Health TrialsbyHealthPanel

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

ConditionCoronary Artery Disease (CAD) (E.G., Angina, Myocardial Infarction, and Atherosclerotic Heart Disease (ASHD))
Trial statusNot yet recruiting
Trial phaseNot listed
Trial typeObservational
Biological sexAll
Age18+
SponsorBeijing Anzhen Hospital

About this trial

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.

Eligibility criteria

This trial does not accept healthy volunteers

Qualifiers

None

Disqualifiers

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.

Trial population

Suspected CAD patients underwent CCTA

Trial design

Design model

Cohort

Time perspective

Other

Treatments tested in this trial

Not listed

Trial groups

10,960 Participants
are grouped into 2 trial groups
Group A: retrospective cohort
Group B: prospective cohort

Trial outcomes

Primary outcomes

1

The composite endpoint of major adverse cardiovascular events (MACE)

including cardiac death, non-fatal myocardial infarction, and rehospitalization for unstable angina or heart failure.

Time frame
At 12, 24, 36, 48, and 60 months after discharge
2

Frequency of occurrence of high-risk plaques

Frequency (%) of occurrence of high-risk plaque morphologic features (ow-attenuation plaques, positive remodeling, spotty calcification, and the napkin-ring sign, minimal lumen area\[MLA\]\<4mm2)

Time frame
baseline, pre-intervention
3

CT Fractional Flow Reserve gradient

The CT-FFR gradient is defined as the peak instantaneous CT-FFR gradient per unit vessel length, serving as an indicator of local lesion severity. The calculation of the CT-FFR gradient was performed only for lesions with diameter stenosis \> 30%.

Time frame
baseline, pre-intervention
4

Perivascular Fat Attenuation Index

The Fat Attenuation Index (FAI) was defined as the mean attenuation of perivascular adipose tissue (PVAT). The density range of adipose tissue included in the analysis was restricted to -190 HU to -30 HU, and the FAI surrounding the target vessel was automatically calculated by the software.

Time frame
baseline, pre-intervention

Secondary outcomes

Other outcomes

Sponsors and contacts

Click on the lead sponsor to view all of their trials.

Beijing Anzhen Hospital

Lead sponsor

Source ClinicalTrials.gov

This trial is not recruiting at the moment. You can still explore other options: