Development and Validation of a cCTA and Biomarker Based Risk Model for Coronary Revascularization in Elderly Patients With Coronary Artery Disease

National Center for Cardiovascular Diseases

Status: Not yet enrolling

Conditions: Elderly (Aged >70); Coronary Artery Disease

Treatments: Other: No Intervention: Observational Cohort

Study type: Observational

Funder types: Other

Identifiers

NCT07311954

2025-2970

Details and patient eligibility

About

This study is a prospective multi-center observational cohort involving elderly patients (≥70 years old) with multi-vessel coronary disease identified by coronary computed tomography angiography (cCTA) and scheduled for invasive coronary angiography. Data collection about cCTA, frailty and biomarkers and two-year follow-up will be conducted to develop and validate a risk model of coronary revascularization.

Enrollment: 800 estimated patients

Sex: All

Ages: 70+ years old

Volunteers: No Healthy Volunteers

Inclusion criteria

1. Age ≥ 70 years.
2. Multivessel coronary artery disease identified on coronary computed tomography angiography (CCTA), defined as ≥50% stenosis in at least two of the three major epicardial coronary arteries.
3. Scheduled to undergo invasive coronary angiography as part of standard clinical care.
4. Able to provide informed consent, or consent provided by a legally authorized representative.

Exclusion criteria

1. Previous coronary revascularization, including percutaneous coronary intervention (PCI) or coronary artery bypass grafting (CABG).
2. Acute myocardial infarction at admission, according to electrocardiographic findings and elevated cardiac biomarkers consistent with acute MI.
3. Poor-quality CCTA images that prevent accurate assessment of coronary plaque characteristics or stenosis severity.
4. Refusal or inability to participate in the study or to provide informed consent.

Trial design

800 participants in 1 patient group

Model Development and Validation Cohort

Treatment:

Other: No Intervention: Observational Cohort