- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT01305304
Magnetic Resonance Technique in the Assessment of Exercise-induced Long- and Short-Term Changes in Cardiac Function and Morphology
Until now it has been assumed that regular endurance training has a positive influence on cardiac function and that the positive effect increases with increasing intensity. However, little is known about the effects of intense endurance stress on the heart. According to current knowledge repeated exposure to strenuous endurance activity may lead to minor but possibly irreversible damage to the heart with resultant scarring of the heart's muscle.
Within this study the investigators attempt to find out by different analytical methods - in particular magnetic resonance imaging (MRI) and ultrasound of the heart - to what extent the heart muscle is affected by long term intense endurance exercise and which changes in cardiac function and morphology can possibly be found. Therefore the investigators compare former national competitive endurance athletes with sedentary controls.
Study Overview
Status
Conditions
Intervention / Treatment
Detailed Description
Background
Despite the well documented cardio-protective effects of aerobic exercise of moderate intensity, short- and long-term consequences of strenuous exercise are less clear. There is increasing evidence that maintaining a high cardiac workload over a prolonged duration may result in transient impairment of cardiac function. Recent studies have also reported a transient increase in cardiac biomarkers after prolonged strenuous exercise. While in patients with cardiac disease the presence of cardiac dysfunction and increased cardiac biomarkers generally reflects myocardial damage, the impact of these observations in athletes is ill defined. It is a matter of concern whether in athletes such findings simply reflect a reversible response or whether repetitive events may lead to an accumulative cardiac damage. Traditional echocardiographic methods used to determine potential cardiac changes in morphology or function are investigator-dependent and may be subject to interference by cardiac pre- and afterload. Cardiac magnetic resonance imaging provides an investigator-independent and objective method to quantify cardiac dimensions and function. Delayed contrast enhancement MR imaging is a highly reproducible cardiovascular magnetic resonance imaging technique to directly visualize myocardial edema, necrosis and fibrosis.
Objective
To use cardiac and delayed contrast enhancement magnetic resonance imaging in combination with echocardiographic methods to to assess whether athletes involved in prolonged strenuous exercise over years reveal persistent alterations of cardiac morphology and function.
Methods
Cardiac and delayed contrast enhancement magnetic resonance imaging will be used in combination with echocardiographic methods to investigate whether involvement in prolonged strenuous exercise over years leads to changes in cardiac function and morphology. Therefore we study and compare 15 veteran elite athletes and 15 sedentary controls. The use of cardiac MRI and delayed contrast enhancement magnetic resonance imaging techniques will be paralleled by echocardiographic and tissue Doppler measurements to allow comparative analyses of the two methods.
Study Type
Enrollment (Actual)
Contacts and Locations
Study Locations
-
-
-
Bern, Switzerland, CH-3010
- Dept. of Diagnostic, Interventional and Pediatric Radiology, University Hospital Bern
-
-
Participation Criteria
Eligibility Criteria
Ages Eligible for Study
Accepts Healthy Volunteers
Genders Eligible for Study
Sampling Method
Study Population
Description
Inclusion Criteria:
- Age 40-65y
- Healthy
- history of national competitive endurance running (cases)
- no history of endurance running (controls)
Exclusion Criteria
- Contraindication for MRI
- History of relevant cardiac disease (including cardiomyopathies)
- coronary heart disease
- coronary abnormalities
- cardiovascular risk factors
- History of any chronic disease
- drug abuse
- Arrhythmias which make adequate echocardiography unfeasible (such as atrial fibrillation or bundle-branch blocks)
Study Plan
How is the study designed?
Design Details
- Observational Models: Case-Control
- Time Perspectives: Cross-Sectional
Cohorts and Interventions
Group / Cohort |
Intervention / Treatment |
---|---|
1
15 healthy male "veteran" runners (marathon, triathlon, orienteering) aged between 40 and 65 years with a history of competitive running at a national level during a period of at least 5 years, implicating normally a runner career with at least 50km per week over more than 10 years
|
competitive running at a national level during a period of at least 5 years (i.e.
approximately 50km per week over more than 10 years)
|
2
15 healthy male volunteers, matched for age and bmi, without a history of competitive physical exercise (i.e.
