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

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.

Study Overview

• Status: Recruiting
• Conditions: Athletes With Isolated Non-ischemic LGE With no Underlying "Labelled" Cardiomyopathy
• Intervention / Treatment: Other: non-ischemic scar

Detailed 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.

• Study Type: Observational
• Enrollment (Anticipated): 200

Contacts and Locations

• Study Contact: Name: Kristell KC COAT; Phone Number: +33 2 99 28 25 55; Email: kristell.coat@chu-rennes.fr

Study Locations

• Australia
  • Melbourne, Australia
    • Not yet recruiting
    • Baker IDI Heart and Diabetes Institute
    • Contact: André La Gerche, PH-PD
    • Principal Investigator: André La Gerche, PH-PD
• Belgium
  • Leuven, Belgium
    • Not yet recruiting
    • University Hospital Gasthuisberg
    • Contact: Guido Claassen, MD
    • Principal Investigator: Guido Claassen
• France
  • Rennes, France, 35033
    • Recruiting
    • CHU de Rennes
    • Contact: Frederic FS SCHNELL, MD
    • Principal Investigator: Frederic SCHNELL, MD
• Germany
  • Sarrebruck, Germany
    • Not yet recruiting
    • Saarland University
    • Contact: Jurgen Scharhag, PH-PD
    • Principal Investigator: Jurgen Scharhag, PH-PD
• Luxembourg
  • Luxembourg, Luxembourg
    • Not yet recruiting
    • Hospital Center of Luxembourg
    • Contact: Axel Urhausen, PH-PD
    • Principal Investigator: Axel Urhausen, PH-PD
• United Kingdom
  • London, United Kingdom
    • Not yet recruiting
    • St. George's University of London
    • Contact: Mickael Papadakis, MD
    • Principal Investigator: Mickael Papadakis, MD

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 15 years and older (ADULT, OLDER_ADULT, CHILD)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

• Sampling Method: Probability Sample

Study Population

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.

Description

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.

Study Plan

How is the study designed?

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Occurrence of a major cardiac event	During a follow-up of 5 years, occurrence of a major cardiac event defined by either: death, death of cardiovascular cause; hospitalization for cardiac event; any major arrhythmic event defined by arrhythmic cardiac arrest, sustained ventricular tachycard	five years after inclusion

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Morphological end-point	Alteration of left ventricular (LV) function defined by a decrease in LVEF as compared to the initial evaluation (≥10%, or occurrence of a new wall motion abnormality assessed the same imaging technic, i.e. echocardiography or CMR)	five years after inclusion
Functional end-point	alteration of exercise capacity, defined by a reduction ≥10% of peak VO2, not explained by training changes	five years after inclusion
Arrhythmic end-point	Occurrence of a non-sustained VT (NSVT), defined as a tachycardia originating in the ventricle >100 beats/min and lasting ≥3 beats but less than 30 seconds.	five years after inclusion

Collaborators and Investigators

• Sponsor: Rennes University Hospital
• Investigators: Study Director: Frederic FC SCHNELL, MD, Rennes University Hospital

Study record dates

Study Major Dates

• Study Start (ACTUAL): October 5, 2018
• Primary Completion (ANTICIPATED): October 5, 2020
• Study Completion (ANTICIPATED): October 5, 2025

Study Registration Dates

• First Submitted: December 17, 2018
• First Submitted That Met QC Criteria: December 17, 2018
• First Posted (ACTUAL): December 19, 2018

Study Record Updates

• Last Update Posted (ACTUAL): December 19, 2018
• Last Update Submitted That Met QC Criteria: December 17, 2018
• Last Verified: December 1, 2018

More Information

Terms related to this study

• Keywords: fibrosis; Athletes; Late gadolinium enhancement
• Additional Relevant MeSH Terms: Heart Diseases; Cardiovascular Diseases; Cardiomyopathies
• Other Study ID Numbers: 35RC18_3026_EISCAR

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No