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

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

      • 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
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.

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

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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