Effect of Intense Sport Practice in Athletes With Non-ischemic Scar
NCT ID: NCT03780231
Last Updated: 2018-12-19
Study Results
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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UNKNOWN
200 participants
OBSERVATIONAL
2018-10-05
2025-10-05
Brief Summary
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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 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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Keywords
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Study Design
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COHORT
PROSPECTIVE
Interventions
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non-ischemic scar
non-ischemic LGE with no underlying "labelled" cardiomyopathy is detected on CMR
Eligibility Criteria
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Inclusion Criteria
* 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
* Patients who refuse their participation in the study.
* Patients under legal protection or deprived of their liberty.
15 Years
ALL
No
Sponsors
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Rennes University Hospital
OTHER
Responsible Party
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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
University Hospital Gasthuisberg
Leuven, , Belgium
CHU de Rennes
Rennes, , France
Saarland University
Saarbrücken, , Germany
Hospital Center of Luxembourg
Luxembourg, , Luxembourg
St. George's University of London
London, , United Kingdom
Countries
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Central Contacts
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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