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NCT Number: NCT07311954

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

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.

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Key information

Conditions

Coronary Artery Disease Arterial Occlusive Diseases Arteriosclerosis Cardiovascular Diseases Coronary Disease Elderly (Aged >70) Frailty Heart Diseases Myocardial Ischemia Pathologic Processes Pathological Conditions, Signs and Symptoms Vascular Diseases

Age range

70 year and older

Sex eligibility

All sexes

Study type

Observational

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

  • 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.

Exclusion criteria

  • 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.

Treatment and study plan

No Intervention: Observational Cohort

Other

No intervention will be conducted.

Primary outcomes

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

    Time frame: At completion of 2-year follow-up

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

Secondary outcomes

  1. Sensitivity of the Prediction Model

    Time frame: At completion of 2-year follow-up

    The proportion of participants who actually experienced MACCEs (Major Adverse Cardiac and Cerebral Events) that were correctly identified by the prediction model as high risk.

  2. Specificity of the Prediction Model

    Time frame: At completion of 2-year follow-up

    The proportion of participants who did not experience MACCEs that were correctly identified by the prediction model as low risk.

  3. Positive Predictive Value (PPV)

    Time frame: At completion of 2-year follow-up

    The probability that subjects identified by the model as high risk truly experienced the adverse events (MACCEs).

  4. Negative Predictive Value (NPV)

    Time frame: At completion of 2-year follow-up

    The probability that subjects identified by the model as low risk truly did not experience the adverse events.

  5. Hosmer-Lemeshow Goodness-of-Fit Statistic

    Time frame: At completion of 2-year follow-up

    A statistical test to assess the calibration of the model. It evaluates whether the observed event rates match the expected event rates in subgroups of the model population. A non-significant p-value indicates good fit.

  6. Calibration Slope

    Time frame: At completion of 2-year follow-up

    Assessment of the agreement between observed outcomes and predicted risks. A slope (beta) of 1 indicates ideal calibration.

  7. Decision Curve Analysis (DCA)

    Time frame: At completion of 2-year follow-up

    Evaluation of clinical net benefit across a range of threshold probabilities.

Study contacts

Contact information is provided by the study sponsor or research team.

Zhe Zheng, MD, PhD

CONTACT

[email protected]

+86 88396051

Sponsors and collaborators

Lead sponsor

China National Center for Cardiovascular Diseases

Other Gov

Collaborators

  • Central China Fuwai Hospital of Zhengzhou University
  • Chinese Academy of Medical Sciences, Fuwai Hospital

Registry information

Important dates

Study start
2026
Primary completion
2029
Study completion
2029
First posted
Dec 31, 2025
Registry last updated
Dec 31, 2025

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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