NCT00739895

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.

Trial Health

57
Monitor

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
100

participants targeted

Target at P50-P75 for all trials

Timeline
Completed

Started Jun 2007

Longer than P75 for all trials

Geographic Reach
1 country

1 active site

Status
terminated

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

June 1, 2007

Completed
1.2 years until next milestone

First Submitted

Initial submission to the registry

August 20, 2008

Completed
2 days until next milestone

First Posted

Study publicly available on registry

August 22, 2008

Completed
3 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

September 1, 2011

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

September 1, 2011

Completed
Last Updated

October 4, 2011

Status Verified

October 1, 2011

Enrollment Period

4.3 years

First QC Date

August 20, 2008

Last Update Submit

October 2, 2011

Conditions

Keywords

athletes

Outcome Measures

Primary Outcomes (1)

  • Left-ventricular systolic dysfunction, as defined by increased left ventricular end-diastolic volume

    12 months

Secondary Outcomes (1)

  • Myocardial edema, fibrosis, inflammation, volumetry

    12 months

Study Arms (1)

Athletes

high performing athletes

Procedure: Cardiac magnetic Resonance studyProcedure: Blood testing

Interventions

follow-up studies

Athletes
Blood testingPROCEDURE

Blood sample tested for myocardial biomarkers

Athletes

Eligibility Criteria

Sexall
Healthy VolunteersYes
Age GroupsChild (0-17), Adult (18-64), Older Adult (65+)
Sampling MethodNon-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.

You may qualify if:

  • Informed consent;
  • feverish feeling with last 72 hours;
  • active participation in competitive sports;
  • history of recent viral exposure or flu-like symptoms.

You may not qualify if:

  • CMR Contraindications,
  • chronic diseases affecting the heart,
  • use of immuno-active drugs

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Stephenson CMR Centre at Foothills Medical Centre, University of Calgary

Calgary, Alberta, T2N 2T9, Canada

Location

MeSH Terms

Interventions

Hematologic Tests

Intervention Hierarchy (Ancestors)

Clinical Laboratory TechniquesDiagnostic Techniques and ProceduresDiagnosisInvestigative Techniques

Study Officials

  • Matthias G Friedrich, MD, FESC

    University of Calgary

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
observational
Observational Model
CASE CONTROL
Time Perspective
PROSPECTIVE
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
adunct Research Associate Professor

Study Record Dates

First Submitted

August 20, 2008

First Posted

August 22, 2008

Study Start

June 1, 2007

Primary Completion

September 1, 2011

Study Completion

September 1, 2011

Last Updated

October 4, 2011

Record last verified: 2011-10

Locations