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Study of the Aorta Adaptations to Exercise in Triathletes During Sports Season (CoATri) (CoATri)

Primary Purpose

Stiffness, Aortic, Cardiac Remodeling, Ventricular, Vascular Remodeling

Status

Completed

Phase

Not Applicable

Locations

France

Study Type

Interventional

Intervention

Cardiac MRI

Applanation tonometry

About this trial

This is an interventional basic science trial for Stiffness, Aortic focused on measuring Aortic compliance, Aortic distensibility, CMR, Triathletes, Ventriculo-atrial coupling

Eligibility Criteria

18 Years - 39 Years (Adult)MaleAccepts Healthy Volunteers

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

Sites / Locations

Central Hospital

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

Arm Label

Triathletes

Controls

Arm Description

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.

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.

Outcomes

Primary Outcome Measures

Aortic compliance in triathletes in mm2/mmHG

aortic compliance = pulsed pressure-to-absolute variation of aortic surface ratio

Secondary Outcome Measures

Full Information

NCT ID

NCT03356301

First Posted

November 22, 2017

Last Updated

February 10, 2020

Sponsor

Central Hospital, Nancy, France

1. Study Identification

Unique Protocol Identification Number

NCT03356301

Brief Title

Study of the Aorta Adaptations to Exercise in Triathletes During Sports Season (CoATri)

Acronym

CoATri

Official Title

Study of the Remodeling of the Ascending Aorta During the Sports Season in Long Distance Triathletes Versus Controls

Study Type

Interventional

2. Study Status

Record Verification Date

January 2019

Overall Recruitment Status

Completed

Study Start Date

December 1, 2017 (Actual)

Primary Completion Date

March 8, 2019 (Actual)

Study Completion Date

March 8, 2019 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title

Sponsor

Name of the Sponsor

Central Hospital, Nancy, France

4. Oversight

Studies a U.S. FDA-regulated Drug Product

Studies a U.S. FDA-regulated Device Product

Data Monitoring Committee

5. Study Description

Brief Summary

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study

Stiffness, Aortic, Cardiac Remodeling, Ventricular, Vascular Remodeling, Magnetic Resonance Imaging, Functional, Athletes

Keywords

Aortic compliance, Aortic distensibility, CMR, Triathletes, Ventriculo-atrial coupling

7. Study Design

Primary Purpose

Basic Science

Study Phase

Not Applicable

Interventional Study Model

Parallel Assignment

Masking

None (Open Label)

Allocation

Non-Randomized

Enrollment

63 (Actual)

8. Arms, Groups, and Interventions

Arm Title

Triathletes

Arm Type

Experimental

Arm Description

Arm Title

Controls

Arm Type

Experimental

Arm Description

Intervention Type

Device

Intervention Name(s)

Cardiac MRI

Intervention Description

Non injected cardiac MRI exam

Intervention Type

Device

Intervention Name(s)

Applanation tonometry

Intervention Description

Applanation tonometry and ECG

Primary Outcome Measure Information:

Title

Aortic compliance in triathletes in mm2/mmHG

Description

aortic compliance = pulsed pressure-to-absolute variation of aortic surface ratio

Time Frame

at baseline, at the fitness peak (6 to 10 months later) and at recovery (3 to 6 months after the fitness peak)

10. Eligibility

Sex

Male

Minimum Age & Unit of Time

18 Years

Maximum Age & Unit of Time

39 Years

Accepts Healthy Volunteers

Eligibility Criteria

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

Overall Study Officials:

First Name & Middle Initial & Last Name & Degree

Damien MANDRY, MD,PhD

Organizational Affiliation

CHRU de Nancy

Official's Role

Principal Investigator

First Name & Middle Initial & Last Name & Degree

Anne-Charlotte DUPONT, MD

Organizational Affiliation

CHRU de Nancy

Official's Role

Principal Investigator

Facility Information:

Facility Name

Central Hospital

City

Nancy

ZIP/Postal Code

54000

Country

France

12. IPD Sharing Statement

Citations:

PubMed Identifier

27838232

Citation

Dupont AC, Poussel M, Hossu G, Marie PY, Chenuel B, Felblinger J, Mandry D. Aortic compliance variation in long male distance triathletes: A new insight into the athlete's artery? J Sci Med Sport. 2017 Jun;20(6):539-542. doi: 10.1016/j.jsams.2016.10.009. Epub 2016 Oct 29.

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Study of the Aorta Adaptations to Exercise in Triathletes During Sports Season (CoATri)

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