Multi-modal Adverse Events Prediction for Premature Coronary Heart Disease Trial: MAP-CHD Trial

Recruiting

• Conditions: Premature Coronary Heart Disease

• Registration Number: NCT07004452
• Lead Sponsor: China National Center for Cardiovascular Diseases

Brief Summary

The goal of this observational cohort study is to establish a risk prediction model for adverse events in Chinese individuals under 45 years old with premature coronary artery disease. The main questions it aims to answer are:

* What are the major risk factors for poor prognosis in Chinese patients with premature coronary artery disease?

* What is the difference in the prognosis of patients with premature coronary heart disease with different phenotypes? Participants taking no mandatory intervention will be followed up for 2 year, with blood tests at 1 year and outpatient or telephone interviews at other timepoints.

Detailed Description

Not available

Study Timeline

• Study Start: 2025-03-31
• Status Verified: 2025-05
• Study First Submitted: 2025-05-27
• Study First Submitted QC: 2025-05-27
• Last Update Submitted: 2025-05-27
• Study First Posted: 2025-06-04
• Last Update Posted: 2025-06-04
• Primary Completion: 2027-07
• Study Completion: 2027-07

Recruitment & Eligibility

• Status: RECRUITING
• Sex: All
• Target Recruitment: 5000

Inclusion Criteria

• Age 18-45 years;
• Clinically confirmed CAD with ≥50% luminal stenosis in at least one major coronary artery or significant branch, verified by coronary angiography;
• For acute coronary syndrome (ACS) or percutaneous coronary intervention (PCI) patients: clinical stability meeting discharge criteria post-treatment;
• Voluntary participation with signed informed consent.

Exclusion Criteria

• Heart transplant recipients;
• Severe systemic comorbidities with life expectancy <1 year;
• Previous enrollment in other drug/device clinical trials without completing the primary endpoint observation period;
• Inability to comply with follow-up (e.g., dementia, severe psychiatric disorders).

Study & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
MACCE, defined as a composite of cardiac death, MI, ischemic stroke, and repeat revascularization	2 years
Sensitivity for 2-year MACCE prediction	2 years	For the validation cohort
Specificity for 2-year MACCE prediction	2 years	For the validation cohort

Secondary Outcome Measures

Name	Time	Method
Incidence of death (cardiovascular, noncardiovascular, and undetermined) at 1 m, 6 m, 1 y and 2 y	2 years	For the development cohort
Incidence of MI (target vessel related and non-target vessel related or Culprit and non-culprit lesion-related) at 1 m, 6 m, 1 y and 2 y	2 years	For the development cohort
Incidence of all revascularizations (ischemia driven vs. non-ischemia driven; Target vs. non-target vessel; Culprit vs. non-culprit lesion) at 1 m, 6 m, 1 y and 2 y	2 years	For the development cohort
Incidence of definite or probable stent thrombosis during the acute, subacute, late, and very late phase according to the ARC-2 criteria	2 years	For the development cohort
Incidence of stroke (ischemic and hemorrhagic stroke) at 1 m, 6 m, 1 y and 2 y	2 years	For the development cohort
Incidence of bleeding events defined as BARC type ≥2 at 1 m, 6 m, 1 y and 2 y	2 years	For the development cohort
Area under the ROC curve (AUC)	2 years	For the validation cohort
Positive predictive value (PPV)	2 years	For the validation cohort
Negative predictive value (NPV)	2 years	For the validation cohort

Trial Locations

Locations (1)

FuWai Hospital; 🇨🇳 Beijing, China