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

This study has been completed.
Sponsor:
Collaborator:
Federal Office of Sports, Switzerland
Information provided by:
University Hospital Inselspital, Berne
ClinicalTrials.gov Identifier:
NCT01305304
First received: February 11, 2011
Last updated: May 14, 2013
Last verified: May 2013
  Purpose

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.


Condition Intervention
Myocardial Ischemia
Myocardial Infarction
Ventricular Remodeling
Myocardial Contraction
Ventricular Hypertrophy
Other: repeated long term endurance exercise
Other: Other

Study Type: Observational
Study Design: Observational Model: Case Control
Time Perspective: Cross-Sectional
Official Title: Magnetic Resonance Technique in the Assessment of Exercise-induced Long- and Short-Term Changes in Cardiac Function and Morphology

Resource links provided by NLM:


Further study details as provided by University Hospital Inselspital, Berne:

Primary Outcome Measures:
  • cardiac fibrosis (area in cm^2) on late contrast enhanced MR images [ Time Frame: at subject enrollment (cross-sectional design) ] [ Designated as safety issue: No ]

Secondary Outcome Measures:
  • systolic/diastolic function and contractility measured by echocardiography [ Time Frame: at subject enrollment (cross-sectional design) ] [ Designated as safety issue: No ]
  • various parameters of cardiac function and morphology assessed with MRI and echocardiography [ Time Frame: at subject enrollment (cross-sectional design) ] [ Designated as safety issue: No ]
  • anthropometric data [ Time Frame: at subject enrollment (cross-sectional design) ] [ Designated as safety issue: No ]
  • VO2max [ Time Frame: at subject enrollment (cross-sectional design) ] [ Designated as safety issue: No ]
  • resting-ECG [ Time Frame: at subject enrollment (cross-sectional design) ] [ Designated as safety issue: No ]
  • stress-ECG [ Time Frame: at subject enrollment (cross-sectional design) ] [ Designated as safety issue: No ]
  • blood analyses [ Time Frame: at subject enrollment (cross-sectional design) ] [ Designated as safety issue: No ]

Biospecimen Retention:   Samples Without DNA

serum, plasma


Enrollment: 30
Study Start Date: January 2011
Study Completion Date: July 2012
Primary Completion Date: May 2012 (Final data collection date for primary outcome measure)
Groups/Cohorts Assigned Interventions
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
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)
2
15 healthy male volunteers, matched for age and bmi, without a history of competitive physical exercise (i.e. sedentary controls)
Other: Other
No history of endurance sports activity

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.

  Eligibility

Ages Eligible for Study:   40 Years to 65 Years
Genders Eligible for Study:   Male
Accepts Healthy Volunteers:   No
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)

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)
  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: NCT01305304

Locations
Switzerland
Dept. of Diagnostic, Interventional and Pediatric Radiology, University Hospital Bern
Bern, Switzerland, CH-3010
Sponsors and Collaborators
University Hospital Inselspital, Berne
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
  More Information

No publications provided

Responsible Party: Dr.phil.nat. Dr.sci.med. Michael Ith, Dept. of Diagnostic, Interventional and Pediatric Radiology (DIPR) University & Inselspital Bern
ClinicalTrials.gov Identifier: NCT01305304     History of Changes
Other Study ID Numbers: KEK 005/010 B
Study First Received: February 11, 2011
Last Updated: May 14, 2013
Health Authority: Switzerland: Ethikkommission

Additional relevant MeSH terms:
Myocardial Ischemia
Coronary Artery Disease
Hypertrophy
Infarction
Ischemia
Myocardial Infarction
Ventricular Remodeling
Heart Diseases
Cardiovascular Diseases
Vascular Diseases
Coronary Disease
Arteriosclerosis
Arterial Occlusive Diseases
Pathological Conditions, Anatomical
Pathologic Processes
Necrosis

ClinicalTrials.gov processed this record on July 29, 2014