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

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Tracking Information

First Received Date ^†

August 20, 2008

Last Updated Date

August 21, 2008

Start Date ^†

June 2007

Current Primary Outcome Measures ^†

Left-ventricular systolic dysfunction, as defined by increased left ventricular end-diastolic volume [ Time Frame: 12 months ] [ Designated as safety issue: No ]

Original Primary Outcome Measures ^†

Same as current

Change History

Complete list of historical versions of study NCT00739895 on ClinicalTrials.gov Archive Site

Current Secondary Outcome Measures ^†

Myocardial edema, fibrosis, inflammation, volumetry [ Time Frame: 12 months ] [ Designated as safety issue: No ]

Original Secondary Outcome Measures ^†

Same as current

Descriptive Information

Brief Title ^†

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

Official Title ^†

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

Brief 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.

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.

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 Phase

Study Type ^†

Observational

Study Design ^†

Case Control, Prospective

Condition ^†

Ventricular Function, Left

Intervention ^†

Procedure: Cardiac magnetic Resonance study
Procedure: Blood testing

Study Arms / Comparison Groups

high performing athletes

Publications *

* Includes publications given by the data provider as well as publications identified by National Clinical Trials Identifier (NCT ID) in Medline.

Recruitment Information

Recruitment Status ^†

Enrolling by invitation

Enrollment ^†

100

Estimated Completion Date

June 2009

Estimated Primary Completion Date

November 2008 (final data collection date for primary outcome measure)

Eligibility Criteria ^†

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

Gender

Both

Ages

Accepts Healthy Volunteers

Yes

Contacts ^††

Location Countries ^†

Canada

Expanded Access Status

Administrative Information

NCT ID ^†

NCT00739895

Responsible Party

University of Calgary, University of Calgary

Secondary IDs ^††

Study Sponsor ^†

University of Calgary

Collaborators ^††

Investigators ^†

Principal Investigator:

Matthias G Friedrich, MD, FESC

University of Calgary

Information Provided By

University of Calgary

Verification Date

August 2008

^† Required WHO trial registration data element.
^†† WHO trial registration data element that is required only if it exists.