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

This study is currently recruiting participants.
See Contacts and Locations
Verified September 2016 by Christian Müller, MD, University Hospital, Basel, Switzerland
Sponsor:
Information provided by (Responsible Party):
Christian Müller, MD, University Hospital, Basel, Switzerland
ClinicalTrials.gov Identifier:
NCT01838148
First received: April 12, 2013
Last updated: September 12, 2016
Last verified: September 2016
  Purpose
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.

Condition
Coronary Artery Disease Angina, Stable Exercise Test Biological Markers SPECT

Study Type: Observational
Study Design: Time Perspective: Prospective
Official Title: BASEL VIII Trial - Biochemical and Electrocardiographic Signatures in the Detection of Exercise-induced Myocardial Ischemia

Resource links provided by NLM:


Further study details as provided by Christian Müller, MD, University Hospital, Basel, Switzerland:

Primary Outcome Measures:
  • Diagnostic utility of novel biochemical and electrocardiographic signatures [ Time Frame: baseline ]
    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.


Secondary Outcome Measures:
  • One year event-free survival [ Time Frame: 360 days ]
    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

  • Five year event-free survival [ Time Frame: 5 years ]
    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

  • Eight year event-free survival [ Time Frame: 8 years ]
    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


Biospecimen Retention:   Samples Without DNA
EDTA, plasma

Estimated Enrollment: 4000
Study Start Date: May 2004
Estimated Study Completion Date: April 2017
Estimated Primary Completion Date: April 2017 (Final data collection date for primary outcome measure)
Detailed 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 4000 consecutive patients with suspected exercise induced myocardial ischemia referred for rest/ergometry myocardial perfusion SPECT. SPECT findings (complemented by coronary angiography 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 360 days and 5 years to record death, cardiovascular death, and acute myocardial infarction.

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.

  Eligibility

Ages Eligible for Study:   18 Years and older   (Adult, Senior)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Sampling Method:   Non-Probability Sample
Study Population
Consecutive patients presenting with suspected exercise-induced myocardial ischemia referred for rest/ergometry myocardial perfusion SPECT.
Criteria

Inclusion Criteria:

  • Patients presenting with suspected exercise-induced myocardial ischemia referred for rest/ergometry myocardial perfusion SPECT

Exclusion Criteria:

  • Age < 18 years
  • Pregnancy
  • Unable or unwilling to give informed consent
  • Symptoms at rest or minor exertion
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT01838148

Contacts
Contact: Christian Mueller, Prof. Dr. med. + 41 61328 65 49 Christian.Mueller@usb.ch

Locations
Switzerland
University Hospital Basel Recruiting
Basel, Switzerland, 4031
Contact: Christian Mueller, Prof. Dr. med.         
Principal Investigator: Christian Mueller, Prof. Dr. med.         
Sub-Investigator: Tobias Reichlin, MD         
Sub-Investigator: Michael Freese, UP         
Sub-Investigator: Raphael Twerenbold, MD         
Sub-Investigator: Michael Zellweger, Prof.         
Sub-Investigator: Max Wagener, MD         
Sponsors and Collaborators
University Hospital, Basel, Switzerland
Investigators
Principal Investigator: Christian Mueller, Prof. Dr. med. University Hospital, Basel, Switzerland
  More Information

Publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):
Responsible Party: Christian Müller, MD, Prof. Dr. med., University Hospital, Basel, Switzerland
ClinicalTrials.gov Identifier: NCT01838148     History of Changes
Other Study ID Numbers: BASEL VIII
Study First Received: April 12, 2013
Last Updated: September 12, 2016

Keywords provided by Christian Müller, MD, University Hospital, Basel, Switzerland:
coronary artery disease
angina, stable
exercise test
biological Markers
SPECT

Additional relevant MeSH terms:
Coronary Artery Disease
Myocardial Ischemia
Coronary Disease
Ischemia
Angina, Stable
Heart Diseases
Cardiovascular Diseases
Arteriosclerosis
Arterial Occlusive Diseases
Vascular Diseases
Pathologic Processes
Angina Pectoris
Chest Pain
Pain
Neurologic Manifestations
Nervous System Diseases
Signs and Symptoms

ClinicalTrials.gov processed this record on June 28, 2017