Ignite Creation Date:
2025-12-24 @ 9:10 PM
Ignite Modification Date:
2025-12-30 @ 9:36 PM
Study NCT ID:
NCT01305304
Status:
COMPLETED
Last Update Posted:
2013-05-15
First Post:
2011-02-11
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Magnetic Resonance Technique in the Assessment of Exercise-induced Long- and Short-Term Changes in Cardiac Function and Morphology
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D017202', 'term': 'Myocardial Ischemia'}, {'id': 'D009203', 'term': 'Myocardial Infarction'}, {'id': 'D020257', 'term': 'Ventricular Remodeling'}], 'ancestors': [{'id': 'D006331', 'term': 'Heart Diseases'}, {'id': 'D002318', 'term': 'Cardiovascular Diseases'}, {'id': 'D014652', 'term': 'Vascular Diseases'}, {'id': 'D007238', 'term': 'Infarction'}, {'id': 'D007511', 'term': 'Ischemia'}, {'id': 'D010335', 'term': 'Pathologic Processes'}, {'id': 'D013568', 'term': 'Pathological Conditions, Signs and Symptoms'}, {'id': 'D009336', 'term': 'Necrosis'}, {'id': 'D020763', 'term': 'Pathological Conditions, Anatomical'}]}}, 'protocolSection': {'designModule': {'bioSpec': {'retention': 'SAMPLES_WITHOUT_DNA', 'description': 'serum, plasma'}, 'studyType': 'OBSERVATIONAL', 'designInfo': {'timePerspective': 'CROSS_SECTIONAL', 'observationalModel': 'CASE_CONTROL'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 30}}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2011-01'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2013-05', 'completionDateStruct': {'date': '2012-07', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2013-05-14', 'studyFirstSubmitDate': '2011-02-11', 'studyFirstSubmitQcDate': '2011-02-25', 'lastUpdatePostDateStruct': {'date': '2013-05-15', 'type': 'ESTIMATED'}, 'studyFirstPostDateStruct': {'date': '2011-02-28', 'type': 'ESTIMATED'}, 'primaryCompletionDateStruct': {'date': '2012-05', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'cardiac fibrosis (area in cm^2) on late contrast enhanced MR images', 'timeFrame': 'at subject enrollment (cross-sectional design)'}], 'secondaryOutcomes': [{'measure': 'systolic/diastolic function and contractility measured by echocardiography', 'timeFrame': 'at subject enrollment (cross-sectional design)'}, {'measure': 'various parameters of cardiac function and morphology assessed with MRI and echocardiography', 'timeFrame': 'at subject enrollment (cross-sectional design)'}, {'measure': 'anthropometric data', 'timeFrame': 'at subject enrollment (cross-sectional design)'}, {'measure': 'VO2max', 'timeFrame': 'at subject enrollment (cross-sectional design)'}, {'measure': 'resting-ECG', 'timeFrame': 'at subject enrollment (cross-sectional design)'}, {'measure': 'stress-ECG', 'timeFrame': 'at subject enrollment (cross-sectional design)'}, {'measure': 'blood analyses', 'timeFrame': 'at subject enrollment (cross-sectional design)'}]}, 'oversightModule': {'oversightHasDmc': False}, 'conditionsModule': {'conditions': ['Myocardial Ischemia', 'Myocardial Infarction', 'Ventricular Remodeling', 'Myocardial Contraction', 'Ventricular Hypertrophy']}, 'descriptionModule': {'briefSummary': "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.\n\nWithin 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.", 'detailedDescription': 'Background\n\nDespite 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.\n\nObjective\n\nTo 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.\n\nMethods\n\nCardiac 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.'}, 'eligibilityModule': {'sex': 'MALE', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'maximumAge': '65 Years', 'minimumAge': '40 Years', 'samplingMethod': 'NON_PROBABILITY_SAMPLE', 'studyPopulation': 'residents of Switzerland, either with history of national competitive endurance running (cases) or without history of endurance running (controls)', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* Age 40-65y\n* Healthy\n* history of national competitive endurance running (cases)\n* no history of endurance running (controls)\n\nExclusion Criteria\n\n* Contraindication for MRI\n* History of relevant cardiac disease (including cardiomyopathies)\n* coronary heart disease\n* coronary abnormalities\n* cardiovascular risk factors\n* History of any chronic disease\n* drug abuse\n* Arrhythmias which make adequate echocardiography unfeasible (such as atrial fibrillation or bundle-branch blocks)'}, 'identificationModule': {'nctId': 'NCT01305304', 'briefTitle': 'Magnetic Resonance Technique in the Assessment of Exercise-induced Long- and Short-Term Changes in Cardiac Function and Morphology', 'organization': {'class': 'OTHER', 'fullName': 'Insel Gruppe AG, University Hospital Bern'}, 'officialTitle': 'Magnetic Resonance Technique in the Assessment of Exercise-induced Long- and Short-Term Changes in Cardiac Function and Morphology', 'orgStudyIdInfo': {'id': 'KEK 005/010 B'}}, 'armsInterventionsModule': {'armGroups': [{'label': '1', 'description': '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', 'interventionNames': ['Other: repeated long term endurance exercise']}, {'label': '2', 'description': '15 healthy male volunteers, matched for age and bmi, without a history of competitive physical exercise (i.e. sedentary controls)', 'interventionNames': ['Other: Other']}], 'interventions': [{'name': 'repeated long term endurance exercise', 'type': 'OTHER', 'description': '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)', 'armGroupLabels': ['1']}, {'name': 'Other', 'type': 'OTHER', 'description': 'No history of endurance sports activity', 'armGroupLabels': ['2']}]}, 'contactsLocationsModule': {'locations': [{'zip': 'CH-3010', 'city': 'Bern', 'country': 'Switzerland', 'facility': 'Dept. of Diagnostic, Interventional and Pediatric Radiology, University Hospital Bern', 'geoPoint': {'lat': 46.94809, 'lon': 7.44744}}], 'overallOfficials': [{'name': 'Michael Ith, PhD, PhD/MD', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'Dept. of Diagnostic, Interventional and Pediatric Radiology, University Hospital Bern'}, {'name': 'Christoph Stettler, MD', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'Division of Endocrinology, Diabetes and Clinical Nutrition, University Hospital Bern'}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Insel Gruppe AG, University Hospital Bern', 'class': 'OTHER'}, 'collaborators': [{'name': 'Federal Office of Sports, Switzerland', 'class': 'OTHER_GOV'}], 'responsibleParty': {'oldNameTitle': 'Dr.phil.nat. Dr.sci.med. Michael Ith', 'oldOrganization': 'Dept. of Diagnostic, Interventional and Pediatric Radiology (DIPR) University & Inselspital Bern'}}}}