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

Trial statusRecruiting
Trial phaseNot listed
Trial typeObservational
Biological sexAll
Age18-45
SponsorChina National Center for Cardiovascular Diseases

About this trial

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.

Eligibility criteria

This trial does not accept healthy volunteers

Qualifiers

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.

Disqualifiers

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).

Trial 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.

Trial design

Design model

Cohort

Time perspective

Prospective

Treatments tested in this trial

Not listed

Trial groups

No trial groups listed

Trial outcomes

Primary outcomes

1

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

Time frame
2 years
2

Sensitivity for 2-year MACCE prediction

For the validation cohort

Time frame
2 years
3

Specificity for 2-year MACCE prediction

For the validation cohort

Time frame
2 years

Secondary outcomes

1

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

For the development cohort

Time frame
2 years
2

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

For the development cohort

Time frame
2 years
3

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

For the development cohort

Time frame
2 years
4

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

For the development cohort

Time frame
2 years

Other outcomes

Sponsors and contacts

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