- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT00739895
Assessment of Cardiac Involvement of Common Cold in High Performing Athletes by Cardiac Magnetic Resonance Imaging (MRI)
Left Ventricular Dilatation in Athletes With Common Colds; a Cardio-vascular MRI Study
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.
Athletes 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.
Study Overview
Status
Conditions
Intervention / Treatment
Detailed Description
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.
Athletes 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.
Image 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.
Study Type
Enrollment (Anticipated)
Contacts and Locations
Study Locations
-
-
Alberta
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Calgary, Alberta, Canada, T2N 2T9
- Stephenson CMR Centre at Foothills Medical Centre, University of Calgary
-
-
Participation Criteria
Eligibility Criteria
Ages Eligible for Study
- Child
- Adult
- Older Adult
Accepts Healthy Volunteers
Genders Eligible for Study
Sampling Method
Study Population
Description
Inclusion Criteria:
- Informed consent;
- feverish feeling with last 72 hours;
- active participation in competitive sports;
- history of recent viral exposure or flu-like symptoms.
Exclusion Criteria:
- CMR Contraindications,
- chronic diseases affecting the heart,
- use of immuno-active drugs
Study Plan
How is the study designed?
Design Details
Cohorts and Interventions
Group / Cohort |
Intervention / Treatment |
|---|---|
|
Athletes
high performing athletes
|
follow-up studies
Blood sample tested for myocardial biomarkers
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Time Frame |
|---|---|
|
Left-ventricular systolic dysfunction, as defined by increased left ventricular end-diastolic volume
Time Frame: 12 months
|
12 months
|
Secondary Outcome Measures
Outcome Measure |
Time Frame |
|---|---|
|
Myocardial edema, fibrosis, inflammation, volumetry
Time Frame: 12 months
|
12 months
|
Collaborators and Investigators
Sponsor
Investigators
- Principal Investigator: Matthias G Friedrich, MD, FESC, University of Calgary
Study record dates
Study Major Dates
Study Start
Primary Completion (Actual)
Study Completion (Actual)
Study Registration Dates
First Submitted
First Submitted That Met QC Criteria
First Posted (Estimate)
Study Record Updates
Last Update Posted (Estimate)
Last Update Submitted That Met QC Criteria
Last Verified
More Information
Terms related to this study
Keywords
Additional Relevant MeSH Terms
Other Study ID Numbers
- Athletes_001
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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