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Trial details imported from ClinicalTrials.gov

For full trial details, please see the original record at https://clinicaltrials.gov/show/NCT03780231




Registration number
NCT03780231
Ethics application status
Date submitted
17/12/2018
Date registered
19/12/2018
Date last updated
19/12/2018

Titles & IDs
Public title
Effect of Intense Sport Practice in Athletes With Non-ischemic Scar
Scientific title
Effect of Intense Sport Practice in Athletes With Non-ischemic Scar
Secondary ID [1] 0 0
35RC18_3026_EISCAR
Universal Trial Number (UTN)
Trial acronym
EISCAR
Linked study record

Health condition
Health condition(s) or problem(s) studied:
Athletes With Isolated Non-ischemic LGE With no Underlying "Labelled" Cardiomyopathy 0 0
Condition category
Condition code

Intervention/exposure
Study type
Observational
Patient registry
Target follow-up duration
Target follow-up type
Description of intervention(s) / exposure
Other interventions - non-ischemic scar

Other interventions: non-ischemic scar
non-ischemic LGE with no underlying "labelled" cardiomyopathy is detected on CMR

Intervention code [1] 0 0
Other interventions
Comparator / control treatment
Control group

Outcomes
Primary outcome [1] 0 0
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
Timepoint [1] 0 0
five years after inclusion
Secondary outcome [1] 0 0
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)
Timepoint [1] 0 0
five years after inclusion
Secondary outcome [2] 0 0
Functional end-point - alteration of exercise capacity, defined by a reduction =10% of peak VO2, not explained by training changes
Timepoint [2] 0 0
five years after inclusion
Secondary outcome [3] 0 0
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.
Timepoint [3] 0 0
five years after inclusion

Eligibility
Key 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.
Minimum age
15 Years
Maximum age
No limit
Gender
Both males and females
Can healthy volunteers participate?
No
Key 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 design
Purpose
Duration
Selection
Timing
Prospective
Statistical methods / analysis

Recruitment
Recruitment status
Recruiting
Data analysis
Reason for early stopping/withdrawal
Other reasons
Date of first participant enrolment
Anticipated
Actual
Date of last participant enrolment
Anticipated
Actual
Date of last data collection
Anticipated
Actual
Sample size
Target
Accrual to date
Final
Recruitment in Australia
Recruitment state(s)
Recruitment hospital [1] 0 0
Baker IDI Heart and Diabetes Institute - Melbourne
Recruitment postcode(s) [1] 0 0
- Melbourne
Recruitment outside Australia
Country [1] 0 0
Belgium
State/province [1] 0 0
Leuven
Country [2] 0 0
France
State/province [2] 0 0
Rennes
Country [3] 0 0
Germany
State/province [3] 0 0
Sarrebruck
Country [4] 0 0
Luxembourg
State/province [4] 0 0
Luxembourg
Country [5] 0 0
United Kingdom
State/province [5] 0 0
London

Funding & Sponsors
Primary sponsor type
Other
Name
Rennes University Hospital
Address
Country

Ethics approval
Ethics application status

Summary
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.
Trial website
https://clinicaltrials.gov/show/NCT03780231
Trial related presentations / publications
Public notes

Contacts
Principal investigator
Name 0 0
Frederic FC SCHNELL, MD
Address 0 0
Rennes University Hospital
Country 0 0
Phone 0 0
Fax 0 0
Email 0 0
Contact person for public queries
Name 0 0
Kristell KC COAT
Address 0 0
Country 0 0
Phone 0 0
2 99 28 25 55
Fax 0 0
Email 0 0
kristell.coat@chu-rennes.fr
Contact person for scientific queries

Summary results
For IPD and results data, please see https://clinicaltrials.gov/show/NCT03780231