Athletes With Isolated Non-ischemic LGE With no Underlying Labelled Cardiomyopathy Clinical Trial
— EISCAROfficial title:
Effect of Intense Sport Practice in Athletes With Non-ischemic Scar
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.
| Status | Recruiting |
| Enrollment | 200 |
| Est. completion date | October 5, 2025 |
| Est. primary completion date | October 5, 2020 |
| Accepts healthy volunteers | No |
| Gender | All |
| Age group | 15 Years and older |
| Eligibility |
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. |
| Country | Name | City | State |
|---|---|---|---|
| Australia | Baker IDI Heart and Diabetes Institute | Melbourne | |
| Belgium | University Hospital Gasthuisberg | Leuven | |
| France | CHU de Rennes | Rennes | |
| Germany | Saarland University | Sarrebruck | |
| Luxembourg | Hospital Center of Luxembourg | Luxembourg | |
| United Kingdom | St. George's University of London | London |
| Lead Sponsor | Collaborator |
|---|---|
| Rennes University Hospital |
Australia, Belgium, France, Germany, Luxembourg, United Kingdom,
| Type | Measure | Description | Time frame | Safety issue |
|---|---|---|---|---|
| Primary | 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 | 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 | |
| Secondary | Functional end-point | alteration of exercise capacity, defined by a reduction =10% of peak VO2, not explained by training changes | five years after inclusion | |
| Secondary | 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 |