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NCT07239921

Disease Characteristics of R-CAD

Sponsor: Peking Union Medical College Hospital

View on ClinicalTrials.gov

Summary

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 \[NR-CAD\]).

Official title: Disease Characteristics of Rapidly Progressive Coronary Artery Disease (R-CAD): A Case-control Study

Key Details

Gender

All

Age Range

18 Years - Any

Study Type

OBSERVATIONAL

Enrollment

Start Date

2025-11

Completion Date

2026-10

Last Updated

2025-11-28

Healthy Volunteers

Conditions

Coronary Artery Disease Coronary Artery Disease Progression Coronary Stenosis Coronary Restenosis Coronary Stent Occlusion Myocardial Revascularization Percutaneous Coronary Intervention

Interventions

DIAGNOSTIC_TEST

Protocol-defined Examinations and Evaluations

Lab 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.

Inclusion Criteria: Case Group (R-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 CABG). 4. Receiving standard treatment for secondary prevention of AS-CAD after the latest coronary revascularization. 5. Rapidly progressive myocardial ischemia leading to hospitalization and/or coronary revascularization: 1. Typical symptoms of angina (Canadian Cardiovascular Society \[CCS\] classification III-IV) and non-invasive evidence of myocardial ischemia; and 2. Occurred within 6 months of the latest ischemia-driven hospitalization and/or coronary revascularization. 6. Rapidly progressive coronary lesions leading to myocardial ischemia: 1. Angiographic evidence of new-onset or worsened coronary de novo or restenotic lesions relevant to myocardial ischemia, and 2. Occurred within 6 months of the latest ischemia-driven coronary angiography and/or revascularization. Control Group (NR-CAD patients): 1. 35 to 75 years old\*, male or female. (\* Based on the age distribution characteristics of patients who have been diagnosed as R-CAD.) 2. Negative results of urine or blood pregnancy test for females with childbearing potential (not post-menopausal or surgically sterile). 3. Currently, at 12±6 months after the latest PCI. 4. Receiving standard treatment for secondary prevention of AS-CAD after the latest PCI. 5. Coronary angiography and/or optical coherence tomography (OCT) performed during the index hospitalization. 6. No evidence of rapidly progressive myocardial ischemia and coronary lesions, i.e., not fulfilling items 5) and 6) of the inclusion criteria for R-CAD. Exclusion Criteria: 1. Receiving immunosuppressive therapy within 6 months. 2. Coronary restenosis due to mechanical factors (stent under-expansion, stent mal-apposition, stent rupture, et al). 3. Other moderate to severe heart diseases (congenital heart disease, valvular heart disease, myocarditis, cardiomyopathy, pericardial diseases, pulmonary hypertension, heart failure, arrhythmia, 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. In pregnancy or breast-feeding, or with intention to be pregnant during the study period. 8. Risk of non-compliance (history of drug addiction or alcohol abuse, et al). 9. Previous enrollment in this study. 10. Participation in another study within 30 days. 11. Involvement in the planning and conduct of this study (applying to investigators, contract research organization staffs, study site staffs, et al). 12. Any condition, which in the opinion of the investigators, would make it unsuitable for the patient to participate in this study.