Not Yet RecruitingNot Applicable

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

600 participantsStarted 2026-02-25

Plain-language 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.

Who can participate

Age range18 Years – 90 Years

SexALL

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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.

What they're measuring

1-month incidence of Major Adverse Cardiovascular Events (MACE)

Timeframe: from the date of CAD diagnosis (index date) until 1 month of follow-up

1-year incidence of Major Adverse Cardiovascular Events (MACE)

Timeframe: from the date of CAD diagnosis (index date) until 1 year of follow-up

Trial details

NCT IDNCT07426107

SponsorXiao Hui Zhang

Sponsor typeOTHER

Study typeOBSERVATIONAL

Primary completion2028-02-25

Contact for this trial

Jin Wu

010-17888838056 wujin1996@126.com

View on ClinicalTrials.gov More Immune Thrombocytopenic Purpura trials