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Trial details imported from ClinicalTrials.gov
For full trial details, please see the original record at
https://clinicaltrials.gov/study/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
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Scientific title
Effect of Intense Sport Practice in Athletes With Non-ischemic Scar
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Secondary ID [1]
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35RC18_3026_EISCAR
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Universal Trial Number (UTN)
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Trial acronym
EISCAR
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Linked study record
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Health condition
Health condition(s) or problem(s) studied:
Athletes With Isolated Non-ischemic LGE With no Underlying "Labelled" Cardiomyopathy
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Condition category
Condition code
Intervention/exposure
Study type
Observational
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Patient registry
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Target follow-up duration
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Target follow-up type
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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
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Intervention code [1]
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Other interventions
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Comparator / control treatment
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Control group
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Outcomes
Primary outcome [1]
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Occurrence of a major cardiac event
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Assessment method [1]
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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
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Timepoint [1]
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five years after inclusion
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Secondary outcome [1]
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Morphological end-point
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Assessment method [1]
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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)
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Timepoint [1]
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five years after inclusion
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Secondary outcome [2]
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Functional end-point
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Assessment method [2]
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alteration of exercise capacity, defined by a reduction =10% of peak VO2, not explained by training changes
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Timepoint [2]
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five years after inclusion
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Secondary outcome [3]
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Arrhythmic end-point
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Assessment method [3]
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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.
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Timepoint [3]
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five years after inclusion
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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.
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Minimum age
15
Years
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Maximum age
No limit
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Sex
Both males and females
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Can healthy volunteers participate?
No
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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.
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Study design
Purpose
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Duration
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Selection
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Timing
Prospective
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Statistical methods / analysis
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Recruitment
Recruitment status
Recruiting
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Data analysis
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Reason for early stopping/withdrawal
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Other reasons
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Date of first participant enrolment
Anticipated
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Actual
5/10/2018
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Date of last participant enrolment
Anticipated
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Actual
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Date of last data collection
Anticipated
5/10/2025
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Actual
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Sample size
Target
200
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Accrual to date
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Final
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Recruitment in Australia
Recruitment state(s)
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Recruitment hospital [1]
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Baker IDI Heart and Diabetes Institute - Melbourne
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Recruitment postcode(s) [1]
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- Melbourne
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Recruitment outside Australia
Country [1]
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Belgium
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State/province [1]
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Leuven
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Country [2]
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France
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State/province [2]
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Rennes
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Country [3]
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Germany
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State/province [3]
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Sarrebruck
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Country [4]
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Luxembourg
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State/province [4]
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Luxembourg
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Country [5]
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United Kingdom
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State/province [5]
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London
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Funding & Sponsors
Primary sponsor type
Other
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Name
Rennes University Hospital
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Address
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Country
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Ethics approval
Ethics application status
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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.
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Trial website
https://clinicaltrials.gov/study/NCT03780231
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Trial related presentations / publications
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Public notes
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Contacts
Principal investigator
Name
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Frederic FC SCHNELL, MD
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Address
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Rennes University Hospital
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Country
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Phone
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Fax
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Email
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Contact person for public queries
Name
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Kristell KC COAT
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Address
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Country
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Phone
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2 99 28 25 55
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Fax
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Email
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[email protected]
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Contact person for scientific queries
No information has been provided regarding IPD availability
What supporting documents are/will be available?
No Supporting Document Provided
Results publications and other study-related documents
No documents have been uploaded by study researchers.
Results not provided in
https://clinicaltrials.gov/study/NCT03780231
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