Evaluating the effects of intense sports on athletes with non-ischemic heart scars
Effect of Intense Sport Practice in Athletes With Non-ischemic Scar
This study looks at how intense sports affect athletes with specific heart scars to see if they can safely compete and what factors might influence their health over five years.
Quick facts
| Study type | Observational |
|---|---|
| Enrollment | 200 (estimated) |
| Ages | 15 Years and up |
| Sex | All |
| Sponsor | Rennes University Hospital Academic / other |
| Locations | 6 sites (Melbourne and 5 other locations) |
| Trial ID | NCT03780231 on ClinicalTrials.gov |
What this trial studies
This observational study aims to assess the clinical outcomes of athletes who exhibit isolated non-ischemic late gadolinium enhancement (LGE) on cardiac imaging, without any underlying cardiomyopathy. Over a five-year follow-up period, the study will monitor these athletes to determine the prognostic factors associated with their condition and the impact of intense sports participation. The management and follow-up will be tailored by each participating center, with recommended annual assessments including clinical examinations and cardiac tests. The study seeks to clarify the implications of non-ischemic LGE findings for athletes' eligibility for competitive sports.
Who should consider this trial
Good fit: Ideal candidates for this study are athletes over the age of 15 who have been diagnosed with non-ischemic LGE on cardiac imaging.
Not a fit: Patients with clear underlying cardiac diseases that explain the LGE, such as hypertrophic cardiomyopathy or ischemic heart disease, will not benefit from this study.
Why it matters
Potential benefit: If successful, this study could provide critical insights into the safety of competitive sports participation for athletes with non-ischemic heart scars.
How similar studies have performed: While the specific focus on isolated non-ischemic LGE in athletes is relatively novel, similar studies have explored the implications of cardiac imaging findings in athletes, indicating potential for valuable insights.
Eligibility criteria
Show full inclusion / exclusion criteria
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.
Where this trial is running
Melbourne and 5 other locations
- Baker IDI Heart and Diabetes Institute — Melbourne, Australia (Not_yet_recruiting)
- University Hospital Gasthuisberg — Leuven, Belgium (Not_yet_recruiting)
- CHU de Rennes — Rennes, France (Recruiting)
- Saarland University — Sarrebruck, Germany (Not_yet_recruiting)
- Hospital Center of Luxembourg — Luxembourg, Luxembourg (Not_yet_recruiting)
- St. George's University of London — London, United Kingdom (Not_yet_recruiting)
Study contacts
- Study coordinator: Kristell KC COAT
- Email: kristell.coat@chu-rennes.fr
- Phone: 2 99 28 25 55
How to participate
- Review the eligibility criteria above with your treating physician.
- Visit the official trial page on ClinicalTrials.gov for the most current contact information and recruitment status.
- Contact the listed study coordinator or principal investigator to request pre-screening. Pre-screening is free and never obligates you to enroll.