Exercise-induced Changes in Cardiac Function & Morphology
Primary Purpose
Myocardial Ischemia, Exercise, Myocardial Contraction
Status
Completed
Phase
Not Applicable
Locations
Switzerland
Study Type
Interventional
Intervention
Strenuous Endurance exercise
Sponsored by
About this trial
This is an interventional basic science trial for Myocardial Ischemia
Eligibility Criteria
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
Sites / Locations
- Dept. of Diagnostic, Interventional and Pediatric Radiology, University Hospital Bern
Arms of the Study
Arm 1
Arm Type
Experimental
Arm Label
1
Arm Description
single event of a prolonged strenuous endurance exercise (mountain marathon)
Outcomes
Primary Outcome Measures
Quantification of edema and/or ischemic areas with MRI
Quantification of edema and/or ischemic areas with MRI
Quantification of edema and/or ischemic areas with MRI
Quantification of edema and/or ischemic areas with MRI
Secondary Outcome Measures
anthropometric data, VO2max, resting-ECG, stress-ECG, blood analyses
Cardiac contractility by echocardiography
Cardiac contractility by echocardiography
Cardiac contractility by echocardiography
Cardiac contractility by echocardiography
various parameters of cardiac function and morphology assessed with MRI and echocardiography
various parameters of cardiac function and morphology assessed with MRI and echocardiography
various parameters of cardiac function and morphology assessed with MRI and echocardiography
various parameters of cardiac function and morphology assessed with MRI and echocardiography
various parameters of cardiac function and morphology assessed with MRI and echocardiography
Post-exercise levels and dynamics of blood parameters indicating cardiac damage, cardiac overload , inflammation and hormonal stress response
Post-exercise levels and dynamics of blood parameters indicating cardiac damage, cardiac overload , inflammation and hormonal stress response
Post-exercise levels and dynamics of blood parameters indicating cardiac damage, cardiac overload , inflammation and hormonal stress response
Post-exercise levels and dynamics of blood parameters indicating cardiac damage, cardiac overload , inflammation and hormonal stress response
Post-exercise levels and dynamics of blood parameters indicating cardiac damage, cardiac overload , inflammation and hormonal stress response
Full Information
NCT ID
NCT01179802
First Posted
August 10, 2010
Last Updated
February 14, 2011
Sponsor
Insel Gruppe AG, University Hospital Bern
Collaborators
Federal Office of Sports, Switzerland
1. Study Identification
Unique Protocol Identification Number
NCT01179802
Brief Title
Exercise-induced Changes in Cardiac Function & Morphology
Official Title
Magnetic Resonance Technique in the Assessment of Exercise-induced Long- and Short-Term Changes in Cardiac Function and Morphology
Study Type
Interventional
2. Study Status
Record Verification Date
February 2011
Overall Recruitment Status
Completed
Study Start Date
July 2010 (undefined)
Primary Completion Date
October 2010 (Actual)
Study Completion Date
October 2010 (Actual)
3. Sponsor/Collaborators
Name of the Sponsor
Insel Gruppe AG, University Hospital Bern
Collaborators
Federal Office of Sports, Switzerland
4. Oversight
Data Monitoring Committee
No
5. Study Description
Brief Summary
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.
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.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Myocardial Ischemia, Exercise, Myocardial Contraction, Myocardial Stunning, Heart Failure
7. Study Design
Primary Purpose
Basic Science
Study Phase
Not Applicable
Interventional Study Model
Single Group Assignment
Masking
None (Open Label)
Allocation
N/A
Enrollment
11 (Actual)
8. Arms, Groups, and Interventions
Arm Title
1
Arm Type
Experimental
Arm Description
single event of a prolonged strenuous endurance exercise (mountain marathon)
Intervention Type
Other
Intervention Name(s)
Strenuous Endurance exercise
Intervention Description
"Jungfraumarathon": Mountain-Marathon with a length of 42km and a altitude-difference of approximately 1830meters.
Primary Outcome Measure Information:
Title
Quantification of edema and/or ischemic areas with MRI
Time Frame
baseline
Title
Quantification of edema and/or ischemic areas with MRI
Time Frame
24h post-marathon
Title
Quantification of edema and/or ischemic areas with MRI
Time Frame
5 days post-marathon
Title
Quantification of edema and/or ischemic areas with MRI
Time Frame
8 days post-marathon
Secondary Outcome Measure Information:
Title
anthropometric data, VO2max, resting-ECG, stress-ECG, blood analyses
Time Frame
at baseline
Title
Cardiac contractility by echocardiography
Time Frame
1h post-marathon
Title
Cardiac contractility by echocardiography
Time Frame
5 days post-marathon
Title
Cardiac contractility by echocardiography
Time Frame
8 days post-marathon
Title
Cardiac contractility by echocardiography
Time Frame
baseline
Title
various parameters of cardiac function and morphology assessed with MRI and echocardiography
Time Frame
baseline
Title
various parameters of cardiac function and morphology assessed with MRI and echocardiography
Time Frame
1h post-marathon
Title
various parameters of cardiac function and morphology assessed with MRI and echocardiography
Time Frame
1 day post-marathon
Title
various parameters of cardiac function and morphology assessed with MRI and echocardiography
Time Frame
5 days post-marathon
Title
various parameters of cardiac function and morphology assessed with MRI and echocardiography
Time Frame
8 days post-marathon
Title
Post-exercise levels and dynamics of blood parameters indicating cardiac damage, cardiac overload , inflammation and hormonal stress response
Time Frame
baseline
Title
Post-exercise levels and dynamics of blood parameters indicating cardiac damage, cardiac overload , inflammation and hormonal stress response
Time Frame
1h post-marathon
Title
Post-exercise levels and dynamics of blood parameters indicating cardiac damage, cardiac overload , inflammation and hormonal stress response
Time Frame
1 day post-marathon
Title
Post-exercise levels and dynamics of blood parameters indicating cardiac damage, cardiac overload , inflammation and hormonal stress response
Time Frame
5 days post-marathon
Title
Post-exercise levels and dynamics of blood parameters indicating cardiac damage, cardiac overload , inflammation and hormonal stress response
Time Frame
8 days post-marathon
10. Eligibility
Sex
Male
Minimum Age & Unit of Time
20 Years
Maximum Age & Unit of Time
40 Years
Accepts Healthy Volunteers
Accepts Healthy Volunteers
Eligibility Criteria
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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Michael Ith, PhD, PhD/MD
Organizational Affiliation
Dept. of Diagnostic, Interventional and Pediatric Radiology, University Hospital Bern
Official's Role
Principal Investigator
First Name & Middle Initial & Last Name & Degree
Christoph Stettler, MD
Organizational Affiliation
Division of Endocrinology, Diabetes and Clinical Nutrition, University Hospital Bern
Official's Role
Principal Investigator
Facility Information:
Facility Name
Dept. of Diagnostic, Interventional and Pediatric Radiology, University Hospital Bern
City
Bern
ZIP/Postal Code
CH-3010
Country
Switzerland
12. IPD Sharing Statement
Citations:
PubMed Identifier
23253265
Citation
Wilhelm M, Zueger T, De Marchi S, Rimoldi SF, Brugger N, Steiner R, Stettler C, Nuoffer JM, Seiler C, Ith M. Inflammation and atrial remodeling after a mountain marathon. Scand J Med Sci Sports. 2014 Jun;24(3):519-25. doi: 10.1111/sms.12030. Epub 2012 Dec 18.
Results Reference
derived
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Exercise-induced Changes in Cardiac Function & Morphology
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