Premature Coronary Heart Disease
Conditions
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.
Interventions
None listed
Sponsors
China National Center for Cardiovascular Diseases
Study design
Observational model
COHORT
Time perspective
PROSPECTIVE
Eligibility
Sex/Gender
ALL
Age
18 Years to 45 Years
Healthy volunteers
No
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).
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| MACCE, defined as a composite of cardiac death, MI, ischemic stroke, and repeat revascularization | 2 years | — |
| Sensitivity for 2-year MACCE prediction | 2 years | For the validation cohort |
| Specificity for 2-year MACCE prediction | 2 years | For the validation cohort |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Incidence of definite or probable stent thrombosis during the acute, subacute, late, and very late phase according to the ARC-2 criteria | 2 years | For the development cohort |
| Incidence of stroke (ischemic and hemorrhagic stroke) at 1 m, 6 m, 1 y and 2 y | 2 years | For the development cohort |
| Incidence of bleeding events defined as BARC type ≥2 at 1 m, 6 m, 1 y and 2 y | 2 years | For the development cohort |
| Incidence of death (cardiovascular, noncardiovascular, and undetermined) at 1 m, 6 m, 1 y and 2 y | 2 years | For the development cohort |
| Positive predictive value (PPV) | 2 years | For the validation cohort |
| Negative predictive value (NPV) | 2 years | For the validation cohort |
| Area under the ROC curve (AUC) | 2 years | For the validation cohort |
| 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 | 2 years | For the development cohort |
| 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 | 2 years | For the development cohort |
Countries
China
Contacts
Primary ContactJingjing Xu
Outcome results
None listed