Disease Characteristics of IR-CAD: a Case-control Study

Recruiting

• Conditions: Coronary Artery Disease; Coronary Artery Stenosis; Coronary Artery Disease Progression; Inflammation; Inflammatory Disease; Inflammation Vascular; Coronary Artery Restenosis
• Interventions: Diagnostic Test: Protocol-defined Examinations

• Registration Number: NCT06007248
• Lead Sponsor: Peking Union Medical College Hospital

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.

Study Timeline

• Study First Submitted: 2023-07-07
• Study First Submitted QC: 2023-08-17
• Study First Posted: 2023-08-23
• Study Start: 2023-11-02
• Status Verified: 2024-11
• Last Update Submitted: 2024-11-13
• Last Update Posted: 2024-11-15
• Primary Completion: 2025-09
• Study Completion: 2025-09

Recruitment & Eligibility

• Status: RECRUITING
• Sex: All
• Target Recruitment: 30

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).

Study & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Arm && Interventions

Group	Intervention	Description
Case Group	Protocol-defined Examinations	IR-CAD patients (from the IR-CAD cohort study)
Control Group	Protocol-defined Examinations	AS-CAD patients

Primary Outcome Measures

Name	Time	Method
Elevated erythrocyte sedimentation rate (ESR)	From the last coronary revascularization up to 2 weeks of enrollment, but before the initiation of comprehensive treatment for patients with IR-CAD.	Percentage of patients with elevated ESR (\> 15 mm for male or \> 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.

