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Age: 18Years +
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ID06384846

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

Led by RobotDreams GmbH · Updated on 2024-04-25

2700

Participants Needed

1

Research Sites

21 weeks

Total Duration

On this page

AI-Summary

What this Trial Is About

Researchers are evaluating the ability of artificial intelligence (AI) algorithms to predict acute coronary syndrome (ACS) using white blood cell data in adults. This observational study compares the accuracy of AI predictions with the standard high-sensitivity cardiac troponin (hs-cTn) blood tests to see which method better diagnoses ACS. The study aims to improve rapid identification of patients at risk by analyzing routine blood tests with AI technology. The study collects white blood cell data from routine blood tests performed at patient admission using specialized hematology analyzers. The AI models are trained and tested in two phases, each lasting up to 36 months, using data from patients with various chest pain conditions, including those with suspected ACS. No new procedures or treatments are administered as part of the study; it relies entirely on previously collected blood test results and patient information. Participants have already undergone blood testing as part of their usual care, and their existing health data is used to develop and validate AI models. The study includes continuous data quality checks, source data verification, and adherence to strict protocols to ensure accuracy. Researchers monitor how well the AI models perform compared to hs-cTn tests in diagnosing ACS. The total participation duration depends on the data collection timeline, with no extra visits or interventions required.

CONDITIONS

Brief Title

AI Algorithms in Prediction of ACS Based on Leukocyte Properties

Who Can Participate

Age: 18Years +
All Genders
Healthy Volunteers

Eligibility Criteria

Eligible

You may qualify if you...

  • Male or Female, aged 18 years or above
  • Willing and able to give informed consent for participation
  • Subjects presenting without chest pain or with stable angina pectoris but no indication for revascularization during coronary angiography
  • Exclusion of elevated high-sensitivity cardiac troponin (hs-cTn)
  • Timing criteria for blood sampling of white blood cell and hs-cTn data need to be met
  • Subjects with no or stable angina must have provided white blood cell data and at least one hs-cTn value before coronary angiography
  • No suspicion of acute coronary syndrome between initial blood sampling and coronary angiography
Not Eligible

You will not qualify if you...

  • Age under 18 years
  • Refusal to give informed consent
  • Inability to collect white blood cell and hs-cTn data
  • Inability to meet timing criteria for blood sampling
  • Suspicion of acute coronary syndrome in subjects with no or stable angina between initial blood sampling and coronary angiography

AI-Screening

AI-Powered Screening

Complete this quick 3-step screening to check your eligibility

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Your Study Journey

Screening

Duration - 2 to 4 weeks

Participants are screened for eligibility to participate in the trial.

1 visit (in-person)

Diagnostic Evaluation

Duration - Up to 36 months

Participants undergo routine blood tests measuring white blood cell properties and high-sensitivity cardiac troponin to collect data for AI model training and testing.

Blood tests performed at admission and as required during hospital visits

Long-term Monitoring

Duration - Up to 36 months

Participants' data are continuously monitored to validate and refine AI algorithms predicting acute coronary syndrome.

Periodic data collection through routine clinical care

Trial Site Locations

Total: 1 location

1

Landeskrankenhaus-Universitätsklinikum Graz

Graz, Styria / Steiermark, Austria, 8036

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Research Team

D

Dimitrij Shulkin, M.Sc.

J

Johannes Gollmer, Dr. univ.

How is the study designed?

Study Type

OBSERVATIONAL

Masking

N/A

Allocation

N/A

Model

N/A

Primary Purpose

N/A

Number of Arms

3

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