Myocardial IschemiaNCT01305304
Magnetic Resonance Technique in the Assessment of Exercise-induced Long- and Short-Term Changes in Cardiac Function and Morphology
An observational study of Myocardial Ischemia and Myocardial Infarction, run by Insel Gruppe AG, University Hospital Bern at 1 site in Switzerland.
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. Read more about this study
- Who is it for?
- Ages 40 to 65 years, men only
- Conditions the study is for
- Myocardial Ischemia, Myocardial Infarction, Ventricular Remodeling
- What is being tested?
- repeated long term endurance exercise and Other
- How many people
- 30 participants
- Where
- 1 siteSwitzerland
- Study dates
- Jan 2011to Jul 2012
- Phase
- Observational
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 40 to 65 years
- Men only
- No healthy volunteers
- Adult, Older adult
Study population: residents of Switzerland, either with history of national competitive endurance running (cases) or without history of endurance running (controls)
Who may be able to join
- Age 40-65y
- Healthy
- history of national competitive endurance running (cases)
- no history of endurance running (controls)
Who cannot join
- 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)
Trial locations and contacts
1 site in 1 country.
Switzerland1 site
Dept. of Diagnostic, Interventional and Pediatric Radiology, University Hospital Bern
Bern, CH-3010
About this study
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.
Read the 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.
- Conditions
- Myocardial Ischemia, Myocardial Infarction, Ventricular Remodeling, Myocardial Contraction, Ventricular Hypertrophy
- Being tested
- repeated long term endurance exercise, Other
- Medical subject headings
- Myocardial Ischemia, Myocardial Infarction, Ventricular Remodeling
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
repeated long term endurance exerciseOther
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)
OtherOther
No history of endurance sports activity
| Study group | Role | What they receive |
|---|---|---|
| 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 Receives: 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) Receives: Other: Other |
What is being measured
The primary outcome is the main question the study is designed to answer.
cardiac fibrosis (area in cm^2) on late contrast enhanced MR images
Measured: at subject enrollment (cross-sectional design)
Secondary outcomes (7)
systolic/diastolic function and contractility measured by echocardiography
Measured: at subject enrollment (cross-sectional design)
various parameters of cardiac function and morphology assessed with MRI and echocardiography
Measured: at subject enrollment (cross-sectional design)
anthropometric data
Measured: at subject enrollment (cross-sectional design)
VO2max
Measured: at subject enrollment (cross-sectional design)
resting-ECG
Measured: at subject enrollment (cross-sectional design)
stress-ECG
Measured: at subject enrollment (cross-sectional design)
blood analyses
Measured: at subject enrollment (cross-sectional design)
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted28 Feb 2011 (estimated)
- Study startJan 2011
- Primary completionMay 2012
- Study completionJul 2012
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Myocardial IschemiaStudies of the same condition, open and under way.
- More trials run by Insel Gruppe AG, University Hospital BernThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Case-control
- Time perspective
- Cross-sectional
- Enrolment
- 30 participants (actual)
Sponsor and investigators
- Lead sponsor
- Insel Gruppe AG, University Hospital Bern
- Sponsor type
- University, hospital or other
- Collaborators
- Federal Office of Sports, Switzerland
- Investigators
- Michael Ith, PhD, PhD/MD, Principal investigator, Dept. of Diagnostic, Interventional and Pediatric Radiology, University Hospital BernChristoph Stettler, MD, Principal investigator, Division of Endocrinology, Diabetes and Clinical Nutrition, University Hospital Bern
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01305304
- Sponsor's protocol ID
- KEK 005/010 B
- Status last verified
- May 2013
- First submitted
- 11 Feb 2011
- Last updated
- 15 May 2013
- Results posted
- No
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 15 May 2013. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Magnetic Resonance Technique in the Assessment of Exercise-induced Long- and Short-Term Changes in Cardiac Function and Morphology
- ClinicalTrials.gov ID
- NCT01305304
- Acronym / sponsor ID
- KEK 005/010 B
- Conditions
- Myocardial Ischemia, Myocardial Infarction, Ventricular Remodeling, Myocardial Contraction, Ventricular Hypertrophy
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 30 participants (actual)
- Lead sponsor
- Insel Gruppe AG, University Hospital BernUniversity, hospital or other
- Collaborators
- Federal Office of Sports, Switzerland
- Study start
- Jan 2011
- Primary completion
- May 2012 (actual)
- Study completion
- Jul 2012 (actual)
- First posted
- 28 Feb 2011 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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 design
- Observational model
- Case-control
- Time perspective
- Cross-sectional
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| 1 | – | Other: repeated long term endurance exercise15 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 |
| 2 | – | Other: Other15 healthy male volunteers, matched for age and bmi, without a history of competitive physical exercise (i.e. sedentary controls) |
Who may qualify
- Ages
- 40 to 65 years
- Sex
- Male only
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- residents of Switzerland, either with history of national competitive endurance running (cases) or without history of endurance running (controls)
Key inclusion criteria (4 listed)
- Age 40-65y
- Healthy
- history of national competitive endurance running (cases)
- no history of endurance running (controls)
Key exclusion criteria (8 listed)
- Contraindication for MRI
- History of relevant cardiac disease (including cardiomyopathies)
- coronary heart disease
- coronary abnormalities
- cardiovascular risk factors
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| repeated long term endurance exercisecompetitive 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 | 1 |
| OtherNo history of endurance sports activity | Other | 2 |
Primary outcome
cardiac fibrosis (area in cm^2) on late contrast enhanced MR images
Time frame: at subject enrollment (cross-sectional design)
7 secondary outcomes
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)
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 15 May 2013.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Michael Ith, PhD, PhD/MD principal investigator
Dept. of Diagnostic, Interventional and Pediatric Radiology, University Hospital Bern
Christoph Stettler, MD principal investigator
Division of Endocrinology, Diabetes and Clinical Nutrition, University Hospital Bern
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Myocardial Ischemia and Myocardial Infarction, run by Insel Gruppe AG, University Hospital Bern at 1 site in Switzerland.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 4 inclusion and 8 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 15 May 2013. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Switzerland. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
cardiac fibrosis (area in cm^2) on late contrast enhanced MR images (time frame: at subject enrollment (cross-sectional design)). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 15 May 2013.