- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT03356301
Study of the Aorta Adaptations to Exercise in Triathletes During Sports Season (CoATri) (CoATri)
February 10, 2020 updated by: Central Hospital, Nancy, France
Study of the Remodeling of the Ascending Aorta During the Sports Season in Long Distance Triathletes Versus Controls
Regular sustained physical activity creates a cardiac remodelling : it is athlete's heart.
In our preliminary work published in 2016, the investigators demonstrated in a small population of triathletes that there is also a vascular remodelling named athlete's artery.
Moreover, the investigators know that left ventricle and aorta behave together like a couple.
So they want to study by Cardiovascular Magnetic Resonance Imaging the impact of triathlon on the cardiac AND aortic remodelling.
Study Overview
Status
Completed
Conditions
Intervention / Treatment
Study Type
Interventional
Enrollment (Actual)
63
Phase
- Not Applicable
Contacts and Locations
This section provides the contact details for those conducting the study, and information on where this study is being conducted.
Study Locations
-
-
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Nancy, France, 54000
- Central Hospital
-
-
Participation Criteria
Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.
Eligibility Criteria
Ages Eligible for Study
18 years to 39 years (ADULT)
Accepts Healthy Volunteers
Yes
Genders Eligible for Study
Male
Description
Inclusion Criteria:
- to be enrolled in a social security plan.
- to have a BMI between 18,5 and 25 kg/m²
- to have received full information on the organization of the research and having signed its informed consent
to have carried out a clinical screening adapted to the research
*** Triathlete group:
- to have a minimum performance level: between 2h and 2h45 on an M triathlon during the past year (provide proof),
- to participate in 2018 in a long distance triathlon, i. e. at least distance L
to have a defined training volume: less than 8 hours per week during the winter months and between 10 and 15 hours per week in preparation of the objective
***Control group:
- to have no more than 150 minutes of moderate physical activity per week (footing, brisk walking, cycling, etc.).
Exclusion Criteria:
- Persons referred to in Articles L. 1121-5 to L. 1121-8 and L1122-2 of the Public Health Code
- Cardiovascular history including Ii.e. known heart rhythm disorders
- Chronic disease: diabetes, high blood pressure...
- Long-term drug therapies that may modify cardiovascular remodeling such as Conversion Enzyme Inhibitor, Angiotensin II Receptor Antagonist,
- Active smoking, even if occasional
- Contraindication to MRI
Study Plan
This section provides details of the study plan, including how the study is designed and what the study is measuring.
How is the study designed?
Design Details
- Primary Purpose: BASIC_SCIENCE
- Allocation: NON_RANDOMIZED
- Interventional Model: PARALLEL
- Masking: NONE
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
|---|---|
|
EXPERIMENTAL: Triathletes
Every triathlete will realize three cardiac MRI exams.The second of those will be done at the fitness peak, 2-3 weeks before the main objective of the sports season.
Training will be increased between the study beginning and the first MRI, and the second exam.
After each cardiac MRI, an applanation tonometry examination will aslo be performed.
|
Non injected cardiac MRI exam
Applanation tonometry and ECG
|
|
EXPERIMENTAL: Controls
Every control subject will also realize three cardiac MRI exams if possible at the same time as the triathletes.They must be not engaged in physical activity more than 150 minutes a week on average.
After each cardiac MRI, an applanation tonometry examination will aslo be performed.
|
Non injected cardiac MRI exam
Applanation tonometry and ECG
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
|---|---|---|
|
Aortic compliance in triathletes in mm2/mmHG
Time Frame: at baseline, at the fitness peak (6 to 10 months later) and at recovery (3 to 6 months after the fitness peak)
|
aortic compliance = pulsed pressure-to-absolute variation of aortic surface ratio
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at baseline, at the fitness peak (6 to 10 months later) and at recovery (3 to 6 months after the fitness peak)
|
Collaborators and Investigators
This is where you will find people and organizations involved with this study.
Sponsor
Investigators
- Principal Investigator: Damien MANDRY, MD,PhD, CHRU de Nancy
- Principal Investigator: Anne-Charlotte DUPONT, MD, CHRU de Nancy
Publications and helpful links
The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.
Study record dates
These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.
Study Major Dates
Study Start (ACTUAL)
December 1, 2017
Primary Completion (ACTUAL)
March 8, 2019
Study Completion (ACTUAL)
March 8, 2019
Study Registration Dates
First Submitted
November 22, 2017
First Submitted That Met QC Criteria
November 28, 2017
First Posted (ACTUAL)
November 29, 2017
Study Record Updates
Last Update Posted (ACTUAL)
February 11, 2020
Last Update Submitted That Met QC Criteria
February 10, 2020
Last Verified
January 1, 2019
More Information
Terms related to this study
Additional Relevant MeSH Terms
Other Study ID Numbers
- 2017-A01872-51
Drug and device information, study documents
Studies a U.S. FDA-regulated drug product
No
Studies a U.S. FDA-regulated device product
No
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
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