Athletes With Isolated Non-ischemic LGE With no Underlying "Labelled" CardiomyopathyEISCARNCT03780231
Effect of Intense Sport Practice in Athletes With Non-ischemic Scar
An observational study of Athletes With Isolated Non-ischemic LGE With no Underlying "Labelled" Cardiomyopathy, run by Rennes University Hospital at 6 sites in 6 countries.
Trial 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. Read more about this study
- Who is it for?
- Ages 15 years and older
- Conditions the study is for
- Athletes With Isolated Non-ischemic LGE With no Underlying "Labelled" Cardiomyopathy
- What is being tested?
- non-ischemic scar
- How many people
- 200 participants
- Where
- 6 sitesin 6 countries
- Study dates
- 5 Oct 2018to 5 Oct 2025
- Phase
- Observational
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 15 years and older
- All sexes
- No healthy volunteers
- Child, Adult, Older adult
Study population: 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.
Who may be able to join
- 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.
Who cannot join
- 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.
Trial locations and contacts
6 sites in 6 countries.
6 sites in 6 countries
Australia1 site, 1 recruiting
- Not yet recruiting
Baker IDI Heart and Diabetes Institute
Melbourne
André La Gerche, PH-PD
André La Gerche, PH-PD
Belgium1 site, 1 recruiting
- Not yet recruiting
University Hospital Gasthuisberg
Leuven
Guido Claassen, MD
Guido Claassen
France1 site, 1 recruiting
- Recruiting
CHU de Rennes
Rennes, 35033
Frederic FS SCHNELL, MD
Frederic SCHNELL, MD
Germany1 site, 1 recruiting
- Not yet recruiting
Saarland University
Saarbrücken
Jurgen Scharhag, PH-PD
Jurgen Scharhag, PH-PD
Luxembourg1 site, 1 recruiting
- Not yet recruiting
Hospital Center of Luxembourg
Luxembourg
Axel Urhausen, PH-PD
Axel Urhausen, PH-PD
United Kingdom1 site, 1 recruiting
- Not yet recruiting
St. George's University of London
London
Mickael Papadakis, MD
Mickael Papadakis, MD
About this study
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.
Read the 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.
- Being tested
- non-ischemic scar
- Keywords
- Athletes, Late gadolinium enhancement, fibrosis
- Medical subject headings
- Fibrosis
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
non-ischemic scarOther
non-ischemic LGE with no underlying "labelled" cardiomyopathy is detected on CMR
What is being measured
The primary outcome is the main question the study is designed to answer.
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
Measured: five years after inclusion
Secondary outcomes (3)
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)
Measured: five years after inclusion
Functional end-point
alteration of exercise capacity, defined by a reduction ≥10% of peak VO2, not explained by training changes
Measured: five years after inclusion
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.
Measured: five years after inclusion
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted19 Dec 2018
- Study start5 Oct 2018
- Primary completion5 Oct 2020 (estimated)
- Study completion5 Oct 2025 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Athletes With Isolated Non-ischemic LGE With no Underlying "Labelled" CardiomyopathyStudies of the same condition, open and under way.
- More trials run by Rennes University HospitalThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Cohort
- Time perspective
- Prospective
- Enrolment
- 200 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Rennes University Hospital
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Frederic FC SCHNELL, MD, Study director, Rennes University Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03780231
- Sponsor's protocol ID
- 35RC18_3026_EISCAR
- Acronym
- EISCAR
- Status last verified
- Dec 2018
- First submitted
- 17 Dec 2018
- Last updated
- 19 Dec 2018
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 19 Dec 2018. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Effect of Intense Sport Practice in Athletes With Non-ischemic Scar
- ClinicalTrials.gov ID
- NCT03780231
- Acronym / sponsor ID
- EISCAR / 35RC18_3026_EISCAR
- Keywords
- Athletes, Late gadolinium enhancement, fibrosis
- Study type
- Observational
- Recruitment status
- Unknown status
- Enrolment
- 200 participants (estimated)
- Lead sponsor
- Rennes University HospitalUniversity, hospital or other
- Study start
- 5 Oct 2018 (actual)
- Primary completion
- 5 Oct 2020 (estimated)
- Study completion
- 5 Oct 2025 (estimated)
- First posted
- 19 Dec 2018 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
Who may qualify
- Ages
- 15 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult, Older adult
- Study population
- 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.
Key inclusion criteria (3 listed)
- 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.
Key exclusion criteria (3 listed)
- 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.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| non-ischemic scarnon-ischemic LGE with no underlying "labelled" cardiomyopathy is detected on CMR | Other | – |
Primary outcome
Occurrence of a major cardiac event
Time frame: five years after inclusion
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
3 secondary outcomes
Morphological end-point
Time frame: five years after inclusion
Functional end-point
Time frame: five years after inclusion
Arrhythmic end-point
Time frame: five years after inclusion
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 19 Dec 2018.
Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Frederic FC SCHNELL, MD study director
Rennes University Hospital
6 sites in 6 countries: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Athletes With Isolated Non-ischemic LGE With no Underlying "Labelled" Cardiomyopathy, run by Rennes University Hospital at 6 sites in 6 countries.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 3 inclusion and 3 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: status not confirmed, as of the sponsor's last update on 19 Dec 2018. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 6 sites in Australia, Belgium, France, Germany, Luxembourg and 1 more country. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Kristell KC COAT (2 99 28 25 55 ext. +33, kristell.coat@chu-rennes.fr), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Occurrence of a major cardiac event (time frame: five years after inclusion). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 19 Dec 2018.