An observational study in Coronary Artery Disease, Angina, Stable and Exercise Test, sponsored by University Hospital, Basel, Switzerland. Recruiting at 1 site in Switzerland. Open to participants aged 18 Years and older. Per ClinicalTrials.gov, last updated 2025-07-11.
Sponsored by University Hospital, Basel, Switzerland · Observational
The primary aim is to perform the largest study worldwide to evaluate novel biochemical and electrocardiographic signatures alone as well as in combination with the standard 12-lead exercise ECG in the detection of exercise-induced myocardial ischemia (diagnostic endpoint). The secondary aim is to evaluate these innovative tools in the risk prediction for the occurrence of cardiovascular death and acute myocardial infarction during long-term follow-up.
Background: The detection of coronary artery disease (CAD) is one of the most important tasks in medicine. Exercise-induced myocardial ischemia is the pathophysiological hallmark of stable CAD. Currently, sophisticated imaging techniques including coronary angiography, rest/stress myocardial perfusion single-photon emission computed tomography (SPECT), and coronary CT-scanning are required to accurately detect CAD. Unfortunately, these techniques are associated with inherent risks due to substantial radiation exposure, intraarterial or intravenous application of iodinated contrast media, mechanical complications, require referral to a specialist, and are very costly. In addition, most of them provide anatomical but not functional information. For clinical practice, functional information that differentiates lesions that cause exercise-induced myocardial ischemia from functionally irrelevant lesions is critical. Exercise electrocardiography (ECG) is a widely used simple and non-invasive functional test, which however has imperfect sensitivity and specificity (both below 75%) in the detection of CAD. Novel cardiac biomarkers as well as novel computer-based quantitative approaches to analyse the ECG signal recorded during exercise offered by advances in information technology and signal processing may provide incremental value to the exercise ECG and thereby improve clinical care.
Aim: The primary aim is to perform the largest study worldwide to evaluate novel biochemical and electrocardiographic signatures alone as well as in combination with the standard 12-lead exercise ECG in the detection of exercise-induced myocardial ischemia (diagnostic endpoint). The secondary aim is to evaluate these innovative tools in the risk prediction for the occurrence of cardiovascular death and acute myocardial infarction during long-term follow-up.
Methodology: We will enroll approximately 4200 consecutive patients with suspected exercise induced myocardial ischemia referred for rest/ergometry myocardial perfusion SPECT. SPECT findings (complemented by coronary angiography and fractional flow reserve [FFR, if availabe] findings in patients who obtain both investigations) are used to adjudicate and quantify the presence of myocardial ischemia (the primary diagnostic end point). Clinical long-term follow-up will be obtained at 1 year, 2 years, 5 years and 8 years to record death, cardiovascular death, and acute myocardial infarction as well as coronary revascularisation.
Investigational tests: Venous blood samples will be collected before exercise stress testing for the determination of biochemical signatures possibly associated with myocardial ischemia including high-sensitivity cardiac troponin I, high-sensitivity cardiac troponin T, B-type natriuretic peptide, IL-6, and cardiac microRNA. In addition, continuous ECG signals are recorded using 12 leads (16 leads in a subset of patients) and 24-bit amplitude resolution with 8000 Hz sampling frequency before, during and after the stress test. Novel methods of computer-based ECG signal-processing technology will be used to decipher electronic markers of myocardial ischemia and to develop improved software algorithms for automated ECG interpretation. All investigational tests will be performed in a blinded fashion.
Potential Significance: We hypothesize that biochemical and electrocardiographic signals of myocardial ischemia will significantly improve the non-invasive detection of exercise-induced myocardial ischemia. This would markedly improve the initiation of treatment in affected patients and thus advance medical management of patients with suspected CAD. In addition, this approach would help to simplify (exercise ECG versus myocardial SPECT) the non-invasive detection of exercise-induced myocardial ischemia and help to avoid the inherent health hazards associated current radiologic imaging procedures.
4,857 studies on the registry are indexed under Coronary Artery Disease; 890 are open to participants now.
This study's planned enrollment of 4,000 is above the median of 320 across 1,687 observational studies indexed under Coronary Artery Disease.
Browse Coronary Artery Disease studies →University Hospital, Basel, Switzerland is the lead sponsor of 990 studies on the registry; 189 are open to participants now.
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Consecutive patients presenting with suspected exercise-induced myocardial ischemia referred for rest/ergometry myocardial perfusion SPECT.
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Exclusion Criteria:
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Before you join, the study team explains what taking part involves — its purpose, what happens, the risks and possible benefits — and answers your questions, so you can decide freely. Consent is usually recorded on a form (the informed consent form, ICF) signed by you or, where the law allows, by someone legally authorised to decide for you.
You can keep asking questions during the study, you are told of new information that matters, and you can choose to leave at any time.
Informed consent
Before you join, the study team explains what taking part involves — its purpose, what happens, the risks and possible benefits — and answers your questions, so you can decide freely. Consent is usually recorded on a form (the informed consent form, ICF) signed by you or, where the law allows, by someone legally authorised to decide for you.
You can keep asking questions during the study, you are told of new information that matters, and you can choose to leave at any time.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Diagnostic utility of novel biochemical and electrocardiographic signatures
Diagnostic utility of biochemical (i.e. cardiac troponin, brain natriuretic peptide) and electrocardiographic signatures alone as well as in combination with the standard 12-lead exercise ECG in the detection of exercise-induced myocardial ischemia, mainly quantified by the area under the receiver operating characteristics curves (AUC ROC) and positive/negative predictive values, respectively.
Time frame: baseline
One year event-free survival
Prognostic utility of biochemical (i.e. cardiac troponins, brain natriuretic peptides) and electrocardiographic signatures in the risk prediction for the occurrence of cardiovascular death and acute myocardial infarction
Time frame: 360 days
Two year event-free survival
Prognostic utility of biochemical (i.e. cardiac troponins, brain natriuretic peptides) and electrocardiographic signatures in the risk prediction for the occurrence of cardiovascular death and acute myocardial infarction
Time frame: 2 years
Five year event-free survival
Prognostic utility of biochemical (i.e. cardiac troponins, brain natriuretic peptides) and electrocardiographic signatures in the risk prediction for the occurrence of cardiovascular death and acute myocardial infarction
Time frame: 5 years
Eight year event-free survival
Prognostic utility of biochemical (i.e. cardiac troponins, brain natriuretic peptides) and electrocardiographic signatures in the risk prediction for the occurrence of cardiovascular death and acute myocardial infarction
Time frame: 8 years
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