sedentary controls)
|
No history of endurance sports activity
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Time Frame |
---|---|
cardiac fibrosis (area in cm^2) on late contrast enhanced MR images
Time Frame: at subject enrollment (cross-sectional design)
|
at subject enrollment (cross-sectional design)
|
Secondary Outcome Measures
Outcome Measure |
Time Frame |
---|---|
systolic/diastolic function and contractility measured by echocardiography
Time Frame: at subject enrollment (cross-sectional design)
|
at subject enrollment (cross-sectional design)
|
various parameters of cardiac function and morphology assessed with MRI and echocardiography
Time Frame: at subject enrollment (cross-sectional design)
|
at subject enrollment (cross-sectional design)
|
anthropometric data
Time Frame: at subject enrollment (cross-sectional design)
|
at subject enrollment (cross-sectional design)
|
VO2max
Time Frame: at subject enrollment (cross-sectional design)
|
at subject enrollment (cross-sectional design)
|
resting-ECG
Time Frame: at subject enrollment (cross-sectional design)
|
at subject enrollment (cross-sectional design)
|
stress-ECG
Time Frame: at subject enrollment (cross-sectional design)
|
at subject enrollment (cross-sectional design)
|
blood analyses
Time Frame: at subject enrollment (cross-sectional design)
|
at subject enrollment (cross-sectional design)
|
Collaborators and Investigators
Collaborators
Investigators
- Principal Investigator: Michael Ith, PhD, PhD/MD, Dept. of Diagnostic, Interventional and Pediatric Radiology, University Hospital Bern
- Principal Investigator: Christoph Stettler, MD, Division of Endocrinology, Diabetes and Clinical Nutrition, University Hospital Bern
Study record dates
Study Major Dates
Study Start
Primary Completion (Actual)
Study Completion (Actual)
Study Registration Dates
First Submitted
First Submitted That Met QC Criteria
First Posted (Estimate)
Study Record Updates
Last Update Posted (Estimate)
Last Update Submitted That Met QC Criteria
Last Verified
More Information
Terms related to this study
Additional Relevant MeSH Terms
Other Study ID Numbers
- KEK 005/010 B
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
Clinical Trials on Myocardial Infarction
-
Azienda ULSS 5 PolesanaUniversity of PadovaUnknownMyocardial Infarction, Acute | ST Segment Elevation Myocardial Infarction | Non-ST Elevation Myocardial Infarction (nSTEMI)Italy
-
University Medical Centre LjubljanaCompletedCardiac Arrest | Postresuscitation Syndrome | Myocardial Infarction (ST-Elevation Myocardial Infarction and Non-ST-Elevation Myocardial Infarction)Slovenia
-
Fundacio Privada Mon Clinic BarcelonaMiracor Medical SANot yet recruiting
-
Stiftung Institut fuer HerzinfarktforschungGlaxoSmithKline; University Hospital Muenster; Klinikum NürnbergCompletedMyocardial Infarction | ST-Elevation Myocardial Infarction | Non-ST-Elevation Myocardial InfarctionGermany
-
Bispebjerg HospitalOdense University Hospital; Zealand University Hospital; Hvidovre University... and other collaboratorsRecruitingST Elevation Myocardial Infarction | Acute Myocardial Infarction | Non-ST Elevation Myocardial Infarction (nSTEMI)Denmark
-
Population Health Research InstituteCanadian Institutes of Health Research (CIHR); Boston Scientific CorporationActive, not recruitingST Elevation Myocardial Infarction | Non ST Elevation Myocardial InfarctionCanada
-
University of LeedsUniversity College, LondonCompletedST-elevation Myocardial Infarction | Non ST-elevation Myocardial Infarction
-
Karolinska InstitutetUppsala University; The Swedish Research CouncilActive, not recruitingST Elevation Myocardial Infarction | Acute Myocardial Infarction | Non-ST Elevation Myocardial InfarctionSweden
-
Oslo University HospitalVestre Viken Hospital Trust; University of Oslo; University Hospital of North... and other collaboratorsActive, not recruitingST Elevation Myocardial Infarction | Acute Myocardial Infarction | Non-ST Elevation Myocardial InfarctionNorway
-
Barts & The London NHS TrustUniversity College, London; Queen Mary University of LondonCompletedAcute Myocardial InfarctionSwitzerland, Denmark, United Kingdom
Clinical Trials on repeated long term endurance exercise
-
Slovak Academy of SciencesMedical University of ViennaRecruiting
-
Leiden University Medical CenterDutch Health Care Insurance BoardUnknownRheumatoid Arthritis
-
Spine Centre of Southern DenmarkDepartment of Sports Science and Clinical Biomechanics, University of Southern...Completed
-
Aarhus University HospitalNational Hospital of the Faroe IslandsCompletedCoronary Artery Disease | Inflammation | Exercise | HemostasisFaroe Islands
-
Ukraine Association of BiobankActive, not recruitingDiabete Type 2 | Mesenchymal Stem CellUkraine
-
Helsinki University Central HospitalCompleted
-
Mental Health Services in the Capital Region, DenmarkUniversity of Copenhagen; Copenhagen Trial Unit, Center for Clinical Intervention...Completed
-
Sun Yat-sen UniversityUnknownMultifocal Contact LensesChina
-
Haukeland University HospitalOslo University Hospital; University Hospital of North Norway; Helse Stavanger... and other collaboratorsRecruitingNervous System Diseases | Neurodegenerative Diseases | Motor Neuron Disease | Amyotrophic Lateral Sclerosis | Spinal Cord Diseases | TDP-43 ProteinopathiesNorway
-
University of BernCompletedDental Implants | PeriimplantitisSwitzerland