Effect of Intense Sport Practice in Athletes With Non-ischemic Scar

Last updated: December 17, 2018
Sponsor: Rennes University Hospital
Overall Status: Active - Recruiting

Phase

N/A

Condition

Circulation Disorders

Treatment

N/A

Clinical Study ID

NCT03780231
35RC18_3026_EISCAR
  • Ages > 15
  • All Genders

Study Summary

The prognostic relevance of isolated non-ischemic LGE (i.e. with no underlying "labelled" cardiomyopathy) is unclear, and current guidelines to not state on the clearance of athlete with this type of findings as regards to competitive or intense sport practice.

The principal objective of the study is to evaluate during a five-years follow up, the clinical outcome of athletes with this kind of findings. The secondary objective is the determination of prognostic factors. The management and follow-up of the athletes will be let at the appraisal of each center.

Eligibility Criteria

Inclusion

Inclusion Criteria:

  • Any athlete, aged of more than 15 years, symptomatic or not,

  • in whom non-ischemic LGE with no underlying "labelled" cardiomyopathy is detected onCMR. Scare of an acute myocarditis will also be included. Athletes will be defined by a practice of ≥4 hours/week of sport activity and/orcompetitive sport activity at the time of the assessment which triggered the realization ofthe 1st CMR.

Exclusion

Exclusion Criteria:

  • Athletes with any unequivocal cardiac disease that might explain the LGE (i.e.hypertrophic cardiomyopathy, ischemic cardiac disease). In case of borderline ordoubtful diagnosis the athlete can still be included (for example an athlete with adilated LV and borderline function, or with borderline wall thickness).

  • Patients who refuse their participation in the study.

  • Patients under legal protection or deprived of their liberty.

Study Design

Total Participants: 200
Study Start date:
October 05, 2018
Estimated Completion Date:
October 05, 2025

Study Description

The presence of a scar, assessed by late gadolinium enhancement (LGE) on cardiac resonance imaging (CMR), is associated with a poor prognosis in patients with ischemic heart disease or cardiomyopathy. But the prognostic relevance of isolated non-ischemic LGE (i.e. with no underlying "labelled" cardiomyopathy) is unclear, and current guidelines do not state on the clearance of athlete with this type of findings as regards to competitive or intense sport practice.

The objective of the study is to evaluate the clinical outcome of athletes with isolated non-ischemic LGE with no underlying "labelled" cardiomyopathy during a five-years follow-up. The secondary objective is the determination of prognostic factors based on the baseline inclusion data: indication of CMR (i.e. symptoms, abnormal ECG, presence and morphology of arrhythmias, abnormal echocardiography); localization and amount of LGE, left and right ventricular geometry and function, characteristics of sport practice (amount, type, competition).

The management of the athletes will be let at the appraisal of each centre, as regards to the initial assessment, the follow-up and the medical clearance for competitive sports participation. Nevertheless, due to the absence of consensus, we propose that the patient should at least undergo clinical examination, ECG, echocardiography, cardiopulmonary exercise test (CPET) and holter ECG each year. A CMR should be performed at one and five years.

Connect with a study center

  • Baker IDI Heart and Diabetes Institute

    Melbourne,
    Australia

    Site Not Available

  • University Hospital Gasthuisberg

    Leuven,
    Belgium

    Site Not Available

  • CHU de Rennes

    Rennes, 35033
    France

    Active - Recruiting

  • Saarland University

    Sarrebruck,
    Germany

    Site Not Available

  • Hospital Center of Luxembourg

    Luxembourg,
    Luxembourg

    Site Not Available

  • St. George's University of London

    London,
    United Kingdom

    Site Not Available

Not the study for you?

Let us help you find the best match. Sign up as a volunteer and receive email notifications when clinical trials are posted in the medical category of interest to you.