Diagnostic Performance of Artificial Intelligence Algorithms in Prediction of Acute Coronary Syndrome Based on White Blood Cell Properties (AI-ACS Trial)
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.
• 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.