Secondary Outcome Measures

Name	Time	Method
Immunosuppressive agents	On the day of enrollment.	Percentage of patients on immunosuppressive agents.
Antithrombotic agents	On the day of enrollment.	Percentage of patients on antithrombotic agents.
Body weight	On the day of enrollment.	Measurement of body weight.
Smoking	On the day of enrollment.	Percentage of patients with prior history of smoking.
Old myocardial infarction (OMI)	On the day of enrollment.	Percentage of patients with prior history of OMI.
Coronary artery bypass graft (CABG)	On the day of enrollment.	Percentage of patients with prior history of CABG.
Blood pressure	On the day of enrollment.	Measurement of blood pressure.
Heart rate	On the day of enrollment.	Measurement of heart rate.
Female sex	On the day of enrollment.	Percentage of patients with female sex.
Acute coronary syndrome (ACS)	On the day of enrollment.	Percentage of patients admitted due to ACS for the index hospitalization.
White blood cell	From the index hospital admission up to 2 weeks of enrollment, but before the initiation of comprehensive treatment for patients with IR-CAD.	Test result of white blood cell count.
Total bilirubin (T-Bil)	From the index hospital admission up to 2 weeks of enrollment, but before the initiation of comprehensive treatment for patients with IR-CAD.	Test result of T-Bil.
Thyroxine (T4)	From the index hospital admission up to 2 weeks of enrollment, but before the initiation of comprehensive treatment for patients with IR-CAD.	Test result of T4.
Free triiodothyronine (FT3)	From the index hospital admission up to 2 weeks of enrollment, but before the initiation of comprehensive treatment for patients with IR-CAD.	Test result of FT3.
Total cholesterol (TC)	From the index hospital admission up to 2 weeks of enrollment, but before the initiation of comprehensive treatment for patients with IR-CAD.	Test result of TC.
Hemoglobin A1c (HbA1c).	From the index hospital admission up to 2 weeks of enrollment, but before the initiation of comprehensive treatment for patients with IR-CAD.	Test result of HbA1c.
Cardiac troponin I (cTnI)	From the index hospital admission up to 2 weeks of enrollment, but before the initiation of comprehensive treatment for patients with IR-CAD.	Test result of cTnI.
Antiphospholipid antibody	From the index hospital admission up to 2 weeks of enrollment, but before the initiation of comprehensive treatment for patients with IR-CAD.	Test result of antiphospholipid antibody.
Protein S	From the index hospital admission up to 2 weeks of enrollment, but before the initiation of comprehensive treatment for patients with IR-CAD.	Test result of Protein S.
Anti-thrombin III	From the index hospital admission up to 2 weeks of enrollment, but before the initiation of comprehensive treatment for patients with IR-CAD.	Test result of anti-thrombin III.
Anti-nuclear antibody (ANA)	From the index hospital admission up to 2 weeks of enrollment, but before the initiation of comprehensive treatment for patients with IR-CAD.	Test result of ANA.
Glucocorticoids	On the day of enrollment.	Percentage of patients on glucocorticoids.
Age	On the day of enrollment.	Age in years.
Yellow race	On the day of enrollment.	Percentage of patients with yellow race.
Hypertension	On the day of enrollment.	Percentage of patients with prior history of hypertension.
Number of prior coronary revascularization	On the day of enrollment.	Number of prior coronary revascularization
Hypoglycemic agents	On the day of enrollment.	Percentage of patients on hypoglycemic agents.
Target vessel related major adverse cardiovascular events (TV-MACE)	From the last coronary revascularization up to the day of enrollment.	Percentage of patients with cardiovascular death, or target vessel related Q wave myocardial infarction, or target vessel related unplanned myocardial ischemia-driven coronary revascularization (PCI or CABG), or target vessel related unplanned myocardial ischemia-driven hospitalization.
Aspartate aminotransferase (AST)	From the index hospital admission up to 2 weeks of enrollment, but before the initiation of comprehensive treatment for patients with IR-CAD.	Test result of AST.
Blood urea nitrogen (BUN)	From the index hospital admission up to 2 weeks of enrollment, but before the initiation of comprehensive treatment for patients with IR-CAD.	Test result of BUN.
High-density lipoprotein cholesterol (HDL-C)	From the index hospital admission up to 2 weeks of enrollment, but before the initiation of comprehensive treatment for patients with IR-CAD.	Test result of HDL-C.
Lipoprotein (a) (Lp[a])	From the index hospital admission up to 2 weeks of enrollment, but before the initiation of comprehensive treatment for patients with IR-CAD.	Test result of Lp(a).
Fasting blood glucose (FBG)	From the index hospital admission up to 2 weeks of enrollment, but before the initiation of comprehensive treatment for patients with IR-CAD.	Test result of FBG.
