About this trial
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.
Eligibility criteria
This trial does not accept healthy volunteersQualifiers
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.
Disqualifiers
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.
Trial population
Retrospective Development/Training Cohort: This cohort will include eligible patients identified from the past medical records of participating centers. Data on their treatment (revascularization or medical therapy) and long-term outcomes will be collected retrospectively. This cohort serves primarily for predictor identification and initial model development/training. Prospective Validation Cohort: This cohort will consist of consecutive, eligible patients newly identified at participating centers following study initiation. They will be managed according to standard clinical practice and followed forward in time for outcome events. This cohort is dedicated to the external validation and performance testing of the prediction model derived from the retrospective cohort.
Trial design
Cohort
Prospective
Treatments tested in this trial
Not listed
Trial groups
Trial outcomes
Primary outcomes
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.
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.
Secondary outcomes
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.
BARC type ≥2 bleeding event
clinical-related bleeding with a BARC type ≥2 bleeding event
overall bleeding event
the bleeding event identified according to the BARC standardized bleeding Criteria
Hospitalization for CAD within 1 year.
Hospitalization for CAD within 1 year.
Other outcomes
Performance of the AI-based model in predicting Major Adverse Cardiovascular Events (MACE)
Assessment of the discriminative power and calibration of the AI-based prognostic model for predicting MACE in the validation cohort. Discrimination will be quantified using the Area Under the Receiver Operating Characteristic Curve (AUC) or C-statistic. Calibration will be assessed using a calibration plot and the Hosmer-Lemeshow goodness-of-fit test.MACE is defined as a composite of all-cause death, non-fatal myocardial infarction, urgent coronary revascularization and ischemic stroke.
Subgroup analysis: Impact of clinical factors on MACE incidence
Incidence rates (number and proportion of events) of MACE will be calculated for subgroups stratified by pre-defined clinical factors. These factors include type of Coronary Artery Disease (Stable CAD vs. Acute Coronary Syndrome \[ACS\]), platelet count categories (e.g., \<25×10⁹/L, 25-50×10⁹/L, \>50×10⁹/L), age, and sex. Furthermore, the association between these factors and MACE will be evaluated using multivariate Cox proportional hazards or logistic regression models, reported as adjusted Hazard Ratios (HR) with 95% confidence intervals. MACE is defined as a composite of all-cause death, non-fatal myocardial infarction, urgent coronary revascularization and ischemic stroke.
Locations
Sponsors and contacts
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Xiao Hui Zhang
Lead sponsor
Peking University People's Hospital
Sponsor institution
Chinese Academy of Medical Sciences, Fuwai Hospital
Collaborator
Beijing Anzhen Hospital
Collaborator
Peking University Third Hospital
Collaborator
Chinese PLA General Hospital
Collaborator
Peking Union Medical College
Collaborator
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