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
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 design
Treatments tested in this trial
- Not listed
Trial groups
600 Participants
are grouped into 2 trial groupsLocations
Sponsors and collaborators
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
Source ClinicalTrials.gov