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

NCT07426107 | Not Yet Recruiting DMC

• 1 other identifier: The ITP-CAD AI-REVASC Study
• Study Type: observational
• Target: 600
• Locations: 0 countries
• Sites: N/A

Brief 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.

Conditions

Immune Thrombocytopenic Purpura; Coronary Artery Disease

Keywords

immune thrombocytopenia; coronary artery disease; coronary revascularization; prognostic model; MACE

Outcome Measures

Primary Outcomes (2)

• 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

Secondary Outcomes (5)

• 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

Other Outcomes (2)

• Performance of the AI-based model in predicting Major Adverse Cardiovascular Events (MACE)

  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

  from the date of CAD diagnosis (index date) until 1 month and 1 year of follow-up

Study Arms (2)

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

Eligibility Criteria

• Age: 18 Years - 90 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)
• Sampling Method: Non-Probability Sample

Study 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.

You may qualify if:

• 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).

You may not qualify if:

• 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.

Sponsors & Collaborators

• Peking University Third Hospital: collaborator
• Xiao Hui Zhang: lead
• Chinese Academy of Medical Sciences, Fuwai Hospital: collaborator
• Beijing Anzhen Hospital: collaborator
• Chinese PLA General Hospital: collaborator
• Peking Union Medical College: collaborator

MeSH Terms

Conditions

Purpura, Thrombocytopenic, Idiopathic; Coronary Artery Disease

Condition Hierarchy (Ancestors)

Purpura, Thrombocytopenic; Purpura; Blood Coagulation Disorders; Hematologic Diseases; Hemic and Lymphatic Diseases; Thrombotic Microangiopathies; Thrombocytopenia; Blood Platelet Disorders; Cytopenia; Hemorrhagic Disorders; Autoimmune Diseases; Immune System Diseases; Hemorrhage; Pathologic Processes; Pathological Conditions, Signs and Symptoms; Skin Manifestations; Signs and Symptoms; Coronary Disease; Myocardial Ischemia; Heart Diseases; Cardiovascular Diseases; Arteriosclerosis; Arterial Occlusive Diseases; Vascular Diseases

Central Study Contacts

Jin Wu

CONTACT

010-17888838056; wujin1996@126.com

Ye-Jun Wu

CONTACT

010-18800181620; wyejun1999@163.com

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: PROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: SPONSOR INVESTIGATOR
• PI Title: Professor

Study Record Dates

• First Submitted: December 17, 2025
• First Posted: February 23, 2026
• Study Start: February 25, 2026
• Primary Completion (Estimated): February 25, 2028
• Study Completion (Estimated): February 25, 2029
• Last Updated: February 23, 2026

Record last verified: 2026-02