Development and Prospective Validation of an AI Model for Prognosis in ITP Patients Undergoing Co… (NCT07426107) | Clinical Trial Compass
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 range
18 Years – 90 Years
Sex
ALL
See this in plain English?
AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.
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).
Bring these to your next appointment. They're a starting point for a shared conversation — not a sign you qualify or a recommendation to enrol.
1This trial is about using an AI model to predict outcomes in ITP patients who are having coronary revascularization — does my specific combination of ITP and coronary artery disease make this something worth discussing as part of my care planning?
2Since this study is not yet recruiting, how long might it be before it actually opens, and are there other options I should be pursuing in the meantime while I wait to see if this becomes available?
3The trial is measuring major adverse cardiovascular events at both 1 month and 1 year after revascularization — does that mean my role would mainly be contributing data rather than receiving a new treatment, and how would that affect the direct benefit to me versus future patients?
4Because this is listed as Phase NA and seems focused on developing and validating an AI prediction tool rather than testing a drug or procedure, what would actually be different about my care if I participated compared to receiving standard treatment?
5Given that ITP affects platelet counts and bleeding risk, and that coronary revascularization carries its own bleeding and clotting risks, how does my doctor currently weigh those competing risks for someone like me, and would joining this study change any of those decisions?
Generated to help you prepare — always confirm anything about your own eligibility and care with the study team and your doctor.
Questions for the trial coordinator
The trial coordinator is the person who runs the study day to day. These cover the practical side — logistics, costs, and what taking part would actually mean for your life. The study team confirms whether you meet the criteria; these are questions to ask, not a sign you qualify.
1What does taking part actually involve week to week — how many visits, where, and how long does each one take?
2What costs are covered by the study, and what might I have to pay for myself, including travel, parking, or time off work?
3What happens during screening, and what happens if the study team confirms I don't meet the criteria after those tests?
4Who pays for the scans, blood work, and other tests the trial requires — the study, my insurance, or me?
5How will being in the trial affect my regular care, and will my own doctor stay informed and involved?
6Can I leave the trial at any point if I change my mind, and what would happen to my care if I do?
A starting point for the conversation — always confirm anything about your own eligibility, costs, and care with the study team and your doctor.
What they're measuring
1
1-month incidence of Major Adverse Cardiovascular Events (MACE)
Timeframe: from the date of CAD diagnosis (index date) until 1 month of follow-up
2
1-year incidence of Major Adverse Cardiovascular Events (MACE)
Timeframe: from the date of CAD diagnosis (index date) until 1 year of follow-up