Creatine kinase-myocardial band (CK-MB)	From the index hospital admission up to 2 weeks of enrollment, but before the initiation of comprehensive treatment for patients with IR-CAD.	Test result of CK-MB.
Creatine kinase (CK)	From the index hospital admission up to 2 weeks of enrollment, but before the initiation of comprehensive treatment for patients with IR-CAD.	Test result of CK.
Dyslipidemia	On the day of enrollment.	Percentage of patients with prior history of dyslipidemia.
Percutaneous coronary intervention (PCI)	On the day of enrollment.	Percentage of patients with prior history of PCI.
Height	On the day of enrollment.	Measurement of height.
Blood pressure-lowering agents	On the day of enrollment.	Percentage of patients on blood pressure-lowering agents.
Lipid-lowering agents	On the day of enrollment.	Percentage of patients on lipid-lowering agents.
Other immunosuppressive therapy	On the day of enrollment.	Percentage of patients on other immunosuppressive therapy.
Major adverse cardiovascular events (MACE)	From the last coronary revascularization up to the day of enrollment.	Percentage of patients with death, or Q wave myocardial infarction, or unplanned myocardial ischemia-driven coronary revascularization (PCI or CABG), or unplanned myocardial ischemia-driven hospitalization.
Red blood cell	From the index hospital admission up to 2 weeks of enrollment, but before the initiation of comprehensive treatment for patients with IR-CAD.	Test result of red blood cell count.
Lactate dehydrogenase (LDH)	From the index hospital admission up to 2 weeks of enrollment, but before the initiation of comprehensive treatment for patients with IR-CAD.	Test result of LDH.
Albumin	From the index hospital admission up to 2 weeks of enrollment, but before the initiation of comprehensive treatment for patients with IR-CAD.	Test result of Albumin
Triiodothyronine (T3)	From the index hospital admission up to 2 weeks of enrollment, but before the initiation of comprehensive treatment for patients with IR-CAD.	Test result of T3.
Chronic coronary syndrome (CCS).	On the day of enrollment.	Percentage of patients admitted due to CCS for the index hospitalization.
Diabetes	On the day of enrollment.	Percentage of patients with prior history of diabetes.
β-blockers	On the day of enrollment.	Percentage of patients on β-blockers.
Body mass index (BMI)	On the day of enrollment.	BMI = Body weight \[kg\] / (Height \[m\])\^2
Alkaline phosphatase (ALP)	From the index hospital admission up to 2 weeks of enrollment, but before the initiation of comprehensive treatment for patients with IR-CAD.	Test result of ALP.
Direct bilirubin (D-Bil)	From the index hospital admission up to 2 weeks of enrollment, but before the initiation of comprehensive treatment for patients with IR-CAD.	Test result of D-Bil.
Low-density lipoprotein cholesterol (LDL-C)	From the index hospital admission up to 2 weeks of enrollment, but before the initiation of comprehensive treatment for patients with IR-CAD.	Test result of LDL-C.
Triglyceride (TG)	From the index hospital admission up to 2 weeks of enrollment, but before the initiation of comprehensive treatment for patients with IR-CAD.	Test result of TG.
Apolipoprotein A (ApoA)	From the index hospital admission up to 2 weeks of enrollment, but before the initiation of comprehensive treatment for patients with IR-CAD.	Test result of ApoA.
N-terminal pro-B-type natriuretic peptide (NT-proBNP).	From the index hospital admission up to 2 weeks of enrollment, but before the initiation of comprehensive treatment for patients with IR-CAD.	Test result of NT-proBNP.
Anti-phosphatidylserine antibody	From the index hospital admission up to 2 weeks of enrollment, but before the initiation of comprehensive treatment for patients with IR-CAD.	Test result of anti-phosphatidylserine antibody.
Protein C	From the index hospital admission up to 2 weeks of enrollment, but before the initiation of comprehensive treatment for patients with IR-CAD.	Test result of Protein C.
Anti-neutrophil cytoplasmic antibody (ANCA)	From the index hospital admission up to 2 weeks of enrollment, but before the initiation of comprehensive treatment for patients with IR-CAD.	Test result of ANCA.
Anti-cyclic citrullinated peptide (Anti-CCP)	From the index hospital admission up to 2 weeks of enrollment, but before the initiation of comprehensive treatment for patients with IR-CAD.	Test result of Anti-CCP.
Interleukin (IL)-6	From the index hospital admission up to 2 weeks of enrollment, but before the initiation of comprehensive treatment for patients with IR-CAD.	Test result of IL-6.
Pathological Q waves	From the index hospital admission up to 2 weeks of enrollment, but before the initiation of comprehensive treatment for patients with IR-CAD.	Percentage of patients with pathological Q wave.
Carotid artery stenosis	From the index hospital admission up to 2 weeks of enrollment, but before the initiation of comprehensive treatment for patients with IR-CAD.	Percentage of patients with ≥ 50% diameter stenosis in either carotid artery on vascular ultrasound.
