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

China National Center for Cardiovascular Diseases0 个研究点目标入组 800 人开始时间: 2026年1月1日最近更新: 2025年12月31日

适应症

试验速览

阶段: 不适用
状态: 尚未招募
发起方
入组人数: 800
主要终点: Area Under the Receiver Operating Characteristic Curve (AUC) for Risk Model Performance

研究概览研究设计入排标准结局指标研究者记录与标识符相似试验

研究概览

简要总结

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.

研究设计

研究类型: Observational
观察模型: Cohort
时间视角: Prospective

入排标准

年龄范围: 70 Years 至 —（Older Adult）
性别: All
接受健康志愿者: 否

入选标准

•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.

排除标准

•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.

结局指标

主要结局

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

时间窗: At completion of 2-year follow-up

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

次要结局

Positive Predictive Value (PPV)(At completion of 2-year follow-up)
Hosmer-Lemeshow Goodness-of-Fit Statistic(At completion of 2-year follow-up)
Calibration Slope(At completion of 2-year follow-up)
Sensitivity of the Prediction Model(At completion of 2-year follow-up)
Specificity of the Prediction Model(At completion of 2-year follow-up)
Negative Predictive Value (NPV)(At completion of 2-year follow-up)
Decision Curve Analysis (DCA)(At completion of 2-year follow-up)

研究者

发起方

China National Center for Cardiovascular Diseases

申办方类型

Other Gov

责任方

Sponsor

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