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

Trial statusNot yet recruiting
Trial phaseNot listed
Trial typeObservational
Biological sexAll
Age18-90
SponsorXiao Hui Zhang

About this trial

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.

Eligibility criteria

This trial does not accept healthy volunteers

Qualifiers

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.

Disqualifiers

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.

Trial 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.

Trial design

Design model

Cohort

Time perspective

Prospective

Treatments tested in this trial

Not listed

Trial groups

600 Participants
are grouped into 2 trial groups
Group A: Revascularization Group
Group B: Medical Therapy Group

Trial outcomes

Primary outcomes

1

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.

Time frame
from the date of CAD diagnosis (index date) until 1 month of follow-up
2

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.

Time frame
from the date of CAD diagnosis (index date) until 1 year of follow-up

Secondary outcomes

1

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.

Time frame
from the date of CAD diagnosis (index date) until 1 month and 1 year of follow-up
2

BARC type ≥2 bleeding event

clinical-related bleeding with a BARC type ≥2 bleeding event

Time frame
from the date of CAD diagnosis (index date) until 1 month and 1 year of follow-up
3

overall bleeding event

the bleeding event identified according to the BARC standardized bleeding Criteria

Time frame
from the date of CAD diagnosis (index date) until 1 month and 1 year of follow-up
4

Hospitalization for CAD within 1 year.

Hospitalization for CAD within 1 year.

Time frame
from the date of CAD diagnosis (index date) until 1 year of follow-up

Other outcomes

1

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.

Time frame
from the date of CAD diagnosis (index date) until 1 month and 1 year of follow-up
2

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.

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

Locations

This trial has no locations.

Sponsors and contacts

Click on the lead sponsor to view all of their trials.

Xiao Hui Zhang

Lead sponsor

Peking University People's Hospital

Sponsor institution

Chinese Academy of Medical Sciences, Fuwai Hospital

Collaborator

Beijing Anzhen Hospital

Collaborator

Peking University Third Hospital

Collaborator

Chinese PLA General Hospital

Collaborator

Peking Union Medical College

Collaborator

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