Ignite Creation Date:
2025-12-24 @ 2:06 PM
Ignite Modification Date:
2026-01-02 @ 11:53 PM
Study NCT ID:
NCT00739895
Status:
TERMINATED
Last Update Posted:
2011-10-04
First Post:
2008-08-20
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Assessment of Cardiac Involvement of Common Cold in High Performing Athletes by Cardiac Magnetic Resonance Imaging (MRI)
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'interventionBrowseModule': {'meshes': [{'id': 'D006403', 'term': 'Hematologic Tests'}], 'ancestors': [{'id': 'D019411', 'term': 'Clinical Laboratory Techniques'}, {'id': 'D019937', 'term': 'Diagnostic Techniques and Procedures'}, {'id': 'D003933', 'term': 'Diagnosis'}, {'id': 'D008919', 'term': 'Investigative Techniques'}]}}, 'protocolSection': {'designModule': {'studyType': 'OBSERVATIONAL', 'designInfo': {'timePerspective': 'PROSPECTIVE', 'observationalModel': 'CASE_CONTROL'}, 'enrollmentInfo': {'type': 'ESTIMATED', 'count': 100}}, 'statusModule': {'overallStatus': 'TERMINATED', 'startDateStruct': {'date': '2007-06'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2011-10', 'completionDateStruct': {'date': '2011-09', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2011-10-02', 'studyFirstSubmitDate': '2008-08-20', 'studyFirstSubmitQcDate': '2008-08-21', 'lastUpdatePostDateStruct': {'date': '2011-10-04', 'type': 'ESTIMATED'}, 'studyFirstPostDateStruct': {'date': '2008-08-22', 'type': 'ESTIMATED'}, 'primaryCompletionDateStruct': {'date': '2011-09', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Left-ventricular systolic dysfunction, as defined by increased left ventricular end-diastolic volume', 'timeFrame': '12 months'}], 'secondaryOutcomes': [{'measure': 'Myocardial edema, fibrosis, inflammation, volumetry', 'timeFrame': '12 months'}]}, 'oversightModule': {'oversightHasDmc': True}, 'conditionsModule': {'keywords': ['athletes'], 'conditions': ['Ventricular Function, Left']}, 'descriptionModule': {'briefSummary': 'Cardiovascular magnetic resonance (CMR) imaging will be used to assess the impact of common colds and physical training in high-performing athletes. Healthy individuals from the general public will serve as a comparison group. CMR has previously been shown to accurately assess cardiac function, edema, inflammation, and injury.\n\nAthletes competing at National level and Developmental Canadian teams will be prospectively recruited. All participants will have CMR scans at low and high intensity training. Participants will be re-scanned immediately after clinical evidence of a common cold, as determined by respiratory and flu-like symptoms. After 4 weeks, a follow-up CMR scan will be performed. On the day of each CMR scan, electrocardiograms and blood samples will be drawn from each participant. Blood samples will provide markers of systemic inflammation, such as leukocyte counts. At each CMR scan, athletes will be asked to describe there recent history of physical exertion in questionnaires, which will reflect the degree of physical exertion performed.', 'detailedDescription': 'Cardiovascular magnetic resonance (CMR) imaging will be used to assess the impact of a common colds and physical training in high-performing athletes. Healthy individuals from the general public will serve as a comparison group. CMR has previously been shown to accurately assess cardiac function, edema, inflammation, and injury.\n\nAthletes competing at National level and Developmental Canadian teams will be prospectively recruited. All participants will have CMR scans at low and high intensity training. Participants will be re-scanned immediately after clinical evidence of a common cold, as determined by respiratory and flu-like symptoms. After 4 weeks, a follow-up CMR scan will be performed. On the day of each CMR scan, electrocardiograms and blood samples will be drawn from each participant. Blood samples will provide markers of systemic inflammation, such as leukocyte counts. At each CMR scan, athletes will be asked to describe there recent history of physical exertion in questionnaires, which will reflect the degree of physical exertion performed.\n\nImage analysis: CMR parameters that serve as surrogate markers for myocardial inflammation will be assessed. Specifically, they include STIR (edema), early enhancement (inflammation), and late enhancement (fibrosis). The presence of 2 of these parameters will indicate the presence of myocardial inflammation. Qualitative and quantitative analysis will be performed on images obtained from CMR scans, and will be assessed offline using CMR42 (Circle International, Calgary) software. Standard methods of assessing edema, inflammation, and fibrosis will be implemented. Standard left ventricular function volume analysis techniques will be implemented to assess left ventricular dilatation.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['CHILD', 'ADULT', 'OLDER_ADULT'], 'samplingMethod': 'NON_PROBABILITY_SAMPLE', 'studyPopulation': 'high performance athletes, during acute viremia and at variable training intensities. Healthy individuals from the general public will serve as a reference group.', 'healthyVolunteers': True, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* Informed consent;\n* feverish feeling with last 72 hours;\n* active participation in competitive sports;\n* history of recent viral exposure or flu-like symptoms.\n\nExclusion Criteria:\n\n* CMR Contraindications,\n* chronic diseases affecting the heart,\n* use of immuno-active drugs'}, 'identificationModule': {'nctId': 'NCT00739895', 'briefTitle': 'Assessment of Cardiac Involvement of Common Cold in High Performing Athletes by Cardiac Magnetic Resonance Imaging (MRI)', 'organization': {'class': 'OTHER', 'fullName': 'University of Calgary'}, 'officialTitle': 'Left Ventricular Dilatation in Athletes With Common Colds; a Cardio-vascular MRI Study', 'orgStudyIdInfo': {'id': 'Athletes_001'}}, 'armsInterventionsModule': {'armGroups': [{'label': 'Athletes', 'description': 'high performing athletes', 'interventionNames': ['Procedure: Cardiac magnetic Resonance study', 'Procedure: Blood testing']}], 'interventions': [{'name': 'Cardiac magnetic Resonance study', 'type': 'PROCEDURE', 'description': 'follow-up studies', 'armGroupLabels': ['Athletes']}, {'name': 'Blood testing', 'type': 'PROCEDURE', 'description': 'Blood sample tested for myocardial biomarkers', 'armGroupLabels': ['Athletes']}]}, 'contactsLocationsModule': {'locations': [{'zip': 'T2N 2T9', 'city': 'Calgary', 'state': 'Alberta', 'country': 'Canada', 'facility': 'Stephenson CMR Centre at Foothills Medical Centre, University of Calgary', 'geoPoint': {'lat': 51.05011, 'lon': -114.08529}}], 'overallOfficials': [{'name': 'Matthias G Friedrich, MD, FESC', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'University of Calgary'}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'University of Calgary', 'class': 'OTHER'}, 'responsibleParty': {'type': 'PRINCIPAL_INVESTIGATOR', 'investigatorTitle': 'adunct Research Associate Professor', 'investigatorFullName': 'Oliver Strohm', 'investigatorAffiliation': 'University of Calgary'}}}}