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

China National Center for Cardiovascular Diseases5,000 enrolled

Overview

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.

Study Type

OBSERVATIONAL

Enrollment

5,000

Conditions

Premature Coronary Heart Disease

Eligibility

Sex: ALLMin age: 18 YearsMax age: 45 Years

Medical Language ↔ Plain English

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).

Locations (1)

Outcomes

Primary Outcomes

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

Time frame: 2 years

Sensitivity for 2-year MACCE prediction

For the validation cohort

Time frame: 2 years

Specificity for 2-year MACCE prediction

For the validation cohort

Time frame: 2 years

Secondary Outcomes

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

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

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

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

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

For the development cohort

Time frame: 2 years

Incidence of bleeding events defined as BARC type ≥2 at 1 m, 6 m, 1 y and 2 y

For the development cohort

Time frame: 2 years

Area under the ROC curve (AUC)

For the validation cohort

Time frame: 2 years

Positive predictive value (PPV)

For the validation cohort

Time frame: 2 years

Negative predictive value (NPV)

For the validation cohort

Time frame: 2 years

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

Overview

Conditions

Eligibility

Locations (1)

Outcomes

Primary Outcomes

Secondary Outcomes

Central Contacts