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

Status: Recruiting
Location: See location...
Study Type: Observational
SUMMARY

The goal of this observational study is to find out if artificial intelligence (AI) can accurately predict acute coronary syndrome (ACS) using data on white blood cells in adults. The main question it aims to answer is: \- Can AI algorithms based on white blood cell data predict ACS with accuracy comparable to that of high-sensitivity cardiac troponin (hs-cTn)? Researchers will look at how the AI model's predictions stack up against the standard hs-cTn blood tests to see which is more accurate in diagnosing ACS. Participants in this study will have already had blood tests as part of their usual care. Their previously collected health information and blood test results will be used to help train and test the AI algorithms. Participants will not undergo any new procedures for the study itself.

Eligibility
Participation Requirements
Sex: All
Minimum Age: 18
Healthy Volunteers: t
View:

• Male or Female, aged 18 years or above

• Participant is willing and able to give informed consent for participation in the study

• Subjects presenting without chest pain or with stable angina pectoris but without 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 need to be fulfilled (see 5.14)

• o Subjects with no or stable angina pectoris must have provided WBC data and at least one hs-cTn value any time before start of coronary angiography.

• Between initial blood sampling to collect WBC data and coronary angiography, the subject must not develop suspicion of ACS.

Locations
Other Locations
Austria
Landeskrankenhaus-Universitätsklinikum Graz
RECRUITING
Graz
Contact Information
Primary
Dimitrij Shulkin, M.Sc.
shulkin@robotdreams.co
+43-676-5150578
Backup
Johannes Gollmer, Dr. univ.
johannes.gollmer@medunigraz.at
Time Frame
Start Date: 2024-02-01
Estimated Completion Date: 2026-12-31
Participants
Target number of participants: 2700
Treatments
Control-Cohort
Subjects with suspected ACS but exclusion of a culprit lesion during coronary angiography.
Case-Cohort
Subjects with suspected ACS and identification of a culprit lesion during coronary angiography.
Supplementary cohort
Subjects with no or stable angina pectoris and no indication for revascularization during coronary angiography.
Sponsors
Leads: RobotDreams GmbH

This content was sourced from clinicaltrials.gov