NCT03665324

Brief 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.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
100

participants targeted

Target at P50-P75 for all trials

Timeline
Completed

Started Apr 2017

Shorter than P25 for all trials

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

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Study Timeline

Key milestones and dates

Study Start

First participant enrolled

April 28, 2017

Completed
17 days until next milestone

Primary Completion

Last participant's last visit for primary outcome

May 15, 2017

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

May 15, 2017

Completed
1.3 years until next milestone

First Submitted

Initial submission to the registry

September 5, 2018

Completed
6 days until next milestone

First Posted

Study publicly available on registry

September 11, 2018

Completed
Last Updated

September 11, 2018

Status Verified

September 1, 2018

Enrollment Period

17 days

First QC Date

September 5, 2018

Last Update Submit

September 7, 2018

Conditions

Keywords

Supraventricular arrhythmiasveteran athleteECGETT

Outcome Measures

Primary Outcomes (1)

  • 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

Study Arms (2)

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.

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

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.

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

Interventions

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 with Supraventricular arrhythmiasVeteran athletes without supraventricular arrhythmia

Eligibility Criteria

Age35 Years+
Sexall
Age GroupsAdult (18-64), Older Adult (65+)
Sampling MethodNon-Probability Sample
Study Population

Veteran athletes who consulted in the Sports Medicine Department between January 1, 2010 and January 1, 2017

You may qualify if:

  • Supraventricular arrhythmia group : Veteran athletes with documented paroxysmal supraventricular arrhythmias.
  • Control Group : Veteran athletes without documented supraventricular arrhythmia.

You may not qualify if:

  • 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.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Rennes University Hospital

Rennes, 35000, France

Location

Study Officials

  • frederic SCHNELL, MD

    Rennes University Hospital

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
observational
Observational Model
CASE CONTROL
Time Perspective
RETROSPECTIVE
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

September 5, 2018

First Posted

September 11, 2018

Study Start

April 28, 2017

Primary Completion

May 15, 2017

Study Completion

May 15, 2017

Last Updated

September 11, 2018

Record last verified: 2018-09

Data Sharing

IPD Sharing
Will not share

Locations