Ventricular Function, LeftNCT00739895
Assessment of Cardiac Involvement of Common Cold in High Performing Athletes by Cardiac Magnetic Resonance Imaging (MRI)
An observational study of Ventricular Function, Left, run by University of Calgary at 1 site in Canada.
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. Read more about this study
- Who is it for?
- Any ageHealthy volunteers can take part
- Conditions the study is for
- Ventricular Function, Left
- What is being tested?
- Cardiac magnetic Resonance study and Blood testing
- Type of treatment
- Surgery or procedure
- How many people
- 100 participants
- Where
- 1 siteCanada
- Study dates
- Jun 2007to Sep 2011
- Phase
- Observational
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages Any age
- All sexes
- Healthy volunteers accepted
- Child, Adult, Older adult
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.
Who may be able to join
- Informed consent;
- feverish feeling with last 72 hours;
- active participation in competitive sports;
- history of recent viral exposure or flu-like symptoms.
Who cannot join
- CMR Contraindications,
- chronic diseases affecting the heart,
- use of immuno-active drugs
Trial locations and contacts
1 site in 1 country.
Canada1 site
Stephenson CMR Centre at Foothills Medical Centre, University of Calgary
Calgary, Alberta, T2N 2T9
About this study
Official title: 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.
Read the 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.
- Conditions
- Ventricular Function, Left
- Being tested
- Cardiac magnetic Resonance study, Blood testing
- Keywords
- athletes
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Cardiac magnetic Resonance studyProcedure or surgery
follow-up studies
Blood testingProcedure or surgery
Blood sample tested for myocardial biomarkers
| Study group | Role | What they receive |
|---|---|---|
| Athletes | high performing athletes Receives: Procedure: Cardiac magnetic Resonance study; Procedure: Blood testing |
What is being measured
The primary outcome is the main question the study is designed to answer.
Left-ventricular systolic dysfunction, as defined by increased left ventricular end-diastolic volume
Measured: 12 months
Secondary outcomes (1)
Myocardial edema, fibrosis, inflammation, volumetry
Measured: 12 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted22 Aug 2008 (estimated)
- Study startJun 2007
- Primary completionSep 2011
- Study completionSep 2011
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Ventricular Function, LeftStudies of the same condition, open and under way.
- More trials run by University of CalgaryThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Case-control
- Time perspective
- Prospective
- Enrolment
- 100 participants (estimated)
Sponsor and investigators
- Lead sponsor
- University of Calgary
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Oliver Strohm, University of Calgary
- Investigators
- Matthias G Friedrich, MD, FESC, Principal investigator, University of Calgary
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00739895
- Sponsor's protocol ID
- Athletes_001
- Status last verified
- Oct 2011
- First submitted
- 20 Aug 2008
- Last updated
- 4 Oct 2011
- Results posted
- No
- Data monitoring committee
- Yes
Study at a glance
From the registry record, last updated by the sponsor on 4 Oct 2011. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Left Ventricular Dilatation in Athletes With Common Colds; a Cardio-vascular MRI Study
- ClinicalTrials.gov ID
- NCT00739895
- Acronym / sponsor ID
- Athletes_001
- Conditions
- Ventricular Function, Left
- Keywords
- athletes
- Study type
- Observational
- Recruitment status
- Terminated
- Enrolment
- 100 participants (estimated)
- Lead sponsor
- University of CalgaryUniversity, hospital or other
- Study start
- Jun 2007
- Primary completion
- Sep 2011 (actual)
- Study completion
- Sep 2011 (actual)
- First posted
- 22 Aug 2008 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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. 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 design
- Observational model
- Case-control
- Time perspective
- Prospective
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Athletes | – | Procedure: Cardiac magnetic Resonance study, Procedure: Blood testinghigh performing athletes |
Who may qualify
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Child, Adult, Older adult
- 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.
Key inclusion criteria (4 listed)
- Informed consent;
- feverish feeling with last 72 hours;
- active participation in competitive sports;
- history of recent viral exposure or flu-like symptoms.
Key exclusion criteria (3 listed)
- CMR Contraindications,
- chronic diseases affecting the heart,
- use of immuno-active drugs
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Cardiac magnetic Resonance studyfollow-up studies | Procedure or surgery | Athletes |
| Blood testingBlood sample tested for myocardial biomarkers | Procedure or surgery | Athletes |
Primary outcome
Left-ventricular systolic dysfunction, as defined by increased left ventricular end-diastolic volume
Time frame: 12 months
1 secondary outcome
Myocardial edema, fibrosis, inflammation, volumetry
Time frame: 12 months
Results and safety
The study was stopped early. Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 4 Oct 2011.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Matthias G Friedrich, MD, FESC principal investigator
University of Calgary
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Ventricular Function, Left, run by University of Calgary at 1 site in Canada.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 4 inclusion and 3 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: stopped early, as of the sponsor's last update on 4 Oct 2011. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Canada. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study was stopped early. Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Left-ventricular systolic dysfunction, as defined by increased left ventricular end-diastolic volume (time frame: 12 months). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 4 Oct 2011.