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

February 15, 2026 updated by: Xiao Hui Zhang

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)

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 Overview

Status

Not yet recruiting

Conditions

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.

Study Type

Observational

Enrollment (Estimated)

600

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

Study Contact Backup

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

  • Adult
  • Older Adult

Accepts Healthy Volunteers

No

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.

Description

Inclusion Criteria:

  1. Age ≥ 18 years.
  2. Diagnosis of primary Immune Thrombocytopenia (ITP) according to international working group criteria.
  3. Diagnosis of Coronary Artery Disease (stable angina or Acute Coronary Syndrome) confirmed by coronary angiography.
  4. The diagnosis of ITP must be established and documented prior to the diagnosis of CAD.
  5. Capable of providing informed consent (for prospective enrollment and data collection).

Exclusion Criteria:

  1. Secondary causes of thrombocytopenia (e.g., drug-induced, hematologic malignancy, hypersplenism, liver disease).
  2. Conditions requiring long-term therapeutic anticoagulation (e.g., atrial fibrillation, mechanical heart valve).
  3. Life expectancy less than 1 year due to non-cardiovascular disease.
  4. Inability to comply with follow-up.
  5. Inability to give informed consent.
  6. Pregnancy or breastfeeding.
  7. A history of Type 2 Myocardial Infarction prior to the index treatment decision.

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

Cohorts and Interventions

Group / Cohort
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

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
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
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)
Time Frame: from the date of CAD diagnosis (index date) until 1 year of follow-up
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 Outcome Measures

Outcome Measure
Measure Description
Time Frame
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
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.
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
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
Time Frame: from the date of CAD diagnosis (index date) until 1 month and 1 year of follow-up
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.
Time Frame: from the date of CAD diagnosis (index date) until 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
Time Frame: from the date of CAD diagnosis (index date) until 1 year of follow-up
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

Other Outcome Measures

Outcome Measure
Measure Description
Time Frame
Performance of the AI-based model in predicting Major Adverse Cardiovascular Events (MACE)
Time Frame: from the date of CAD diagnosis (index date) until 1 month and 1 year of follow-up
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.
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
Time Frame: from the date of CAD diagnosis (index date) until 1 month and 1 year of follow-up
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

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Xiao Hui Zhang

Collaborators

Chinese PLA General Hospital
Peking University Third Hospital
Beijing Anzhen Hospital
Chinese Academy of Medical Sciences, Fuwai Hospital
Peking Union Medical College

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Estimated)

February 25, 2026

Primary Completion (Estimated)

February 25, 2028

Study Completion (Estimated)

February 25, 2029

Study Registration Dates

First Submitted

December 17, 2025

First Submitted That Met QC Criteria

February 15, 2026

First Posted (Actual)

February 23, 2026

Study Record Updates

Last Update Posted (Actual)

February 23, 2026

Last Update Submitted That Met QC Criteria

February 15, 2026

Last Verified

February 1, 2026

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • The ITP-CAD AI-REVASC Study

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

UNDECIDED

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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