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

NCT07004452 | Recruiting

• 1 other identifier: 2023ZD0504003
• Study Type: observational
• Target: 5,000
• Locations: 1 country
• Sites: 1

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.

Conditions

Premature Coronary Heart Disease

Outcome Measures

Primary Outcomes (3)

• MACCE, defined as a composite of cardiac death, MI, ischemic stroke, and repeat revascularization

  2 years

• Sensitivity for 2-year MACCE prediction

  For the validation cohort

  2 years

• Specificity for 2-year MACCE prediction

  For the validation cohort

  2 years

Secondary Outcomes (9)

• Incidence of death (cardiovascular, noncardiovascular, and undetermined) at 1 m, 6 m, 1 y and 2 y

  2 years

• 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

• 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

• Incidence of definite or probable stent thrombosis during the acute, subacute, late, and very late phase according to the ARC-2 criteria

  2 years

• Incidence of stroke (ischemic and hemorrhagic stroke) at 1 m, 6 m, 1 y and 2 y

  2 years

Eligibility Criteria

• Age: 18 Years - 45 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64)
• Sampling Method: Probability Sample

Study Population

Eligible participants are CAD patients aged 18-45 years confirmed by coronary angiography or other imaging modalities, including those with stable/unstable angina or myocardial infarction.

You may qualify if:

• 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.

You may not qualify if:

• 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).

Sponsors & Collaborators

• China National Center for Cardiovascular Diseases: lead

Study Sites (1)

FuWai Hospital

Beijing, China

RECRUITING

Central Study Contacts

Jingjing Xu

CONTACT

86 134-260-50924; 335418449@qq.com

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: PROSPECTIVE
• Sponsor Type: OTHER GOV
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: May 27, 2025
• First Posted: June 4, 2025
• Study Start: March 31, 2025
• Primary Completion (Estimated): July 1, 2027
• Study Completion (Estimated): July 1, 2027
• Last Updated: June 4, 2025

Record last verified: 2025-05

Locations

CN (1)