Clinical Trials Logo

Clinical Trial Details — Status: Completed

Administrative data

NCT number NCT03665324
Other study ID # 35RC17_3066
Secondary ID
Status Completed
Phase
First received
Last updated
Start date April 28, 2017
Est. completion date May 15, 2017

Study information

Verified date September 2018
Source Rennes University Hospital
Contact n/a
Is FDA regulated No
Health authority
Study type Observational

Clinical Trial Summary

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.


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.


Recruitment information / eligibility

Status Completed
Enrollment 100
Est. completion date May 15, 2017
Est. primary completion date May 15, 2017
Accepts healthy volunteers
Gender All
Age group 35 Years and older
Eligibility 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 Design


Related Conditions & MeSH terms


Intervention

Other:
Evaluation of the relationship between atrial remodeling evaluated by ECG and ETT with the occurrence of supraventricular arrhythmias
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.

Locations

Country Name City State
France Rennes University Hospital Rennes

Sponsors (1)

Lead Sponsor Collaborator
Rennes University Hospital

Country where clinical trial is conducted

France, 

Outcome

Type Measure Description Time frame Safety issue
Primary Study of atrial function by analysis of myocardial strain. Myocardial strain in extracted from ETT and compared between the two groups. At the inclusion day
See also
  Status Clinical Trial Phase
Recruiting NCT02158728 - Supraventricular Tachycardia Collection Study N/A