Actively Recruiting

Age: 18Years +
All Genders
ID01838148

BASEL VIII Trial - Biochemical and Electrocardiographic Signatures in the Detection of Exercise-induced Myocardial Ischemia

Led by University Hospital, Basel, Switzerland · Updated on 2025-07-11

4000

Participants Needed

1

Research Sites

N/A

Total Duration

On this page

AI-Summary

What this Trial Is About

Researchers are conducting a large observational study to evaluate new biochemical and electrocardiographic markers, both alone and combined with the standard 12-lead exercise ECG, to detect exercise-induced myocardial ischemia, which is linked to coronary artery disease (CAD). The study also aims to assess these markers' ability to predict the risk of cardiovascular death and heart attacks over long-term follow-up. This approach is important since current imaging techniques for CAD detection involve risks, are costly, and mainly provide anatomical rather than functional information. The study involves enrolling about 4200 patients suspected of having exercise-induced myocardial ischemia who are referred for rest or exercise myocardial perfusion SPECT testing. Before the exercise stress test, venous blood samples will be collected to measure various biochemical markers possibly related to ischemia, such as cardiac troponins, B-type natriuretic peptide, IL-6, and cardiac microRNA. Additionally, continuous ECG recordings will be obtained before, during, and after exercise using advanced devices and processing methods to identify new electronic markers. All tests will be analyzed without knowledge of patient clinical data to ensure unbiased results. Participants will undergo the exercise stress testing and blood sampling at baseline. Follow-up will be conducted at 1, 2, 5, and 8 years to record clinical outcomes including death, cardiovascular death, heart attacks, and coronary revascularization. The research team will evaluate the diagnostic usefulness of the new biochemical and ECG signatures at baseline and monitor long-term event-free survival. This comprehensive approach aims to improve non-invasive detection and risk assessment for patients with suspected CAD, potentially simplifying current testing and reducing exposure to radiation and contrast agents.

CONDITIONS

Brief Title

Biochemical and Electrocardiographic Signatures in the Detection of Exercise-induced Myocardial Ischemia

Who Can Participate

Age: 18Years +
All Genders

Eligibility Criteria

Eligible

You may qualify if you...

  • Patients presenting with suspected exercise-induced myocardial ischemia referred for rest/ergometry myocardial perfusion SPECT
  • Adults aged 18 years and older
Not Eligible

You will not qualify if you...

  • Age under 18 years
  • Pregnancy
  • Unable or unwilling to give informed consent
  • Symptoms at rest or minor exertion

AI-Screening

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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 - 1 day

Participants undergo exercise stress testing with biochemical blood sampling and continuous ECG recording to evaluate for exercise-induced myocardial ischemia.

1 visit (in-person)

Long-term Monitoring

Duration - Up to 8 years

Participants are followed up to record cardiovascular events including death, cardiovascular death, acute myocardial infarction, and coronary revascularization.

Follow-up assessments at 1 year, 2 years, 5 years, and 8 years

Trial Site Locations

Total: 1 location

1

University Hospital Basel

Basel, Switzerland, 4031

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Research Team

C

Christian Mueller, Prof. Dr. MD

How is the study designed?

Study Type

OBSERVATIONAL

Masking

N/A

Allocation

N/A

Model

N/A

Primary Purpose

N/A

Number of Arms

0

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Published Research Related To This Trial

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Melissa Amrein, Xinmin S Li, Joan Walter...

https://pubmed.ncbi.nlm.nih.gov/35220448

Soluble urokinase plasminogen activator receptor and functionally relevant coronary artery disease: a prospective cohort study.

Joan Elias Walter, Melissa Lee Fen Amrein, Ibrahim Schäfer...

https://pubmed.ncbi.nlm.nih.gov/35112976

Using High-Sensitivity Cardiac Troponin for the Exclusion of Inducible Myocardial Ischemia in Symptomatic Patients: A Cohort Study.

Joan Walter, Jeanne du Fay de Lavallaz, Luca Koechlin...

https://pubmed.ncbi.nlm.nih.gov/31905377

Automatically computed ECG algorithm for the quantification of myocardial scar and the prediction of mortality.

Patrick Badertscher, Ivo Strebel, Ursina Honegger...

https://pubmed.ncbi.nlm.nih.gov/29667014

Combining high-sensitivity cardiac troponin and B-type natriuretic peptide in the detection of inducible myocardial ischemia.

Christian Puelacher, Max Wagener, Ursina Honegger...

https://pubmed.ncbi.nlm.nih.gov/29107010

Direct comparison of cardiac troponin I and cardiac troponin T in the detection of exercise-induced myocardial ischemia.

Seoung Mann Sou, Christian Puelacher, Raphael Twerenbold...

https://pubmed.ncbi.nlm.nih.gov/26708172