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Ventricular Arrhythmia After Myocarditis in Sportsman (ARYMYS)

Primary Purpose

Myocarditis Acute, Ventricular Arrythmia

Status
Unknown status
Phase
Not Applicable
Locations
Study Type
Interventional
Intervention
Treadmill Stress test
Sponsored by
University Hospital, Angers
About
Eligibility
Locations
Outcomes
Full info

About this trial

This is an interventional screening trial for Myocarditis Acute

Eligibility Criteria

18 Years - undefined (Adult, Older Adult)All SexesDoes not accept 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

Sites / Locations

    Outcomes

    Primary Outcome Measures

    Complex ventricular arrhythmia
    any ventricular tachycardia (triplet or more), ventricular fibrillation (observed on ECG Holter or during stress test)

    Secondary Outcome Measures

    In-hospital ventricular arrhythmia
    any ventricular tachycardia (triplet or more), ventricular fibrillation, recorded on ECG monitoring
    Left Ventricular remodeling
    Change in LV volumes during time
    Left ventricular fibrosis
    Change in interstitial fibrosis by T1 mapping cardiac magnetic resonnance
    Major adverse cardio vascular event
    CV death, sudden cardiac death, cardiac graft or haemodynamic support, hospitalisation for heart failure, new event of myocarditis
    return to physical activity
    defined as at least 75% of exercising time (in hours per week)

    Full Information

    First Posted
    January 28, 2019
    Last Updated
    February 12, 2019
    Sponsor
    University Hospital, Angers
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    1. Study Identification

    Unique Protocol Identification Number
    NCT03842592
    Brief Title
    Ventricular Arrhythmia After Myocarditis in Sportsman
    Acronym
    ARYMYS
    Official Title
    Quantification of Ventricular Arrhythmia After Myocarditis in Sportsman
    Study Type
    Interventional

    2. Study Status

    Record Verification Date
    February 2019
    Overall Recruitment Status
    Unknown status
    Study Start Date
    April 2019 (Anticipated)
    Primary Completion Date
    April 2021 (Anticipated)
    Study Completion Date
    April 2022 (Anticipated)

    3. Sponsor/Collaborators

    Responsible Party, by Official Title
    Sponsor
    Name of the Sponsor
    University Hospital, Angers

    4. Oversight

    Studies a U.S. FDA-regulated Drug Product
    No
    Studies a U.S. FDA-regulated Device Product
    No
    Data Monitoring Committee
    Yes

    5. Study Description

    Brief Summary
    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.

    6. Conditions and Keywords

    Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
    Myocarditis Acute, Ventricular Arrythmia

    7. Study Design

    Primary Purpose
    Screening
    Study Phase
    Not Applicable
    Interventional Study Model
    Single Group Assignment
    Masking
    None (Open Label)
    Allocation
    N/A
    Enrollment
    50 (Anticipated)

    8. Arms, Groups, and Interventions

    Intervention Type
    Diagnostic Test
    Intervention Name(s)
    Treadmill Stress test
    Other Intervention Name(s)
    ECG Holter
    Intervention Description
    Ventricular arrhythmia will be assessed by ECG Holter and during treadmill stress test, both being performed 3 months and 1 year after acute myocarditis
    Primary Outcome Measure Information:
    Title
    Complex ventricular arrhythmia
    Description
    any ventricular tachycardia (triplet or more), ventricular fibrillation (observed on ECG Holter or during stress test)
    Time Frame
    any timepoint: 3 month and/or 1 year
    Secondary Outcome Measure Information:
    Title
    In-hospital ventricular arrhythmia
    Description
    any ventricular tachycardia (triplet or more), ventricular fibrillation, recorded on ECG monitoring
    Time Frame
    up to 2 weeks after admission
    Title
    Left Ventricular remodeling
    Description
    Change in LV volumes during time
    Time Frame
    between baseline and 3 months
    Title
    Left ventricular fibrosis
    Description
    Change in interstitial fibrosis by T1 mapping cardiac magnetic resonnance
    Time Frame
    between baseline and 3 months
    Title
    Major adverse cardio vascular event
    Description
    CV death, sudden cardiac death, cardiac graft or haemodynamic support, hospitalisation for heart failure, new event of myocarditis
    Time Frame
    up to 2 years after inclusion
    Title
    return to physical activity
    Description
    defined as at least 75% of exercising time (in hours per week)
    Time Frame
    up to 2 years after inclusion

