- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT01179802
Exercise-induced Changes in Cardiac Function & Morphology
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 we 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 an intense endurance exercise, i.e. the "Jungfrau-Marathon", and which changes can possibly be found. Due to repeated measurements we will obtain further information on the short-term course of possible changes.
Hypotheses: A single bout of prolonged strenuous exercise (PSE) leads to transient alteration in cardiac function accompanied by the appearance of biomarkers for myocardial damage.
Study Overview
Status
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 quantify cardiac dysfunction after a single competitive PSE event and to study post-exercise changes in morphology and function as well as the post-exercise dynamics of specific markers of myocardial damage.
Methods
Cardiac and delayed contrast enhancement magnetic resonance imaging will be used in combination with echocardiographic methods to repetitively investigate post-exercise cardiac function and morphology in 10 elite athletes finishing the "Jungfrau Marathon". Biomarkers of myocardial damage are assessed simultaneously.
Post-exercise dynamics of the outcome parameters are followed over a minimum of 7 days after the exercise.
Study Type
Enrollment (Actual)
Phase
- Not Applicable
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
Description
Inclusion Criteria:
- Participants of the Jungfraumarathon 2010
- Elite runners defined by their results in the Jungfraumarathon 2009 (not more than 4:30 h, corresponding to a delay of 90 minutes compared to the winner)
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
Study Plan
How is the study designed?
Design Details
- Primary Purpose: Basic Science
- Allocation: N/A
- Interventional Model: Single Group Assignment
- Masking: None (Open Label)
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
---|---|
Experimental: 1
single event of a prolonged strenuous endurance exercise (mountain marathon)
|
"Jungfraumarathon": Mountain-Marathon with a length of 42km and a altitude-difference of approximately 1830meters.
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Time Frame |
---|---|
Quantification of edema and/or ischemic areas with MRI
Time Frame: baseline
|
baseline
|
Quantification of edema and/or ischemic areas with MRI
Time Frame: 24h post-marathon
|
24h post-marathon
|
Quantification of edema and/or ischemic areas with MRI
Time Frame: 5 days post-marathon
|
5 days post-marathon
|
Quantification of edema and/or ischemic areas with MRI
Time Frame: 8 days post-marathon
|
8 days post-marathon
|
Secondary Outcome Measures
Outcome Measure |
Time Frame |
---|---|
anthropometric data, VO2max, resting-ECG, stress-ECG, blood analyses
Time Frame: at baseline
|
at baseline
|
Cardiac contractility by echocardiography
Time Frame: 1h post-marathon
|
1h post-marathon
|
Cardiac contractility by echocardiography
Time Frame: 5 days post-marathon
|
5 days post-marathon
|
Cardiac contractility by echocardiography
Time Frame: 8 days post-marathon
|
8 days post-marathon
|
Cardiac contractility by echocardiography
Time Frame: baseline
|
baseline
|
various parameters of cardiac function and morphology assessed with MRI and echocardiography
Time Frame: baseline
|
baseline
|
various parameters of cardiac function and morphology assessed with MRI and echocardiography
Time Frame: 1h post-marathon
|
1h post-marathon
|
various parameters of cardiac function and morphology assessed with MRI and echocardiography
Time Frame: 1 day post-marathon
|
1 day post-marathon
|
various parameters of cardiac function and morphology assessed with MRI and echocardiography
Time Frame: 5 days post-marathon
|
5 days post-marathon
|
various parameters of cardiac function and morphology assessed with MRI and echocardiography
Time Frame: 8 days post-marathon
|
8 days post-marathon
|
Post-exercise levels and dynamics of blood parameters indicating cardiac damage, cardiac overload , inflammation and hormonal stress response
Time Frame: baseline
|
baseline
|
Post-exercise levels and dynamics of blood parameters indicating cardiac damage, cardiac overload , inflammation and hormonal stress response
Time Frame: 1h post-marathon
|
1h post-marathon
|
Post-exercise levels and dynamics of blood parameters indicating cardiac damage, cardiac overload , inflammation and hormonal stress response
Time Frame: 1 day post-marathon
|
1 day post-marathon
|
Post-exercise levels and dynamics of blood parameters indicating cardiac damage, cardiac overload , inflammation and hormonal stress response
Time Frame: 5 days post-marathon
|
5 days post-marathon
|
Post-exercise levels and dynamics of blood parameters indicating cardiac damage, cardiac overload , inflammation and hormonal stress response
Time Frame: 8 days post-marathon
|
8 days post-marathon
|
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
Publications and helpful links
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 005/10
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 Ischemia
-
Recardio, Inc.CompletedAcute Myocardial Infarction | STEMI - ST Elevation Myocardial Infarction | Acute Myocardial IschemiaNetherlands, Hungary, Austria, Poland, Belgium
-
University of Roma La SapienzaCompletedRosuvastatin in Preventing Myonecrosis in Elective Percutaneous Coronary Interventions (PCIs) (ROMA)Periprocedural Myocardial NecrosisItaly
-
Tomsk National Research Medical Center of the Russian...CompletedMyocardial Infarction | Myocardial Injury | STEMI | Myocardial NecrosisRussian Federation
-
Lokien van NunenMaquet Cardiovascular; Stichting Toegepaste Wetenschappen (project number 11052)CompletedAcute Myocardial Infarction | Persisting Ischemia | No ReflowNetherlands
-
University Hospital "Sestre Milosrdnice"CompletedSTEMI - ST Elevation Myocardial Infarction | Myocardial ReperfusionCroatia
-
Fundacio Privada Mon Clinic BarcelonaMiracor Medical SANot yet recruiting
-
Deutsches Herzzentrum MuenchenCompletedInfarction, MyocardialGermany
-
University Hospital, ToulouseThoratec CorporationWithdrawnChronic Myocardial IschemiaFrance
-
Barts & The London NHS TrustUniversity College, London; Queen Mary University of LondonCompletedAcute Myocardial InfarctionSwitzerland, Denmark, United Kingdom
-
Gennaro SardellaCompletedAssess the Periprocedural Myocardial NecrosisItaly
Clinical Trials on Strenuous Endurance exercise
-
University of CincinnatiCompletedStroke, Ischemic | Dysphagia, Oral PhaseUnited States
-
Riphah International UniversityCompleted
-
Norwegian University of Science and TechnologyLHL-Klinikkene, Røros; LHL-Klinikkene, FeiringWithdrawnVentricular Dysfunction, Left | Heart Failure, DiastolicNorway
-
University of TorontoCompleted
-
University of Illinois at Urbana-ChampaignNational Heart, Lung, and Blood Institute (NHLBI)CompletedVascular Health | Autonomic FunctionUnited States
-
Rigshospitalet, DenmarkCompleted
-
Charite University, Berlin, GermanyUnknown
-
University of LisbonFundação para a Ciência e a TecnologiaActive, not recruiting
-
University of CincinnatiEunice Kennedy Shriver National Institute of Child Health and Human Development... and other collaboratorsRecruitingIschemic Stroke | Dysphagia | Dysphagia, OropharyngealUnited States
-
Comenius UniversityUniversity of Roma La Sapienza; University of Primorska; University of Padova; Physiko-...Recruiting