Lower extremity artery stenosis	From the index hospital admission up to 2 weeks of enrollment, but before the initiation of comprehensive treatment for patients with IR-CAD.	Percentage of patients with ≥ 50% diameter stenosis in either lower extremity artery on vascular ultrasound.
Number of vessel segments with coronary lesions.	From the index hospital admission up to 2 weeks of enrollment, but before the initiation of comprehensive treatment for patients with IR-CAD.	Number of vessel segments with ≥ 50% diameter stenosis on coronary angiogram.
Hemoglobin	From the index hospital admission up to 2 weeks of enrollment, but before the initiation of comprehensive treatment for patients with IR-CAD.	Test result of hemoglobin.
Platelet	From the index hospital admission up to 2 weeks of enrollment, but before the initiation of comprehensive treatment for patients with IR-CAD.	Test result of platelet count
Alanine aminotransferase (ALT)	From the index hospital admission up to 2 weeks of enrollment, but before the initiation of comprehensive treatment for patients with IR-CAD.	Test result of ALT.
Gamma-glutamyl transferase (GGT)	From the index hospital admission up to 2 weeks of enrollment, but before the initiation of comprehensive treatment for patients with IR-CAD.	Test result of GGT.
Creatinine	From the index hospital admission up to 2 weeks of enrollment, but before the initiation of comprehensive treatment for patients with IR-CAD.	Test result of creatinine.
Free thyroxine (FT4)	From the index hospital admission up to 2 weeks of enrollment, but before the initiation of comprehensive treatment for patients with IR-CAD.	Test result of FT4.
Thyroid-stimulating hormone (TSH)	From the index hospital admission up to 2 weeks of enrollment, but before the initiation of comprehensive treatment for patients with IR-CAD.	Test result of TSH.
Lupus anticoagulant	From the index hospital admission up to 2 weeks of enrollment, but before the initiation of comprehensive treatment for patients with IR-CAD.	Test result of lupus anticoagulant.
Anti-prothrombin antibody	From the index hospital admission up to 2 weeks of enrollment, but before the initiation of comprehensive treatment for patients with IR-CAD.	Test result of anti-prothrombin antibody.
Rheumatoid factor (RF)	From the index hospital admission up to 2 weeks of enrollment, but before the initiation of comprehensive treatment for patients with IR-CAD.	Test result of RF.
High-sensitivity C-reactive protein (hs-CRP)	From the index hospital admission up to 2 weeks of enrollment, but before the initiation of comprehensive treatment for patients with IR-CAD.	Test result of hs-CRP.
Segmental wall motion abnormality	From the index hospital admission up to 2 weeks of enrollment, but before the initiation of comprehensive treatment for patients with IR-CAD.	Percentage of patients with segmental wall motion abnormality.
Birmingham Vasculitis Activity Score (BVAS)	From the index hospital admission up to 2 weeks of enrollment, but before the initiation of comprehensive treatment for patients with IR-CAD.	Result of BVAS (version 3) assessment.
Number of squats in 1 minute	From the index hospital admission up to 2 weeks of enrollment, but before the initiation of comprehensive treatment for patients with IR-CAD.	Result of 1-minute squatting test (1MST).
Upper extremity artery stenosis	From the index hospital admission up to 2 weeks of enrollment, but before the initiation of comprehensive treatment for patients with IR-CAD.	Percentage of patients with ≥ 50% diameter stenosis in either upper extremity artery on vascular ultrasound.
Apolipoprotein B (ApoB)	From the index hospital admission up to 2 weeks of enrollment, but before the initiation of comprehensive treatment for patients with IR-CAD.	Test result of ApoB.
B-type natriuretic peptide (BNP)	From the index hospital admission up to 2 weeks of enrollment, but before the initiation of comprehensive treatment for patients with IR-CAD.	Test result of BNP.
Immunoglobulin	From the index hospital admission up to 2 weeks of enrollment, but before the initiation of comprehensive treatment for patients with IR-CAD.	Test result of immunoglobulin.
Erythrocyte sedimentation rate (ESR)	From the index hospital admission up to 2 weeks of enrollment, but before the initiation of comprehensive treatment for patients with IR-CAD.	Test result of ESR.
Tumor necrosis factor (TNF)-α.	From the index hospital admission up to 2 weeks of enrollment, but before the initiation of comprehensive treatment for patients with IR-CAD.	Test result of TNF-α.
Dynamic ST-T changes	From the index hospital admission up to 2 weeks of enrollment, but before the initiation of comprehensive treatment for patients with IR-CAD.	Percentage of patients with dynamic ST-T changes.
