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

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

Status
UNKNOWN
Phases
Unknown
Study type
Observational
Source
ClinicalTrials.gov
Registry ID
NCT03780231
Acronym
EISCAR
Enrollment
200
Registered
2018-12-19
Start date
2018-10-05
Completion date
2025-10-05
Last updated
2018-12-19

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

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

Keywords

Athletes, Late gadolinium enhancement, fibrosis

Brief summary

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

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.

Interventions

OTHERnon-ischemic scar

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

Sponsors

Rennes University Hospital
Lead SponsorOTHER

Study design

Observational model
COHORT
Time perspective
PROSPECTIVE

Eligibility

Sex/Gender
ALL
Age
15 Years to No maximum
Healthy volunteers
No

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.

Design outcomes

Primary

MeasureTime frameDescription
Occurrence of a major cardiac eventfive years after inclusionDuring 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

Secondary

MeasureTime frameDescription
Functional end-pointfive years after inclusionalteration of exercise capacity, defined by a reduction ≥10% of peak VO2, not explained by training changes
Morphological end-pointfive years after inclusionAlteration 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)
Arrhythmic end-pointfive years after inclusionOccurrence 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.

Countries

Australia, Belgium, France, Germany, Luxembourg, United Kingdom

Contacts

Primary ContactKristell KC COAT
kristell.coat@chu-rennes.fr2 99 28 25 55
Backup ContactDirection de la recherche
drc@chu-rennes.fr2 99 28 25 55

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026