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

This study has been terminated.
Sponsor:
Information provided by (Responsible Party):
Oliver Strohm, University of Calgary
ClinicalTrials.gov Identifier:
NCT00739895
First received: August 20, 2008
Last updated: October 2, 2011
Last verified: October 2011
  Purpose

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.


Condition Intervention
Ventricular Function, Left
Procedure: Cardiac magnetic Resonance study
Procedure: Blood testing

Study Type: Observational
Study Design: Observational Model: Case Control
Time Perspective: Prospective
Official Title: Left Ventricular Dilatation in Athletes With Common Colds; a Cardio-vascular MRI Study

Resource links provided by NLM:


Further study details as provided by University of Calgary:

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 ]

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

Estimated Enrollment: 100
Study Start Date: June 2007
Study Completion Date: September 2011
Primary Completion Date: September 2011 (Final data collection date for primary outcome measure)
Groups/Cohorts Assigned Interventions
Athletes
high performing athletes
Procedure: Cardiac magnetic Resonance study
follow-up studies
Procedure: Blood testing
Blood sample tested for myocardial biomarkers

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.

  Eligibility

Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   Yes
Sampling Method:   Non-Probability Sample
Study Population

high performance athletes, during acute viremia and at variable training intensities. Healthy individuals from the general public will serve as a reference group.

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
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT00739895

Locations
Canada, Alberta
Stephenson CMR Centre at Foothills Medical Centre, University of Calgary
Calgary, Alberta, Canada, T2N 2T9
Sponsors and Collaborators
University of Calgary
Investigators
Principal Investigator: Matthias G Friedrich, MD, FESC University of Calgary
  More Information

No publications provided

Responsible Party: Oliver Strohm, adunct Research Associate Professor, University of Calgary
ClinicalTrials.gov Identifier: NCT00739895     History of Changes
Other Study ID Numbers: Athletes_001
Study First Received: August 20, 2008
Last Updated: October 2, 2011
Health Authority: Canada: Health Canada

Keywords provided by University of Calgary:
athletes

Additional relevant MeSH terms:
Common Cold
Picornaviridae Infections
RNA Virus Infections
Virus Diseases
Respiratory Tract Infections
Respiratory Tract Diseases

ClinicalTrials.gov processed this record on August 01, 2014