Magnetic Resonance Technique in the Assessment of Exercise-induced Long- and Short-Term Changes in Cardiac Function and Morphology

Tracking Information
First Submitted Date	February 11, 2011
First Posted Date	February 28, 2011
Last Update Posted Date	May 15, 2013
Study Start Date	January 2011
Actual Primary Completion Date	May 2012 (Final data collection date for primary outcome measure)
Current Primary Outcome Measures; (submitted: February 25, 2011)	cardiac fibrosis (area in cm^2) on late contrast enhanced MR images [ Time Frame: at subject enrollment (cross-sectional design) ]
Original Primary Outcome Measures	Same as current
Change History	Complete list of historical versions of study NCT01305304 on ClinicalTrials.gov Archive Site
Current Secondary Outcome Measures; (submitted: March 7, 2011)	systolic/diastolic function and contractility measured by echocardiography [ Time Frame: 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) ]; anthropometric data [ Time Frame: at subject enrollment (cross-sectional design) ]; VO2max [ Time Frame: at subject enrollment (cross-sectional design) ]; resting-ECG [ Time Frame: at subject enrollment (cross-sectional design) ]; stress-ECG [ Time Frame: at subject enrollment (cross-sectional design) ]; blood analyses [ Time Frame: at subject enrollment (cross-sectional design) ]
Original Secondary Outcome Measures; (submitted: February 25, 2011)	systolic/diastolic function and contractility measured by echocardiography [ Time Frame: 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) ]; anthropometric data, VO2max, resting-ECG, stress-ECG, blood analyses [ Time Frame: at subject enrollment (cross-sectional design) ]
Current Other Outcome Measures	Not Provided
Original Other Outcome Measures	Not Provided
Descriptive Information
Brief Title	Magnetic Resonance Technique in the Assessment of Exercise-induced Long- and Short-Term Changes in Cardiac Function and Morphology
Official Title	Magnetic Resonance Technique in the Assessment of Exercise-induced Long- and Short-Term Changes in Cardiac Function and Morphology
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 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.
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	Observational
Study Design	Observational Model: Case Control; Time Perspective: Cross-Sectional
Target Follow-Up Duration	Not Provided
Biospecimen	Retention: Samples Without DNA; Description: serum, plasma
Sampling Method	Non-Probability Sample
Study Population	residents of Switzerland, either with history of national competitive endurance running (cases) or without history of endurance running (controls)
Condition	Myocardial Ischemia; Myocardial Infarction; Ventricular Remodeling; Myocardial Contraction; Ventricular Hypertrophy
Intervention	Other: repeated long term endurance exercise 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); Other: Other No history of endurance sports activity
Study Groups/Cohorts	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 Intervention: Other: repeated long term endurance exercise; 2 15 healthy male volunteers, matched for age and bmi, without a history of competitive physical exercise (i.e. sedentary controls) Intervention: Other: Other
Publications *	Not Provided
* Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
Recruitment Information
Recruitment Status	Completed
Actual Enrollment; (submitted: February 25, 2011)	30
Original Estimated Enrollment	Same as current
Actual Study Completion Date	July 2012
Actual Primary Completion Date	May 2012 (Final data collection date for primary outcome measure)
Eligibility Criteria	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)
Sex/Gender	Sexes Eligible for Study: Male
Ages	40 Years to 65 Years (Adult)
Accepts Healthy Volunteers	No
Contacts	Contact information is only displayed when the study is recruiting subjects
Listed Location Countries	Switzerland
Removed Location Countries
Administrative Information
NCT Number	NCT01305304
Other Study ID Numbers	KEK 005/010 B
Has Data Monitoring Committee	No
U.S. FDA-regulated Product	Not Provided
IPD Sharing Statement	Not Provided
Responsible Party	Dr.phil.nat. Dr.sci.med. Michael Ith, Dept. of Diagnostic, Interventional and Pediatric Radiology (DIPR) University & Inselspital Bern
Study Sponsor	University Hospital Inselspital, Berne
Collaborators	Federal Office of Sports, Switzerland
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
PRS Account	University Hospital Inselspital, Berne
Verification Date	May 2013