About this trial
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.
Eligibility criteria
This trial does not accept healthy volunteersQualifiers
18 years of age or older, male or female.
Negative results of urine or blood pregnancy test for females with childbearing potential (not post-menopausal or surgically sterile).
Prior history of coronary revascularization (PCI or coronary artery bypass graft [CABG]).
Receiving standard treatment for secondary prevention of AS-CAD after the last coronary revascularization.
Disqualifiers
Coronary restenosis due to mechanical factors (stent under-expansion, stent mal-apposition, stent rupture, et al).
Other moderate to severe heart diseases (congenital heart disease, valvular heart disease, myocarditis, cardiomyopathy, pericardial diseases, pulmonary hypertension, heart failure, arrhythmia, et al).
Active acute or chronic infection (human immunodeficiency virus [HIV], tuberculosis, et al).
Active malignancy (diagnosed within 12 months or with ongoing requirement for treatment).
Trial 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.
Trial design
Case-control
Prospective
Treatments tested in this trial
Protocol-defined Examinations
Diagnostic testLab tests (blood and urine and stool routine tests, hepatic and renal and thyroid function tests, tests for metabolic markers, tests for cardiac biomarkers, thrombosis-related tests, rheumatology tests, tests for inflammation markers), electrocardiography, echocardiography, Birmingham Vasculitis Activity Score (BVAS-3), 6-minute walk test, 1-minute squat test, vascular ultrasound, fibroblast activation protein inhibitor (FAPI) positron emission tomography/computed tomography (PET/CT), coronary angiography, optical coherence tomography (OCT), tests for exploratory biomarkers.
Treatment groups
Trial outcomes
Primary outcomes
Elevated erythrocyte sedimentation rate (ESR)
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 outcomes
Age
Age in years.
Female sex
Percentage of patients with female sex.
Yellow race
Percentage of patients with yellow race.
Acute coronary syndrome (ACS)
Percentage of patients admitted due to ACS for the index hospitalization.
Other outcomes
Maximum standardized uptake value (SUVmax)
The mean of SUVmax of each major coronary artery on fibroblast activation protein inhibitor (FAPI) positron emission tomography/computed tomography (PET/CT).
RNA sequencing
Test result of RNA sequencing.
Proteomics
Test result of proteomics.
Metabolomics
Test result of metabolomics.
Sponsors and contacts
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