About this trial
The present case-control study is designed to investigate the disease characteristics of rapidly progressive coronary artery disease (R-CAD) by comparing the demographics, clinical features, lab results, imaging findings, and prior treatment between patients in the case group (approximately 34 patients with R-CAD) and those in the control group (approximately 18 patients with non-rapidly progressive coronary artery disease \[NR-CAD\]).
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 CABG).
Receiving standard treatment for secondary prevention of AS-CAD after the latest coronary revascularization.
Disqualifiers
Receiving immunosuppressive therapy within 6 months.
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 malignancy (diagnosed within 12 months or with ongoing requirement for treatment).
Trial population
Patients who fulfill the inclusion/exclusion criteria for R-CAD defined by the protocol of the present case-control study will be enrolled in the case group of the present case-control study. Patients who fulfill the inclusion/exclusion criteria for NR-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
Retrospective
Treatments tested in this trial
Protocol-defined Examinations and Evaluations
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, 6-minute walk test, vascular ultrasound, coronary angiography, optical coherence tomography (OCT), fibroblast activation protein inhibitor positron emission tomography/computed tomography (FAPI-PET/CT), photon-counting detector coronary computed tomography angiography (PCD-CCTA), tests for exploratory biomarkers.
Treatment groups
Trial outcomes
Primary outcomes
Elevated ESR or hs-CRP
Percentage of patients with elevated ESR (\> 15 mm/h for male or \> 20 mm/h for female) or hs-CRP (≥ 2 mg/L).
Secondary outcomes
Positive autoantibodies
Percentage of patients with positive autoantibodies (anti-nuclear antibody \[ANA\], anti-neutrophil cytoplasmic antibody \[ANCA\], anti-endothelial cell antibody \[AECA\], lupus anticoagulant \[LA\], antiphospholipid antibody (APL) (anti-cardiolipin antibody \[ACL\], anti-beta2-glycoprotein 1 antibody \[abeta2GP1\]), anti-phosphatidylserine antibody \[APSA\], rheumatoid factor \[RF\], anti-cyclic citrullinated peptide antibody \[anti-CCP\], et al.).
Established diagnosis of chronic inflammatory diseases
Percentage of patients with established diagnosis of chronic inflammatory diseases (chronic infectious disease, autoimmune disease, other chronic inflammatory diseases, et al.).
Elevated ESR or hs-CRP, or positive autoantibodies
Percentage of patients with elevated ESR or hs-CRP, or positive autoantibodies.
Elevated ESR or hs-CRP, or positive autoantibodies, or established diagnosis of chronic inflammatory diseases
Percentage of patients with elevated ESR or hs-CRP, or positive autoantibodies, or established diagnosis of chronic inflammatory diseases.
Other outcomes
Maximum standardized uptake value (SUVmax)
SUVmax based on fibroblast activation protein inhibitor positron emission tomography/computed tomography (FAPI-PET/CT).
Maximum target background ratio (TBRmax)
TBRmax based on fibroblast activation protein inhibitor positron emission tomography/computed tomography (FAPI-PET/CT).
Fat attenuation index (FAI)
FAI based on photon-counting detector coronary computed tomography angiography (PCD-CCTA).
Locations
Sponsors and contacts
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