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Ventricular Arrhythmia After Myocarditis in Sportsman (ARYMYS)

U

University Hospital, Angers

Status

Enrolling

Conditions

Ventricular Arrythmia
Myocarditis Acute

Treatments

Diagnostic Test: Treadmill Stress test

Study type

Interventional

Funder types

Other

Identifiers

NCT03842592
2018-A03328-47

Details and patient eligibility

About

The study aims to assess the prevalence of ventricular rhythmic disorder after an acute myocarditis in sportsmen.

50 patients with acute myocarditis, confirmed by MRI, will be assessed by ECG Holter and Treadmill stress test during a 1-year follow-up.

Enrollment

50 estimated patients

Sex

All

Ages

18+ years old

Volunteers

No Healthy Volunteers

Inclusion criteria

  • acute myocarditis, diagnosed on the association of (a) recent viral infection (upper airway, gastro-intestinal) , (b) troponin increase, and (c) chest pain AND myocarditis confirmed by cardiac magnetic resonance 2 out of 3 Lake Louise criteria, either T2 hypersignal, early enhancement or late gadolinium enhancement.
  • regular physical activity, recreational or competitive: >=4 hours weekly
  • written informed consent

Exclusion criteria

  • coronary artery disease
  • acute inflammatory cardiomyopathy (sarcoidosis, fulminant myocarditis, Tako Tsubo, eosinophilic myocarditis, Lyme disease)
  • history of myocarditis
  • contra-indication to cardiac MRI
  • patient unable to perform a treadmill stress test

Trial design

Primary purpose

Screening

Allocation

N/A

Interventional model

Single Group Assignment

Masking

None (Open label)

50 participants in 1 patient group

To establish the rhythmic load of sports patients at a distance from a first episode of myocarditis.
Other group
Description:
Stress testing and 24-hour Holter ECG are the tools currently recommended for assessing rhythmic load and, consequently rhythmic risk. These investigations will be perform at 1 years after myocardite.
Treatment:
Diagnostic Test: Treadmill Stress test

Trial contacts and locations

4

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Central trial contact

Loïc BIERE, MD PhD; Fabrice PRUNIER, MD PhD

Data sourced from clinicaltrials.gov

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