Assessment of Cardiac Involvement of Common Cold in High Performing Athletes by Cardiac Magnetic Resonance Imaging (MRI)

Ventricular Function, Left Clinical Trial

Official title:

Left Ventricular Dilatation in Athletes With Common Colds; a Cardio-vascular MRI Study

Clinical Trial Details — Status: Terminated

Administrative data

• NCT number: NCT00739895
• Other study ID #: Athletes_001
• Status: Terminated
• Phase: N/A
• First received: August 20, 2008
• Last updated: October 2, 2011
• Start date: June 2007
• Est. completion date: September 2011

Study information

• Verified date: October 2011
• Source: University of Calgary
• Contact: n/a
• Is FDA regulated: No
• Health authority: Canada: Health Canada
• Study type: Observational

Clinical Trial Summary

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.

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.

Recruitment information / eligibility

• Status: Terminated
• Enrollment: 100
• Est. completion date: September 2011
• Est. primary completion date: September 2011
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: Both
• Age group: N/A and older

Eligibility

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 Design

Observational Model: Case Control, Time Perspective: Prospective

Related Conditions & MeSH terms

• Common Cold
• Ventricular Function, Left

Intervention

Procedure:
• Cardiac magnetic Resonance study
follow-up studies
• Blood testing
Blood sample tested for myocardial biomarkers

Locations

Country	Name	City	State
Canada	Stephenson CMR Centre at Foothills Medical Centre, University of Calgary	Calgary	Alberta

Sponsors (1)

Lead Sponsor	Collaborator
University of Calgary

Country where clinical trial is conducted

Canada, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Left-ventricular systolic dysfunction, as defined by increased left ventricular end-diastolic volume		12 months	No
Secondary	Myocardial edema, fibrosis, inflammation, volumetry		12 months	No