Biochemical and Electrocardiographic Signatures in the Detection of Exercise-induced Myocardial Ischemia
Trial statusRecruiting
Trial phaseNot listed
Trial typeObservational
Biological sexAll
Age18+
SponsorUniversity Hospital, Basel, Switzerland
About this trial
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.
Eligibility criteria
This trial does not accept healthy volunteersQualifiers
Patients presenting with suspected exercise-induced myocardial ischemia referred for rest/ergometry myocardial perfusion SPECT
Disqualifiers
Age < 18 years
Pregnancy
Unable or unwilling to give informed consent
Symptoms at rest or minor exertion
Trial population
Consecutive patients presenting with suspected exercise-induced myocardial ischemia referred for rest/ergometry myocardial perfusion SPECT.
Trial design
Design model
Other
Time perspective
Prospective
Treatments tested in this trial
Not listed
Trial groups
No trial groups listed
Trial outcomes
Primary outcomes
1
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
baselineSecondary outcomes
1
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 days2
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 years3
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 years4
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 yearsSponsors and contacts
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Source ClinicalTrials.gov