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

NCT07311954 | Not Yet Recruiting

• 1 other identifier: 2025-2970
• Study Type: observational
• Target: 800
• Locations: 0 countries
• Sites: N/A

Brief Summary

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.

Conditions

Coronary Artery Disease; Elderly (Aged >70)

Keywords

coronary computed tomography angiography; frailty; biomarker

Outcome Measures

Primary Outcomes (1)

• Area Under the Receiver Operating Characteristic Curve (AUC) for Risk Model Performance

  AUC evaluates the model's discrimination performance in predicting MACCEs at 24 months.

  At completion of 2-year follow-up

Secondary Outcomes (7)

• Sensitivity of the Prediction Model

  At completion of 2-year follow-up

• Specificity of the Prediction Model

  At completion of 2-year follow-up

• Positive Predictive Value (PPV)

  At completion of 2-year follow-up

• Negative Predictive Value (NPV)

  At completion of 2-year follow-up

• Hosmer-Lemeshow Goodness-of-Fit Statistic

  At completion of 2-year follow-up

Study Arms (1)

Model Development and Validation Cohort

Other: No Intervention: Observational Cohort

Interventions

No Intervention: Observational Cohort OTHER

No intervention will be conducted.

Model Development and Validation Cohort

Eligibility Criteria

• Age: 70 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Older Adult (65+)
• Sampling Method: Probability Sample

Study Population

Elderly patients aged 70 years and older with multivessel coronary artery disease identified by coronary CT angiography and scheduled to undergo invasive coronary angiography at participating centers.

You may qualify if:

• Age ≥ 70 years.
• 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.
• Scheduled to undergo invasive coronary angiography as part of standard clinical care.
• Able to provide informed consent, or consent provided by a legally authorized representative.

You may not qualify if:

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

Sponsors & Collaborators

• China National Center for Cardiovascular Diseases: lead
• Central China Fuwai Hospital of Zhengzhou University: collaborator
• Chinese Academy of Medical Sciences, Fuwai Hospital: collaborator

MeSH Terms

Conditions

Coronary Artery Disease; Frailty

Condition Hierarchy (Ancestors)

Coronary Disease; Myocardial Ischemia; Heart Diseases; Cardiovascular Diseases; Arteriosclerosis; Arterial Occlusive Diseases; Vascular Diseases; Pathologic Processes; Pathological Conditions, Signs and Symptoms

Central Study Contacts

Zhe Zheng, MD, PhD

CONTACT

+86 88396051; zhengzhe@fuwai.com

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: PROSPECTIVE
• Sponsor Type: OTHER GOV
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: December 17, 2025
• First Posted: December 31, 2025
• Study Start: January 1, 2026
• Primary Completion (Estimated): January 1, 2029
• Study Completion (Estimated): January 1, 2029
• Last Updated: December 31, 2025

Record last verified: 2025-12

Data Sharing

• IPD Sharing: Will not share