Multi-modal Adverse Events Prediction for Premature Coronary Heart Disease Trial: MAP-CHD Trial
For patients and families
In plain language
An automatic summary of structured registry data. It is an orientation aid, not a substitute for the official protocol or a physician assessment.
- What is being studied
- This is an observational study: the protocol does not assign a study treatment.
- Who it may be relevant to
- Registry conditions: Premature Coronary Heart Disease. Basic parameters: 18 years — 45 years · All.
- What needs checking
- Age, condition and sex are only basic indicators. Prior treatment, laboratory values and other mandatory requirements appear in the eligibility criteria below.
- Where it takes place
- China
- Next step
- Save the trial, show it to the treating physician, and confirm current recruitment with the study center. Costs, documents and travel →
Unsure about the terms? Read our patient guide →
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.
Primary outcome measures
- MACCE, defined as a composite of cardiac death, MI, ischemic stroke, and repeat revascularization [Time frame: 2 years]
- Sensitivity for 2-year MACCE prediction [Time frame: 2 years]
- Specificity for 2-year MACCE prediction [Time frame: 2 years]
Secondary outcome measures (9)
- Incidence of death (cardiovascular, noncardiovascular, and undetermined) at 1 m, 6 m, 1 y and 2 y [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 [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 [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 [Time frame: 2 years]
- Incidence of stroke (ischemic and hemorrhagic stroke) at 1 m, 6 m, 1 y and 2 y [Time frame: 2 years]
- Incidence of bleeding events defined as BARC type ≥2 at 1 m, 6 m, 1 y and 2 y [Time frame: 2 years]
- Area under the ROC curve (AUC) [Time frame: 2 years]
- Positive predictive value (PPV) [Time frame: 2 years]
- Negative predictive value (NPV) [Time frame: 2 years]
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).
Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.
Healthy volunteers: No
Study design
- Observational model
- Cohort
Study locations
China · 1 center
- FuWai Hospital — Beijing
Identifiers
NCT: NCT07004452 · 2023ZD0504003