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

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.

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