Diagnostic Performance of Artificial Intelligence Algorithms in Prediction of Acute Coronary Synd… (NCT06384846) | Clinical Trial Compass
RecruitingNot Applicable
Diagnostic Performance of Artificial Intelligence Algorithms in Prediction of Acute Coronary Syndrome Based on White Blood Cell Properties
Austria3,350 participantsStarted 2024-02-01
Plain-language summary
The goal of this observational study is to evaluate whether artificial intelligence (AI) algorithms can predict or exclude acute coronary syndrome (ACS) in adults using data generated by routine hematology testing. The main questions the study aims to answer are:
* Can AI algorithms based on white blood cell (WBC) data predict or exclude ACS in subjects with suspected ACS?
* Can erythrocyte (EC) and/or thrombocyte (TC) data, where available, improve or complement WBC-based AI prediction of ACS?
* How does the diagnostic performance of the AI algorithms compare with high-sensitivity cardiac troponin (hs-cTn), and can the combination of AI algorithms and hs-cTn improve diagnostic performance?
Participants will undergo clinical assessment and blood testing as part of usual clinical care. Their previously generated clinical information, hematology data, and hs-cTn results will be used to train and test the AI algorithms. Participation in the study does not determine the indication for coronary angiography or treatment, and no additional study-specific treatments are performed.
Who can participate
Age range
18 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:
General inclusion criteria:
* Male or female, aged 18 years or above.
* Participant is willing and able to give informed consent for participation in the study.
* Collection of WBC and hs-cTn data must be possible.
* Criteria for timing of blood sampling for collection of WBC and hs-cTn data must be fulfilled, where applicable.
Case cohort:
* Suspicion of STEMI or NSTE-ACS according to current ESC guidelines.
* Coronary angiography must have been performed within 72 hours after initial suspicion of ACS.
* For patients qualifying for observation according to ESC guidelines, coronary angiography is not mandatory and time limits do not apply.
* Confirmation of STEMI or NSTE-ACS by identification of a culprit lesion using coronary angiography; identical evaluation results by review board required.
* For observation patients without coronary angiography, final discharge diagnosis is used to decide about the presence or absence of NSTEMI and/or ACS.
* Criteria for timing of blood sampling for collection of WBC and hs-cTn data must be fulfilled.
Control cohort:
* Suspicion of STEMI or NSTE-ACS according to current ESC guidelines.
* Coronary angiography must have been performed within 72 hours after initial suspicion of ACS.
* No identification of a culprit lesion compatible with diagnosis of STEMI or NSTE-ACS during coronary angiography; identical evaluation results by review board required.
* Criteria for timing of blood sampling for collection of WBC and …
Questions worth asking your doctor
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.
1Based on my diagnosis and history, is this trial worth exploring for me — or is there a standard treatment we should try first?
2What does this trial's phase tell us about how much is already known about its safety and benefit?
3What would taking part actually involve for me — visits, tests, time, and travel?
4What are the known and possible risks or side effects I should weigh, and how would they be monitored?
5If this trial isn't the right fit, what other options or trials would you suggest I look into?
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.