    10. Eligibility

    Sex
    All
    Minimum Age & Unit of Time
    18 Years
    Accepts Healthy Volunteers
    No
    Eligibility Criteria
    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
    Central Contact Person:
    First Name & Middle Initial & Last Name or Official Title & Degree
    Loïc BIERE, MD PhD
    Phone
    +33 241354854
    Email
    lobiere@chu-angers.fr
    First Name & Middle Initial & Last Name or Official Title & Degree
    Fabrice PRUNIER, MD PhD
    Phone
    +33 241354858
    Overall Study Officials:
    First Name & Middle Initial & Last Name & Degree
    Loïc BIERE, MD PhD
    Organizational Affiliation
    Department of Cardiology, University Hospital of Angers (France)
    Official's Role
    Principal Investigator

    12. IPD Sharing Statement

    Plan to Share IPD
    Undecided
    Citations:
    PubMed Identifier
    28471960
    Citation
    Te ALD, Wu TC, Lin YJ, Chen YY, Chung FP, Chang SL, Lo LW, Hu YF, Tuan TC, Chao TF, Liao JN, Chien KL, Lin CY, Chang YT, Chen SA. Increased risk of ventricular tachycardia and cardiovascular death in patients with myocarditis during the long-term follow-up: A national representative cohort from the National Health Insurance Research Database. Medicine (Baltimore). 2017 May;96(18):e6633. doi: 10.1097/MD.0000000000006633.
    Results Reference
    background
    PubMed Identifier
    19221222
    Citation
    Maron BJ, Doerer JJ, Haas TS, Tierney DM, Mueller FO. Sudden deaths in young competitive athletes: analysis of 1866 deaths in the United States, 1980-2006. Circulation. 2009 Mar 3;119(8):1085-92. doi: 10.1161/CIRCULATIONAHA.108.804617. Epub 2009 Feb 16.
    Results Reference
    background
    PubMed Identifier
    26621644
    Citation
    Maron BJ, Udelson JE, Bonow RO, Nishimura RA, Ackerman MJ, Estes NA 3rd, Cooper LT Jr, Link MS, Maron MS; American Heart Association Electrocardiography and Arrhythmias Committee of Council on Clinical Cardiology, Council on Cardiovascular Disease in Young, Council on Cardiovascular and Stroke Nursing, Council on Functional Genomics and Translational Biology, and American College of Cardiology. Eligibility and Disqualification Recommendations for Competitive Athletes With Cardiovascular Abnormalities: Task Force 3: Hypertrophic Cardiomyopathy, Arrhythmogenic Right Ventricular Cardiomyopathy and Other Cardiomyopathies, and Myocarditis: A Scientific Statement From the American Heart Association and American College of Cardiology. Circulation. 2015 Dec 1;132(22):e273-80. doi: 10.1161/CIR.0000000000000239. Epub 2015 Nov 2. No abstract available.
    Results Reference
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    PubMed Identifier
    19389557
    Citation
    Friedrich MG, Sechtem U, Schulz-Menger J, Holmvang G, Alakija P, Cooper LT, White JA, Abdel-Aty H, Gutberlet M, Prasad S, Aletras A, Laissy JP, Paterson I, Filipchuk NG, Kumar A, Pauschinger M, Liu P; International Consensus Group on Cardiovascular Magnetic Resonance in Myocarditis. Cardiovascular magnetic resonance in myocarditis: A JACC White Paper. J Am Coll Cardiol. 2009 Apr 28;53(17):1475-87. doi: 10.1016/j.jacc.2009.02.007.
    Results Reference
    background
    PubMed Identifier
    23824828
    Citation
    Caforio AL, Pankuweit S, Arbustini E, Basso C, Gimeno-Blanes J, Felix SB, Fu M, Helio T, Heymans S, Jahns R, Klingel K, Linhart A, Maisch B, McKenna W, Mogensen J, Pinto YM, Ristic A, Schultheiss HP, Seggewiss H, Tavazzi L, Thiene G, Yilmaz A, Charron P, Elliott PM; European Society of Cardiology Working Group on Myocardial and Pericardial Diseases. Current state of knowledge on aetiology, diagnosis, management, and therapy of myocarditis: a position statement of the European Society of Cardiology Working Group on Myocardial and Pericardial Diseases. Eur Heart J. 2013 Sep;34(33):2636-48, 2648a-2648d. doi: 10.1093/eurheartj/eht210. Epub 2013 Jul 3.
    Results Reference
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