An interventional study of Cardiac MRI and Applanation tonometry in Stiffness, Aortic, Cardiac Remodeling, Ventricular and Vascular Remodeling, sponsored by Central Hospital, Nancy, France. Completed at 1 site in France. Open to male participants aged 18 Years to 39 Years, including healthy volunteers. Per ClinicalTrials.gov, last updated 2020-02-11.
Sponsored by Central Hospital, Nancy, France · Not applicable, Interventional, and Basic science
Among 14 studies in Ventricular Remodeling with a site in France — 1 open to participants now, 3 under way, none of them phase 3. Ventricular Remodeling · France.
Among the 14 studies in Ventricular Remodeling with a site in France, this one is the 9th largest by enrollment of the 11 interventional ones, is one of 4 that started in 2017, is one of 10 with no phase, and was the 11th registered.
105 studies on the registry are indexed under Ventricular Remodeling; 24 are open to participants now.
This study's enrollment of 63 is below the median of 81 across 72 interventional studies indexed under Ventricular Remodeling.
Browse Ventricular Remodeling studies →1 of the 14 studies in Ventricular Remodeling with a site in France is open now, in 1 country. Each count lists the studies.
Of the 19 Ventricular Remodeling studies recruiting now, 6 (32%) set no upper age limit and 4 (21%) stop at 75 or younger; 0 take children under 18; 0 take healthy volunteers.
This study: 18 Years to 39 Years · male · healthy volunteers too.
The full table on the hub →14 studies; the count open now beside each. This study's row is marked.
First in 2009; this study’s year is marked. 4 started in 2017.
Median enrollment 100 across the 11 interventional studies, 350 across the 3 observational. Of the 10 that completed or were terminated, 0 (0%) have results posted.
2 of 14 have an industry lead sponsor. The 10 most frequent:
Central Hospital, Nancy, France is the lead sponsor of 798 studies on the registry; 186 are open to participants now.
Central Hospital, Nancy, France has 1 study filed under Ventricular Remodeling — fewer than ten, so there is no comparison to draw.
None of the studies under way reaches primary completion within a year.
Among the 14 studies in Ventricular Remodeling with a site in France, from their registry updates:
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.
Go through the criteria one by one — yes, no or not sure — and take the list to your doctor or the study team. Kept in this browser only.
to have carried out a clinical screening adapted to the research
*** Triathlete group:
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:
Exclusion Criteria:
Underlined terms in the criteria open these too. Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Weight in kilograms divided by height in metres squared. Example: 70 kg and 1.75 m gives 70 ÷ (1.75 × 1.75) ≈ 22.9.
What counts as overweight or obesity differs between countries (some use lower cut-offs), so go by the range the study states.
Before you join, the study team explains what taking part involves — its purpose, what happens, the risks and possible benefits — and answers your questions, so you can decide freely. Consent is usually recorded on a form (the informed consent form, ICF) signed by you or, where the law allows, by someone legally authorised to decide for you.
You can keep asking questions during the study, you are told of new information that matters, and you can choose to leave at any time.
A reason a treatment, test or procedure should not be given to a particular person, such as an allergy, another illness or a medicine they take.
BMI (body mass index)
Weight in kilograms divided by height in metres squared. Example: 70 kg and 1.75 m gives 70 ÷ (1.75 × 1.75) ≈ 22.9.
What counts as overweight or obesity differs between countries (some use lower cut-offs), so go by the range the study states.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Informed consent
Before you join, the study team explains what taking part involves — its purpose, what happens, the risks and possible benefits — and answers your questions, so you can decide freely. Consent is usually recorded on a form (the informed consent form, ICF) signed by you or, where the law allows, by someone legally authorised to decide for you.
You can keep asking questions during the study, you are told of new information that matters, and you can choose to leave at any time.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Contraindication
A reason a treatment, test or procedure should not be given to a particular person, such as an allergy, another illness or a medicine they take.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
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.
Device: Cardiac MRI · Device: Applanation tonometry
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.
Device: Cardiac MRI · Device: Applanation tonometry
Non injected cardiac MRI exam
Applanation tonometry and ECG
Aortic compliance in triathletes in mm2/mmHG
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)
Ran from Dec 2017 to primary completion in Mar 2019, 15 months.
How these figures are worked out, and which studies are left out of them.
This study is completed, as verified in Jan 2019. You cannot join it, but the record below documents what was studied.
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Central Hospital, Nancy, France →