Coronary Artery Disease, Immune Thrombocytopenic Purpura
Conditions
Keywords
immune thrombocytopenia, coronary artery disease, coronary revascularization, prognostic model, MACE
Brief summary
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.
Detailed description
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.
Interventions
None listed
Sponsors
Xiao Hui Zhang
Chinese Academy of Medical Sciences, Fuwai Hospital
Beijing Anzhen Hospital
Peking University Third Hospital
Chinese PLA General Hospital
Peking Union Medical College
Study design
Observational model
COHORT
Time perspective
PROSPECTIVE
Eligibility
Sex/Gender
ALL
Age
18 Years to 90 Years
Healthy volunteers
No
Inclusion criteria
1. Age ≥ 18 years. 2. Diagnosis of primary Immune Thrombocytopenia (ITP) according to international working group criteria. 3. Diagnosis of Coronary Artery Disease (stable angina or Acute Coronary Syndrome) confirmed by coronary angiography. 4. The diagnosis of ITP must be established and documented prior to the diagnosis of CAD. 5. Capable of providing informed consent (for prospective enrollment and data collection).
Exclusion criteria
1. Secondary causes of thrombocytopenia (e.g., drug-induced, hematologic malignancy, hypersplenism, liver disease). 2. Conditions requiring long-term therapeutic anticoagulation (e.g., atrial fibrillation, mechanical heart valve). 3. Life expectancy less than 1 year due to non-cardiovascular disease. 4. Inability to comply with follow-up. 5. Inability to give informed consent. 6. Pregnancy or breastfeeding. 7. A history of Type 2 Myocardial Infarction prior to the index treatment decision.
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| 1-year incidence of Major Adverse Cardiovascular Events (MACE) | from the date of CAD diagnosis (index date) until 1 year of follow-up | 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. |
| 1-month incidence of Major Adverse Cardiovascular Events (MACE) | from the date of CAD diagnosis (index date) until 1 month of follow-up | 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. |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| overall bleeding event | from the date of CAD diagnosis (index date) until 1 month and 1 year of follow-up | the bleeding event identified according to the BARC standardized bleeding Criteria |
| Hospitalization for CAD within 1 year. | from the date of CAD diagnosis (index date) until 1 year of follow-up | Hospitalization for CAD within 1 year. |
| key predictors of adverse outcomes following revascularization | from the date of CAD diagnosis (index date) until 1 month and 1 year of follow-up | 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. |
| BARC type ≥2 bleeding event | from the date of CAD diagnosis (index date) until 1 month and 1 year of follow-up | clinical-related bleeding with a BARC type ≥2 bleeding event |
| 1-year overall survival | from the date of CAD diagnosis (index date) until 1 year of follow-up | overall survival from the date of CAD diagnosis (index date) until 1 year of follow-up |
Contacts
CONTACTJin Wu
CONTACTYe-Jun Wu
Outcome results
None listed