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

Myocardial Infarction Clinical Trial

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT01305304
• Other study ID #: KEK 005/010 B
• Status: Completed
• Phase: N/A
• First received: February 11, 2011
• Last updated: May 14, 2013
• Start date: January 2011
• Est. completion date: July 2012

Study information

• Verified date: May 2013
• Source: University Hospital Inselspital, Berne
• Contact: n/a
• Is FDA regulated: No
• Health authority: Switzerland: Ethikkommission
• Study type: Observational

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 30
• Est. completion date: July 2012
• Est. primary completion date: May 2012
• Accepts healthy volunteers: No
• Gender: Male
• Age group: 40 Years to 65 Years

Eligibility

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 Design

Observational Model: Case Control, Time Perspective: Cross-Sectional

Related Conditions & MeSH terms

• Coronary Artery Disease
• Hypertrophy
• Myocardial Contraction
• Myocardial Infarction
• Myocardial Ischemia
• Ventricular Hypertrophy
• Ventricular Remodeling

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
No history of endurance sports activity

Locations

Country	Name	City	State
Switzerland	Dept. of Diagnostic, Interventional and Pediatric Radiology, University Hospital Bern	Bern

Sponsors (2)

Lead Sponsor	Collaborator
University Hospital Inselspital, Berne	Federal Office of Sports, Switzerland

Country where clinical trial is conducted

Switzerland, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	cardiac fibrosis (area in cm^2) on late contrast enhanced MR images		at subject enrollment (cross-sectional design)	No
Secondary	systolic/diastolic function and contractility measured by echocardiography		at subject enrollment (cross-sectional design)	No
Secondary	various parameters of cardiac function and morphology assessed with MRI and echocardiography		at subject enrollment (cross-sectional design)	No
Secondary	anthropometric data		at subject enrollment (cross-sectional design)	No
Secondary	VO2max		at subject enrollment (cross-sectional design)	No
Secondary	resting-ECG		at subject enrollment (cross-sectional design)	No
Secondary	stress-ECG		at subject enrollment (cross-sectional design)	No
Secondary	blood analyses		at subject enrollment (cross-sectional design)	No