Not Yet RecruitingNot Applicable

Coronary Imaging and Metabolic Indicators-Based Risk Prediction Model for Coronary Artery Disease(CMI-RiskCAD)

China10,960 participantsStarted 2026-01-01

Plain-language summary

The primary design of this study is an ambispective cohort study. We plan to integrate coronary imaging features (including parameters derived from Coronary Computed Tomography Angiography(CCTA) and coronary angiography(CAG)), coronary functional indices (e.g., FFR, QFR), and metabolic biomarkers (e.g., LDL-C, Lp(a), hs-CRP). First, we will develop a multimodal risk prediction model for coronary artery disease using a retrospective cohort; subsequently, we will validate the model in a prospective cohort to assess its performance in discriminating high- versus low-risk individuals and to explore its potential clinical utility for risk stratification and decision-making.

Who can participate

Age range

18 Years

Sex

ALL

See this in plain English?

AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.

Exclusion criteria

. Acute ST-segment elevation myocardial infarction (STEMI) or non-ST-segment elevation myocardial infarction (NSTEMI) occurring within 72 hours; history of coronary artery bypass grafting (CABG); severe valvular heart disease; dilated or hypertrophic cardiomyopathy; congenital heart disease; or heart failure (NYHA functional class III-IV).
. Severe hepatic insufficiency (Child-Pugh class C) or renal failure (estimated glomerular filtration rate \[eGFR\] \< 30 mL/min/1.73m²).
. Pregnancy or lactation.
. Life expectancy of less than 1 year, or any other condition that, in the opinion of the investigator, renders the patient unsuitable for participation in the study.

Questions worth asking your doctor

Bring these to your next appointment. They're a starting point for a shared conversation — not a sign you qualify or a recommendation to enrol.

1Based on my diagnosis and history, is this trial worth exploring for me — or is there a standard treatment we should try first?
2What does this trial's phase tell us about how much is already known about its safety and benefit?
3What would taking part actually involve for me — visits, tests, time, and travel?
4What are the known and possible risks or side effects I should weigh, and how would they be monitored?
5If this trial isn't the right fit, what other options or trials would you suggest I look into?

Generated to help you prepare — always confirm anything about your own eligibility and care with the study team and your doctor.

Questions for the trial coordinator

The trial coordinator is the person who runs the study day to day. These cover the practical side — logistics, costs, and what taking part would actually mean for your life. The study team confirms whether you meet the criteria; these are questions to ask, not a sign you qualify.

1What does taking part actually involve week to week — how many visits, where, and how long does each one take?
2What costs are covered by the study, and what might I have to pay for myself, including travel, parking, or time off work?
3What happens during screening, and what happens if the study team confirms I don't meet the criteria after those tests?
4Who pays for the scans, blood work, and other tests the trial requires — the study, my insurance, or me?
5How will being in the trial affect my regular care, and will my own doctor stay informed and involved?
6Can I leave the trial at any point if I change my mind, and what would happen to my care if I do?

A starting point for the conversation — always confirm anything about your own eligibility, costs, and care with the study team and your doctor.

What they're measuring

The composite endpoint of major adverse cardiovascular events (MACE)

Timeframe: At 12, 24, 36, 48, and 60 months after discharge

Frequency of occurrence of high-risk plaques

Timeframe: baseline, pre-intervention

CT Fractional Flow Reserve gradient

Timeframe: baseline, pre-intervention

Perivascular Fat Attenuation Index

Timeframe: baseline, pre-intervention

PPG derived by follow up CCTA

Timeframe: baseline, pre-intervention

SYNTAX score

Timeframe: immediately after the intervention

Coronary Angiography-derived FFR and Coronary Angiography-derived Index of Microcirculatory Resistance

Timeframe: baseline, pre-intervention

Trial details

NCT IDNCT07353762

SponsorBeijing Anzhen Hospital

Sponsor typeOTHER

Study typeOBSERVATIONAL

Primary completion2035-12-31

Contact for this trial

Chenchen Tu

+8615201648899 tcc2033@mail.ccmu.edu.cn

View on ClinicalTrials.gov More Coronary Artery Disease (CAD) (E.G., Angina, Myocardial Infarction, and Atherosclerotic Heart Disease (ASHD)) trials

Plain-language summary

Who can participate

Age range

18 Years

Sex

ALL

See this in plain English?

AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.

Exclusion criteria

. Acute ST-segment elevation myocardial infarction (STEMI) or non-ST-segment elevation myocardial infarction (NSTEMI) occurring within 72 hours; history of coronary artery bypass grafting (CABG); severe valvular heart disease; dilated or hypertrophic cardiomyopathy; congenital heart disease; or heart failure (NYHA functional class III-IV).
. Severe hepatic insufficiency (Child-Pugh class C) or renal failure (estimated glomerular filtration rate \[eGFR\] \< 30 mL/min/1.73m²).
. Pregnancy or lactation.
. Life expectancy of less than 1 year, or any other condition that, in the opinion of the investigator, renders the patient unsuitable for participation in the study.

What they're measuring

The composite endpoint of major adverse cardiovascular events (MACE)

Timeframe: At 12, 24, 36, 48, and 60 months after discharge

Frequency of occurrence of high-risk plaques

Timeframe: baseline, pre-intervention

CT Fractional Flow Reserve gradient

Timeframe: baseline, pre-intervention

Perivascular Fat Attenuation Index

Timeframe: baseline, pre-intervention

PPG derived by follow up CCTA

Timeframe: baseline, pre-intervention

SYNTAX score

Timeframe: immediately after the intervention

Coronary Angiography-derived FFR and Coronary Angiography-derived Index of Microcirculatory Resistance

Timeframe: baseline, pre-intervention