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

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

Enrollment (Actual)

30

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

      • Bern, Switzerland, CH-3010
        • Dept. of Diagnostic, Interventional and Pediatric Radiology, University Hospital Bern

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

40 years to 65 years (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

Male

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)

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

This section provides details of the study plan, including how the study is designed and what the study is measuring.

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

This is where you will find people and organizations involved with this study.

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

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

January 1, 2011

Primary Completion (Actual)

May 1, 2012

Study Completion (Actual)

July 1, 2012

Study Registration Dates

First Submitted

February 11, 2011

First Submitted That Met QC Criteria

February 25, 2011

First Posted (Estimate)

February 28, 2011

Study Record Updates

Last Update Posted (Estimate)

May 15, 2013

Last Update Submitted That Met QC Criteria

May 14, 2013

Last Verified

May 1, 2013

More Information

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.

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