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NCT Number: NCT07004452

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

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Key information

Conditions

Premature Coronary Heart Disease

Age range

18 year–45 year

Sex eligibility

All sexes

Study type

Observational

Primary location

FuWai Hospital

Beijing, China

Location status: Recruiting

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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).

Treatment and study plan

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

    Time frame: 2 years

    For the validation cohort

  3. Specificity for 2-year MACCE prediction

    Time frame: 2 years

    For the validation cohort

Secondary outcomes

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

    Time frame: 2 years

    For the development cohort

  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

    Time frame: 2 years

    For the development cohort

  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

    Time frame: 2 years

    For the development cohort

  4. 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

    For the development cohort

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

    Time frame: 2 years

    For the development cohort

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

    Time frame: 2 years

    For the development cohort

  7. Area under the ROC curve (AUC)

    Time frame: 2 years

    For the validation cohort

  8. Positive predictive value (PPV)

    Time frame: 2 years

    For the validation cohort

  9. Negative predictive value (NPV)

    Time frame: 2 years

    For the validation cohort

Study contacts

Contact information is provided by the study sponsor or research team.

Jingjing Xu

CONTACT

[email protected]

86 134-260-50924

Sponsors and collaborators

Lead sponsor

China National Center for Cardiovascular Diseases

Other Gov

Registry information

Important dates

Study start
2025
Primary completion
2027
Study completion
2027
First posted
Jun 4, 2025
Registry last updated
Jun 4, 2025

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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