Stiffness, AorticCoATriNCT03356301
Study of the Aorta Adaptations to Exercise in Triathletes During Sports Season (CoATri)
A study testing Cardiac MRI and Applanation tonometry in people with Stiffness, Aortic and Cardiac Remodeling, Ventricular, run by Central Hospital, Nancy, France at 1 site in France.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 to 39 years, men onlyHealthy volunteers can take part
- Conditions the study is for
- Stiffness, Aortic, Cardiac Remodeling, Ventricular, Vascular Remodeling
- What is being tested?
- Cardiac MRI and Applanation tonometry
- Type of treatment
- Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 63 participants
- Where
- 1 siteFrance
- Study dates
- 1 Dec 2017to 8 Mar 2019
- Phase
- Interventional
- 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 18 to 39 years
- Men only
- Healthy volunteers accepted
- Adult
Who may be able to join
- 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),
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- 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.).
Who cannot join
- 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
Trial locations and contacts
1 site in 1 country.
About this study
Official title: 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.
- Conditions
- Stiffness, Aortic, Cardiac Remodeling, Ventricular, Vascular Remodeling, Magnetic Resonance Imaging, Functional, Athletes
- Being tested
- Cardiac MRI, Applanation tonometry
- Keywords
- Aortic compliance, Aortic distensibility, CMR, Triathletes, Ventriculo-atrial coupling
- Medical subject headings
- Ventricular Remodeling, Vascular Remodeling
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Cardiac MRIDevice
Non injected cardiac MRI exam
Applanation tonometryDevice
Applanation tonometry and ECG
| Study group | Role | What they receive |
|---|---|---|
| Triathletes | Experimental | 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. Receives: Device: Cardiac MRI; Device: Applanation tonometry |
| Controls | Experimental | 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. Receives: Device: Cardiac MRI; Device: Applanation tonometry |
What is being measured
The primary outcome is the main question the study is designed to answer.
Aortic compliance in triathletes in mm2/mmHG
aortic compliance = pulsed pressure-to-absolute variation of aortic surface ratio
Measured: at baseline, at the fitness peak (6 to 10 months later) and at recovery (3 to 6 months after the fitness peak)
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted29 Nov 2017
- Study start1 Dec 2017
- Primary completion8 Mar 2019
- Study completion8 Mar 2019
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Stiffness, AorticStudies of the same condition, open and under way.
- More trials run by Central Hospital, Nancy, FranceThe 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
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Basic science
- Allocation
- Non-randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 63 participants (actual)
Sponsor and investigators
- Lead sponsor
- Central Hospital, Nancy, France
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Damien MANDRY, MD,PhD, Principal investigator, CHRU de NancyAnne-Charlotte DUPONT, MD, Principal investigator, CHRU de Nancy
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03356301
- Sponsor's protocol ID
- 2017-A01872-51
- Acronym
- CoATri
- Status last verified
- Jan 2019
- First submitted
- 22 Nov 2017
- Last updated
- 11 Feb 2020
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Publications
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.
PubMed 27838232
Study at a glance
From the registry record, last updated by the sponsor on 11 Feb 2020. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Study of the Remodeling of the Ascending Aorta During the Sports Season in Long Distance Triathletes Versus Controls
- ClinicalTrials.gov ID
- NCT03356301
- Acronym / sponsor ID
- CoATri / 2017-A01872-51
- Conditions
- Stiffness, Aortic, Cardiac Remodeling, Ventricular, Vascular Remodeling, Magnetic Resonance Imaging, Functional, Athletes
- Keywords
- Aortic compliance, Aortic distensibility, CMR, Triathletes, Ventriculo-atrial coupling
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 63 participants (actual)
- Lead sponsor
- Central Hospital, Nancy, FranceUniversity, hospital or other
- Study start
- 1 Dec 2017 (actual)
- Primary completion
- 8 Mar 2019 (actual)
- Study completion
- 8 Mar 2019 (actual)
- First posted
- 29 Nov 2017 (actual)
- 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.
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 design
- Primary purpose
- Basic science
- Allocation
- Non-randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Triathletes | Experimental | Device: Cardiac MRI, Device: Applanation tonometryEvery 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. |
| Controls | Experimental | Device: Cardiac MRI, Device: Applanation tonometryEvery 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. |
Who may qualify
- Ages
- 18 to 39 years
- Sex
- Male only
- Healthy volunteers
- Accepted
- Age groups
- Adult
Key inclusion criteria (10 listed)
- 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
- to have a minimum performance level: between 2h and 2h45 on an M triathlon during the past year (provide proof),
Key exclusion criteria (6 listed)
- 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
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 MRINon injected cardiac MRI exam | Device | Controls, Triathletes |
| Applanation tonometryApplanation tonometry and ECG | Device | Controls, Triathletes |
Primary outcome
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
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 11 Feb 2020.
- Background: PubMed 27838232Dupont 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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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.
Damien MANDRY, MD,PhD principal investigator
CHRU de Nancy
Anne-Charlotte DUPONT, MD principal investigator
CHRU de Nancy
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Cardiac MRI and Applanation tonometry in people with Stiffness, Aortic and Cardiac Remodeling, Ventricular, run by Central Hospital, Nancy, France at 1 site in France.
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 10 inclusion and 6 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: finished, as of the sponsor's last update on 11 Feb 2020. 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 France. 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 is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
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?
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)). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT03356301, which also lists 1 linked publication.
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 11 Feb 2020.