This study employs a dual-cohort design to develop and validate a prognostic model for Major Adverse Cardiovascular Events (MACE) following revascularization in immune thrombocytopenia (ITP) patients with Coronary Artery Disease (CAD). The model will be developed and trained using a retrospective multi-center cohort (development/training cohort). Its performance will then be prospectively validated in a separate, consecutively enrolled prospective cohort (validation cohort). The goal is to create an AI-based tool to assist in personalized risk assessment and decision-making for this high-risk population.
Study Design: This is a dual-phase, multi-center observational study. Phase 1 (Retrospective Cohort): A retrospective cohort will serve as the development and training set. Data from eligible patients treated in the past will be collected to identify predictors and develop the initial AI prediction model. Phase 2 (Prospective Cohort): A prospective, observational cohort will serve as the validation set. Consecutively eligible patients will be enrolled and followed forward in time. The model derived from Phase 1 will be applied to this cohort to evaluate its predictive accuracy and clinical utility. Treatment Groups: Within both cohorts, patients will be categorized based on actual clinical care: 1. Revascularization Group: Patients undergoing PCI or CABG. 2. Medical Therapy Group: Patients managed with guideline-directed medical therapy alone. Objective: To compare MACE risk between groups and to develop and validate a model predicting MACE specifically in the revascularization group.
Study Type
OBSERVATIONAL
Enrollment
600
1-month incidence of Major Adverse Cardiovascular Events (MACE)
MACE is a composite endpoint defined as the occurrence of any of the following: all-cause mortality, non-fatal myocardial infarction \[MI\], urgent coronary revascularization \[CRV\] and ischemic stroke. The time frame for assessment is from the date of CAD diagnosis (index date) until 1 month of follow-up.
Time frame: from the date of CAD diagnosis (index date) until 1 month of follow-up
1-year incidence of Major Adverse Cardiovascular Events (MACE)
MACE is a composite endpoint defined as the occurrence of any of the following: all-cause mortality, non-fatal myocardial infarction \[MI\], urgent coronary revascularization \[CRV\] and ischemic stroke. The time frame for assessment is from the date of diagnosis of CAD (index date) until 1 year of follow-up.
Time frame: from the date of CAD diagnosis (index date) until 1 year of follow-up
key predictors of adverse outcomes following revascularization
Identification of independent predictors for MACE in the revascularization group using a multivariate Cox proportional hazards regression model with stepwise selection or Lasso regularization. The model will include candidate clinical variables such as platelet count, type of CAD, comorbidities, and medication use. For each final predictor selected, the Hazard Ratio (HR), 95% confidence interval, and p-value will be reported. MACE is defined as a composite of all-cause death, non-fatal myocardial infarction, urgent coronary revascularization and ischemic stroke.
Time frame: from the date of CAD diagnosis (index date) until 1 month and 1 year of follow-up
BARC type ≥2 bleeding event
clinical-related bleeding with a BARC type ≥2 bleeding event
Time frame: from the date of CAD diagnosis (index date) until 1 month and 1 year of follow-up
overall bleeding event
the bleeding event identified according to the BARC standardized bleeding Criteria
Time frame: from the date of CAD diagnosis (index date) until 1 month and 1 year of follow-up
Hospitalization for CAD within 1 year.
Hospitalization for CAD within 1 year.
Time frame: from the date of CAD diagnosis (index date) until 1 year of follow-up
1-year overall survival
overall survival from the date of CAD diagnosis (index date) until 1 year of follow-up
Time frame: from the date of CAD diagnosis (index date) until 1 year of follow-up
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