Clinical Trial Details
— Status: Recruiting
Administrative data
| NCT number |
NCT01838148 |
| Other study ID # |
BASEL VIII |
| Secondary ID |
|
| Status |
Recruiting |
| Phase |
|
| First received |
|
| Last updated |
|
| Start date |
May 2004 |
| Est. completion date |
December 2024 |
Study information
| Verified date |
September 2021 |
| Source |
University Hospital, Basel, Switzerland |
| Contact |
Christian Mueller, Prof. Dr. MD |
| Phone |
+ 41 61328 65 49 |
| Email |
Christian.Mueller[@]usb.ch |
| Is FDA regulated |
No |
| Health authority |
|
| Study type |
Observational
|
Clinical Trial Summary
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.
Description:
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.