Left ventricular end-systolic diameter (LVESD)	From the index hospital admission up to 2 weeks of enrollment, but before the initiation of comprehensive treatment for patients with IR-CAD.	Measurement of LVESD.
Subclavian artery stenosis	From the index hospital admission up to 2 weeks of enrollment, but before the initiation of comprehensive treatment for patients with IR-CAD.	Percentage of patients with ≥ 50% diameter stenosis in either subclavian artery on vascular ultrasound.
Iliac artery stenosis	From the index hospital admission up to 2 weeks of enrollment, but before the initiation of comprehensive treatment for patients with IR-CAD.	Percentage of patients with ≥ 50% diameter stenosis in either Iliac artery on vascular ultrasound.
Abdominal aorta stenosis	From the index hospital admission up to 2 weeks of enrollment, but before the initiation of comprehensive treatment for patients with IR-CAD.	Percentage of patients with ≥ 50% diameter stenosis in abdominal aorta on vascular ultrasound.
Renal artery stenosis	From the index hospital admission up to 2 weeks of enrollment, but before the initiation of comprehensive treatment for patients with IR-CAD.	Percentage of patients with ≥ 50% diameter stenosis in either renal artery on vascular ultrasound.
Target lesion percent area stenosis (TL-%AS)	From the index hospital admission up to 2 weeks of enrollment, but before the initiation of comprehensive treatment for patients with IR-CAD.	Measurement of percent area stenosis (% AS) of target lesion = { \[ ( proximal RLA + distal RLA ) - (MLA × 2) \] / ( proximal RLA + distal RLA ) } × 100% in the cross-section with the MLA of the target lesion on optical coherence tomography (OCT). RLA = reference lumen area; MLA = minimum lumen area; % AS = percent area stenosis.
Activated protein C resistance (APC-R)	From the index hospital admission up to 2 weeks of enrollment, but before the initiation of comprehensive treatment for patients with IR-CAD.	Test result of APC-R.
Maximum platelet aggregation (MPA)	From the index hospital admission up to 2 weeks of enrollment, but before the initiation of comprehensive treatment for patients with IR-CAD.	Test result of MPA.
Anti-endothelial cell antibody (AECA)	From the index hospital admission up to 2 weeks of enrollment, but before the initiation of comprehensive treatment for patients with IR-CAD.	Test result of AECA.
Complement	From the index hospital admission up to 2 weeks of enrollment, but before the initiation of comprehensive treatment for patients with IR-CAD.	Test result of complement.
Left atrial diameter (LAD)	From the index hospital admission up to 2 weeks of enrollment, but before the initiation of comprehensive treatment for patients with IR-CAD.	Measurement of LAD.
Walking distance in 6 minutes	From the index hospital admission up to 2 weeks of enrollment, but before the initiation of comprehensive treatment for patients with IR-CAD.	Result of 6-minute walk test (6MWT).
Temporal artery stenosis	From the index hospital admission up to 2 weeks of enrollment, but before the initiation of comprehensive treatment for patients with IR-CAD.	Percentage of patients with ≥ 50% diameter stenosis in either temporal artery on vascular ultrasound.
Celiac trunk stenosis	From the index hospital admission up to 2 weeks of enrollment, but before the initiation of comprehensive treatment for patients with IR-CAD.	Percentage of patients with ≥ 50% diameter stenosis in celiac trunk on vascular ultrasound.
Target lesion minimal lumen area (TL-MLA)	From the index hospital admission up to 2 weeks of enrollment, but before the initiation of comprehensive treatment for patients with IR-CAD.	Measurement of the minimum lumen area of the target lesion on optical coherence tomography (OCT).
Left ventricular end-diastolic diameter (LVEDD)	From the index hospital admission up to 2 weeks of enrollment, but before the initiation of comprehensive treatment for patients with IR-CAD.	Measurement of LVEDD.
Left ventricular ejection fraction (LVEF)	From the index hospital admission up to 2 weeks of enrollment, but before the initiation of comprehensive treatment for patients with IR-CAD.	Measurement of LVEF.
Vertebral artery stenosis	From the index hospital admission up to 2 weeks of enrollment, but before the initiation of comprehensive treatment for patients with IR-CAD.	Percentage of patients with ≥ 50% diameter stenosis in either vertebral artery on vascular ultrasound.
Superior mesenteric artery stenosis	From the index hospital admission up to 2 weeks of enrollment, but before the initiation of comprehensive treatment for patients with IR-CAD.	Percentage of patients with ≥ 50% diameter stenosis in superior mesenteric artery on vascular ultrasound.
SYNTAX score	From the index hospital admission up to 2 weeks of enrollment, but before the initiation of comprehensive treatment for patients with IR-CAD.	Result of SYNTAX score assessment based on coronary angiogram.

Trial Locations

Locations (1)

Peking Union Medical College Hospital; 🇨🇳 Beijing, Beijing, China