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

NCT ID: NCT03780231

Last Updated: 2018-12-19

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

UNKNOWN

Total Enrollment

200 participants

Study Classification

OBSERVATIONAL

Study Start Date

2018-10-05

Study Completion Date

2025-10-05

Brief Summary

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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.

Detailed Description

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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.

Conditions

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

Keywords

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Athletes Late gadolinium enhancement fibrosis

Study Design

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Observational Model Type

COHORT

Study Time Perspective

PROSPECTIVE

Interventions

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non-ischemic scar

non-ischemic LGE with no underlying "labelled" cardiomyopathy is detected on CMR

Intervention Type OTHER

Eligibility Criteria

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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.
Minimum Eligible Age

15 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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Rennes University Hospital

OTHER

Sponsor Role lead

Responsible Party

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Responsibility Role SPONSOR

Principal Investigators

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Frederic FC SCHNELL, MD

Role: STUDY_DIRECTOR

Rennes University Hospital

Locations

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Baker IDI Heart and Diabetes Institute

Melbourne, , Australia

Site Status NOT_YET_RECRUITING

University Hospital Gasthuisberg

Leuven, , Belgium

Site Status NOT_YET_RECRUITING

CHU de Rennes

Rennes, , France

Site Status RECRUITING

Saarland University

Saarbrücken, , Germany

Site Status NOT_YET_RECRUITING

Hospital Center of Luxembourg

Luxembourg, , Luxembourg

Site Status NOT_YET_RECRUITING

St. George's University of London

London, , United Kingdom

Site Status NOT_YET_RECRUITING

Countries

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Australia Belgium France Germany Luxembourg United Kingdom

Central Contacts

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Kristell KC COAT

Role: CONTACT

Phone: 2 99 28 25 55

Email: [email protected]

Direction de la recherche

Role: CONTACT

Phone: 2 99 28 25 55

Email: [email protected]

Facility Contacts

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André La Gerche, PH-PD

Role: primary

Guido Claassen, MD

Role: primary

Frederic FS SCHNELL, MD

Role: primary

Jurgen Scharhag, PH-PD

Role: primary

Axel Urhausen, PH-PD

Role: primary

Mickael Papadakis, MD

Role: primary

Other Identifiers

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35RC18_3026_EISCAR

Identifier Type: -

Identifier Source: org_study_id