NCT06384846 Diagnostic Performance of Artificial Intelligence Algorithms in Prediction of Acute Coronary Syndrome Based on White Blood Cell Properties
| NCT ID | NCT06384846 |
| Status | Recruiting |
| Phase | — |
| Sponsor | RobotDreams GmbH |
| Condition | Acute Coronary Syndrome |
| Study Type | OBSERVATIONAL |
| Enrollment | 3,350 participants |
| Start Date | 2024-02-01 |
| Primary Completion | 2026-07-31 |
Eligibility & Interventions
Eligibility Fast-Check
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What to Expect as a Participant
This is an observational study. You will not receive an experimental treatment; researchers will collect data based on your existing condition or standard treatment.
This trial targets 3,350 participants in total. It began in 2024-02-01 with a primary completion date of 2026-07-31.
⚠ This information is for research awareness only. Always consult your physician before joining any clinical trial. Participation is voluntary and you may withdraw at any time.
Brief 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.
Eligibility Criteria
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.
Contact & Investigator
Frequently Asked Questions
Who can join the NCT06384846 clinical trial?
This trial is open to participants of all sexes, aged 18 Years or older, studying Acute Coronary Syndrome. Full inclusion and exclusion criteria are listed in the Eligibility Criteria section. Always confirm your eligibility with the research team before applying.
Is NCT06384846 currently recruiting?
Yes, NCT06384846 is actively recruiting participants. Contact the research team at shulkin@robotdreams.co for enrollment information.
Where is the NCT06384846 trial being conducted?
This trial is being conducted at Graz, Austria.
Who is sponsoring the NCT06384846 clinical trial?
NCT06384846 is sponsored by RobotDreams GmbH. The trial plans to enroll 3,350 participants.