment for patients with IR-CAD.
measure: Superior mesenteric artery stenosis
timeFrame: From the index hospital admission up to 2 weeks of enrollment, but before the initiation of comprehensive treatment for patients with IR-CAD.
measure: Renal artery stenosis
timeFrame: From the index hospital admission up to 2 weeks of enrollment, but before the initiation of comprehensive treatment for patients with IR-CAD.
measure: SYNTAX score
timeFrame: From the index hospital admission up to 2 weeks of enrollment, but before the initiation of comprehensive treatment for patients with IR-CAD.
measure: Number of vessel segments with coronary lesions.
timeFrame: From the index hospital admission up to 2 weeks of enrollment, but before the initiation of comprehensive treatment for patients with IR-CAD.
measure: Target lesion minimal lumen area (TL-MLA)
timeFrame: From the index hospital admission up to 2 weeks of enrollment, but before the initiation of comprehensive treatment for patients with IR-CAD.
measure: Target lesion percent area stenosis (TL-%AS)
timeFrame: From the index hospital admission up to 2 weeks of enrollment, but before the initiation of comprehensive treatment for patients with IR-CAD.
Other outcomes:
measure: Maximum standardized uptake value (SUVmax)
timeFrame: From the index hospital admission up to 2 weeks of enrollment, but before the initiation of comprehensive treatment for patients with IR-CAD.
measure: RNA sequencing
timeFrame: From the index hospital admission up to 2 weeks of enrollment, but before the initiation of comprehensive treatment for patients with IR-CAD.
measure: Proteomics
timeFrame: From the index hospital admission up to 2 weeks of enrollment, but before the initiation of comprehensive treatment for patients with IR-CAD.
measure: Metabolomics
timeFrame: From the index hospital admission up to 2 weeks of enrollment, but before the initiation of comprehensive treatment for patients with IR-CAD.
Locations:
city: Beijing
country: China
facility: Peking Union Medical College Hospital
state: Beijing
Study officials:
affiliation: Peking Union Medical College Hospital
name: Zhenyu Liu, M.D.
role: PRINCIPAL_INVESTIGATOR
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