- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT03665324
Atrial Function and Supraventricular Arrhythmia of the Veteran Athlete. (FA2V)
Supraventricular arrhythmias (including atrial fibrillation) are the most common arrhythmias of the veteran athlete and have a major impact in terms of morbidity and mortality. Although moderate sports practice has been shown to decrease the occurrence of these arrhythmias, it has also been shown that very intense athletic activity is associated with an increased risk of developing atrial fibrillation. The pathophysiological mechanism is not clearly understood. However, it has already been shown that intensive sports practice leads to electrical and morphological atrial remodeling, which could be the cause of the occurrence of supraventricular arrhythmias for these athletes.
For sedentary patients, two major tools predict the risk of the onset of supraventricular arrhythmia: the electrocardiogram (ECG) and transthoracic echocardiography (ETT), particularly with the study of atrial function by the analysis of myocardial deformities.
Study Overview
Status
Conditions
Detailed Description
No studies have tested these two tools for the evaluation of atrial remodeling of the veteran athlete to predict which ones are at risk of developing supraventricular arrhythmias.
However, the identification of predictive factors would make it possible to identify at-risk athletes and thus provide them with adapted sporting practice advice and personalized follow-up.
The aim of the study is to evaluate the relationship between atrial remodeling assessed by ECG and ETT with the occurrence of supraventricular arrhythmia by comparing an athlete group with supraventricular arrhythmia with a control group of healthy athletes.
Study Type
Enrollment (Actual)
Contacts and Locations
Study Locations
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Rennes, France, 35000
- Rennes University Hospital
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Participation Criteria
Eligibility Criteria
Ages Eligible for Study
Accepts Healthy Volunteers
Genders Eligible for Study
Sampling Method
Study Population
Description
Inclusion Criteria:
- Supraventricular arrhythmia group : Veteran athletes with documented paroxysmal supraventricular arrhythmias.
- Control Group : Veteran athletes without documented supraventricular arrhythmia.
Exclusion Criteria:
- Any cardiopathy (valvulopathy, coronary heart disease, etc.).
- Minor patients,
- Major patients subject to legal protection (legal safeguards, guardianship)
- Persons deprived of their liberty
- Patients opposed to the use of their personal data.
Study Plan
How is the study designed?
Design Details
- Observational Models: Case-Control
- Time Perspectives: Retrospective
Cohorts and Interventions
Group / Cohort |
Intervention / Treatment |
---|---|
Veteran athletes with Supraventricular arrhythmias
Subjects who consulted in the Sports Medicine Department between January 1, 2010 and January 1, 2017 Veteran athletes (age> 35 years) with documented paroxysmal supraventricular arrhythmias.
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Subjects will be retrospectively retrieved from the Sport Medicine Service of Rennes University Hospital database. Medical data will then be collected from the athletes' medical records. The ECG present in the medical file will be reinterpreted to obtain the resting heart rate, the amplitude of the P wave, the morphology of the P wave and the duration of the PR space. The data from the stress test will be found from reports in the medical records: resting heart rate, maximum heart rate, sustained peak load, arrhythmia during the test. ETTs will be retrieved from the local server. They will be reinterpreted to collect anatomical and functional cardiac data necessary for the study. |
Veteran athletes without supraventricular arrhythmia
Subjects who consulted in the Sports Medicine Department between January 1, 2010 and January 1, 2017 Veteran athletes (age> 35 years) without documented supraventricular arrhythmia.
|
Subjects will be retrospectively retrieved from the Sport Medicine Service of Rennes University Hospital database. Medical data will then be collected from the athletes' medical records. The ECG present in the medical file will be reinterpreted to obtain the resting heart rate, the amplitude of the P wave, the morphology of the P wave and the duration of the PR space. The data from the stress test will be found from reports in the medical records: resting heart rate, maximum heart rate, sustained peak load, arrhythmia during the test. ETTs will be retrieved from the local server. They will be reinterpreted to collect anatomical and functional cardiac data necessary for the study. |
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
Study of atrial function by analysis of myocardial strain.
Time Frame: At the inclusion day
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Myocardial strain in extracted from ETT and compared between the two groups.
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At the inclusion day
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Collaborators and Investigators
Sponsor
Investigators
- Principal Investigator: frederic SCHNELL, MD, Rennes University Hospital
Study record dates
Study Major Dates
Study Start (Actual)
Primary Completion (Actual)
Study Completion (Actual)
Study Registration Dates
First Submitted
First Submitted That Met QC Criteria
First Posted (Actual)
Study Record Updates
Last Update Posted (Actual)
Last Update Submitted That Met QC Criteria
Last Verified
More Information
Terms related to this study
Additional Relevant MeSH Terms
Other Study ID Numbers
- 35RC17_3066
Plan for Individual participant data (IPD)
Plan to Share Individual Participant Data (IPD)?
Drug and device information, study documents
Studies a U.S. FDA-regulated drug product
Studies a U.S. FDA-regulated device product
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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