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

NCT ID: NCT07311954

Last Updated: 2025-12-31

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

NOT_YET_RECRUITING

Total Enrollment

800 participants

Study Classification

OBSERVATIONAL

Study Start Date

2026-01-01

Study Completion Date

2029-01-01

Brief Summary

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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.

Detailed Description

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Conditions

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Coronary Artery Disease Elderly (Aged >70)

Keywords

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coronary computed tomography angiography frailty biomarker

Study Design

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Observational Model Type

COHORT

Study Time Perspective

PROSPECTIVE

Study Groups

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Model Development and Validation Cohort

No Intervention: Observational Cohort

Intervention Type OTHER

No intervention will be conducted.

Interventions

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No Intervention: Observational Cohort

No intervention will be conducted.

Intervention Type OTHER

Eligibility Criteria

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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.
Minimum Eligible Age

70 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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China National Center for Cardiovascular Diseases

OTHER_GOV

Sponsor Role lead

Central China Fuwai Hospital of Zhengzhou University

OTHER

Sponsor Role collaborator

Chinese Academy of Medical Sciences, Fuwai Hospital

OTHER

Sponsor Role collaborator

Responsible Party

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Responsibility Role SPONSOR

Central Contacts

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Zhe Zheng, MD, PhD

Role: CONTACT

Phone: +86 88396051

Email: [email protected]

Other Identifiers

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2025-2970

Identifier Type: -

Identifier Source: org_study_id