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Not yet recruiting NCT07426107

Development and Prospective Validation of an AI Model for Prognosis in ITP Patients Undergoing Coronary Revascularization

— Observational Immune Thrombocytopenic Purpura Coronary Artery Disease

For patients and families

In plain language

An automatic summary of structured registry data. It is an orientation aid, not a substitute for the official protocol or a physician assessment.

What is being studied
This is an observational study: the protocol does not assign a study treatment.
Who it may be relevant to
Registry conditions: Immune Thrombocytopenic Purpura, Coronary Artery Disease. Basic parameters: 18 years — 90 years · All.
What needs checking
Age, condition and sex are only basic indicators. Prior treatment, laboratory values and other mandatory requirements appear in the eligibility criteria below.
Where it takes place
Center list to be confirmed — check the primary protocol.
Next step
Save the trial, show it to the treating physician, and confirm current recruitment with the study center. Costs, documents and travel →

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Official title

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)

Overview

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.

Primary outcome measures

  • 1-month incidence of Major Adverse Cardiovascular Events (MACE) [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) [Time frame: from the date of CAD diagnosis (index date) until 1 year of follow-up]
Secondary outcome measures (5)
  • key predictors of adverse outcomes following revascularization [Time frame: from the date of CAD diagnosis (index date) until 1 month and 1 year of follow-up]
  • 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 [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. [Time frame: from the date of CAD diagnosis (index date) until 1 year of follow-up]
  • 1-year overall survival [Time frame: from the date of CAD diagnosis (index date) until 1 year of follow-up]

Eligibility criteria

Inclusion criteria

  • 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).

Exclusion criteria

  • 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.

Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.

Healthy volunteers: No

Study design

Observational model
Cohort

Study locations

Center list to be confirmed — check the primary protocol.

Identifiers

NCT: NCT07426107 · The ITP-CAD AI-REVASC Study

Primary sources (government registries)

View this study on ClinicalTrials.gov ↗