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| Name | Class |
|---|---|
| Chinese Academy of Medical Sciences, Fuwai Hospital | OTHER |
| Beijing Anzhen Hospital | OTHER |
| Peking University Third Hospital | OTHER |
| Chinese PLA General Hospital |
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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:
Objective: To compare MACE risk between groups and to develop and validate a model predicting MACE specifically in the revascularization group.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| 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 |
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| Measure | Description | Time Frame |
|---|---|---|
| 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. | 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. | from the date of CAD diagnosis (index date) until 1 year of follow-up |
| Measure | Description | Time Frame |
|---|---|---|
| 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. |
| Measure | Description | Time Frame |
|---|---|---|
| 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. |
Inclusion Criteria:
Exclusion Criteria:
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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.
| Name | Role | Phone | Extension | |
|---|---|---|---|---|
| Jin Wu | Contact | 010-17888838056 | wujin1996@126.com | |
| Ye-Jun Wu | Contact | 010-18800181620 | wyejun1999@163.com |
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| ID | Term |
|---|---|
| D016553 | Purpura, Thrombocytopenic, Idiopathic |
| D003324 | Coronary Artery Disease |
| ID | Term |
|---|---|
| D011696 | Purpura, Thrombocytopenic |
| D011693 | Purpura |
| D001778 | Blood Coagulation Disorders |
| D006402 | Hematologic Diseases |
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| OTHER |
| Peking Union Medical College | OTHER |
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| 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 | 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 | 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. | 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 | from the date of CAD diagnosis (index date) until 1 year of follow-up |
| from the date of CAD diagnosis (index date) until 1 month and 1 year of follow-up |
| 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. | from the date of CAD diagnosis (index date) until 1 month and 1 year of follow-up |
| D006425 |
| Hemic and Lymphatic Diseases |
| D057049 | Thrombotic Microangiopathies |
| D013921 | Thrombocytopenia |
| D001791 | Blood Platelet Disorders |
| D000095542 | Cytopenia |
| D006474 | Hemorrhagic Disorders |
| D001327 | Autoimmune Diseases |
| D007154 | Immune System Diseases |
| D006470 | Hemorrhage |
| D010335 | Pathologic Processes |
| D013568 | Pathological Conditions, Signs and Symptoms |
| D012877 | Skin Manifestations |
| D012816 | Signs and Symptoms |
| D003327 | Coronary Disease |
| D017202 | Myocardial Ischemia |
| D006331 | Heart Diseases |
| D002318 | Cardiovascular Diseases |
| D001161 | Arteriosclerosis |
| D001157 | Arterial Occlusive Diseases |
| D014652 | Vascular Diseases |