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

R

Rennes University Hospital

Status

Enrolling

Conditions

Athletes With Isolated Non-ischemic LGE With no Underlying "Labelled" Cardiomyopathy

Treatments

Other: non-ischemic scar

Study type

Observational

Funder types

Other

Identifiers

NCT03780231
35RC18_3026_EISCAR

Details and patient eligibility

About

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.

Full 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.

Enrollment

200 estimated patients

Sex

All

Ages

15+ years old

Volunteers

No Healthy Volunteers

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 on CMR. Scare of an acute myocarditis will also be included.

Athletes will be defined by a practice of ≥4 hours/week of sport activity and/or competitive sport activity at the time of the assessment which triggered the realization of the 1st CMR.

Exclusion criteria

  • Athletes with any unequivocal cardiac disease that might explain the LGE (i.e. hypertrophic cardiomyopathy, ischemic cardiac disease). In case of borderline or doubtful diagnosis the athlete can still be included (for example an athlete with a dilated 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.

Trial contacts and locations

6

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Central trial contact

Direction de la recherche; Kristell KC COAT

Data sourced from clinicaltrials.gov

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