An Artificial Intelligence-Enhanced Longitudinal Cohort Study to Optimize Revascularization Decisions in Patients With Coronary Artery Disease and Immune Thrombocytopenia (The ITP-CAD AI-REVASC Study)
试验速览
- 阶段
- 不适用
- 状态
- 尚未招募
- 发起方
- 入组人数
- 600
- 主要终点
- 1-month incidence of Major Adverse Cardiovascular Events (MACE)
研究概览
简要总结
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.
详细描述
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:
- Revascularization Group: Patients undergoing PCI or CABG.
- 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.
研究设计
- 研究类型
- Observational
- 观察模型
- Cohort
- 时间视角
- Prospective
入排标准
- 年龄范围
- 18 Years 至 90 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Age ≥ 18 years.
- •Diagnosis of primary Immune Thrombocytopenia (ITP) according to international working group criteria.
- •Diagnosis of Coronary Artery Disease (stable angina or Acute Coronary Syndrome) confirmed by coronary angiography.
- •The diagnosis of ITP must be established and documented prior to the diagnosis of CAD.
- •Capable of providing informed consent (for prospective enrollment and data collection).
排除标准
- •Secondary causes of thrombocytopenia (e.g., drug-induced, hematologic malignancy, hypersplenism, liver disease).
- •Conditions requiring long-term therapeutic anticoagulation (e.g., atrial fibrillation, mechanical heart valve).
- •Life expectancy less than 1 year due to non-cardiovascular disease.
- •Inability to comply with follow-up.
- •Inability to give informed consent.
- •Pregnancy or breastfeeding.
- •A history of Type 2 Myocardial Infarction prior to the index treatment decision.
研究组 & 干预措施
Revascularization Group
Coronary artery bypass grafting (CABG) or Percutaneous coronary intervention (PCI) according to standard of care.
Medical Therapy Group
Guideline-directed medical therapy without revascularization
结局指标
主要结局
1-month incidence of Major Adverse Cardiovascular Events (MACE)
时间窗: 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.
1-year incidence of Major Adverse Cardiovascular Events (MACE)
时间窗: 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.
次要结局
- key predictors of adverse outcomes following revascularization(from the date of CAD diagnosis (index date) until 1 month and 1 year of follow-up)
- BARC type ≥2 bleeding event(from the date of CAD diagnosis (index date) until 1 month and 1 year of follow-up)
- overall bleeding event(from the date of CAD diagnosis (index date) until 1 month and 1 year of follow-up)
- Hospitalization for CAD within 1 year.(from the date of CAD diagnosis (index date) until 1 year of follow-up)
- 1-year overall survival(from the date of CAD diagnosis (index date) until 1 year of follow-up)
研究者
Xiao Hui Zhang
Professor
Peking University People's Hospital