Using AI to predict acute coronary syndrome from white blood cell data

Is this trial a fit for you?

A plain-English reading of the study's rules. Only the study team can confirm whether you qualify.

What this trial studies

This observational study aims to evaluate whether artificial intelligence (AI) can accurately predict acute coronary syndrome (ACS) by analyzing white blood cell (WBC) properties in adults. The study will compare the predictive accuracy of AI algorithms against traditional high-sensitivity cardiac troponin (hs-cTn) blood tests. Participants will have their previously collected health information and blood test results utilized to train and test the AI models, without undergoing any new procedures. The study is conducted at the Medical University of Graz and involves a prospective, observational case-control design.

Why it matters

Who can join: the full rules

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 hs-cTn data must be fulfilled.

Supplementary cohort:

* Subject presents without chest pain or with stable angina pectoris.
* No indication for revascularization during coronary angiography; identical evaluation results by review board required.
* Exclusion of elevated hs-cTn.
* Criteria for timing of blood sampling for collection of WBC and hs-cTn data must be fulfilled.
* Between initial blood sampling to collect WBC data and coronary angiography, the subject must not develop suspicion of ACS.

Rule-out cohort:

* Suspicion of NSTE-ACS and NSTEMI rule-out according to current ESC guidelines, i.e. very low initial hs-cTn value, or low initial hs-cTn value and no significant 1-hour/2-hour change in hs-cTn value.
* No coronary angiography within 72 hours.
* Criteria for timing of blood sampling for collection of WBC and hs-cTn data must be fulfilled.

All-comer cohort:

* Subject presents to the emergency department with suspected ACS.
* Clinical assessments, ECG, and measurements of hs-cTn, single or serial measurement, must be conducted according to ESC guidelines.
* Collection of WBC data must be performed at initial blood withdrawal after admission to the emergency department.
* Review board evaluations must confirm the presence or absence of a culprit lesion if coronary angiography was performed, as outlined for the case and control cohorts.

Exclusion Criteria:

* Age below 18 years.
* Subject refuses informed consent.
* Collection of WBC and hs-cTn data is not possible.
* Criteria for timing of blood sampling for collection of WBC and hs-cTn data cannot be fulfilled.
* Suspicion of ACS occurs in subjects with no or stable angina pectoris any time between initial blood sampling and start of coronary angiography.

Where it's running

• Landeskrankenhaus-Universitätsklinikum Graz
  Graz, Styria / Steiermark, Austria Recruiting

Study contacts

• Study coordinator: Dimitrij Shulkin, M.Sc.
• Email: shulkin@robotdreams.co
• Phone: +43-676-5150578

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How to take part

1. Review the eligibility criteria above with your treating physician.
2. Check the official listing on ClinicalTrials.gov for the latest contact details and recruitment status.
3. Contact the study coordinator or principal investigator to ask for pre-screening. Pre-screening is free and never obligates you to enroll.