Clinical trial NCT07004452: Multi-modal Adverse Events Prediction for Premature Coronary Heart Disease Trial: MAP-CHD Trial
Official title: Multi-modal Adverse Events Prediction for Premature Coronary Heart Disease Trial: MAP-CHD Trial
Study type: OBSERVATIONAL
Overall status: RECRUITING
Conditions: Premature Coronary Heart Disease
Lead sponsor: China National Center for Cardiovascular Diseases
Sponsor class: OTHER_GOV
First posted: 2025-06-04
Enrollment: 5000
Sex: ALL
Minimum age (years): 18
Maximum age (years): 45
Standard ages: ADULT
Accepts healthy volunteers: no
Observational model: COHORT
Time perspective: PROSPECTIVE
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.

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.


Eligibility criteria: 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).

Primary outcomes:
measure: MACCE, defined as a composite of cardiac death, MI, ischemic stroke, and repeat revascularization
timeFrame: 2 years
measure: Sensitivity for 2-year MACCE prediction
timeFrame: 2 years
measure: Specificity for 2-year MACCE prediction
timeFrame: 2 years
Secondary outcomes:
measure: Incidence of death (cardiovascular, noncardiovascular, and undetermined) at 1 m, 6 m, 1 y and 2 y
timeFrame: 2 years
measure: 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
timeFrame: 2 years
measure: 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
timeFrame: 2 years
measure: Incidence of definite or probable stent thrombosis during the acute, subacute, late, and very late phase according to the ARC-2 criteria
timeFrame: 2 years
measure: Incidence of stroke (ischemic and hemorrhagic stroke) at 1 m, 6 m, 1 y and 2 y
timeFrame: 2 years
measure: Incidence of bleeding events defined as BARC type ≥2 at 1 m, 6 m, 1 y and 2 y
timeFrame: 2 years
measure: Area under the ROC curve (AUC)
timeFrame: 2 years
measure: Positive predictive value (PPV)
timeFrame: 2 years
measure: Negative predictive value (NPV)
timeFrame: 2 years
Other outcomes:
Locations:
city: Beijing
country: China
facility: FuWai Hospital
Study officials:
References: