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
About this trial
This is an interventional screening trial for Myocarditis Acute
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
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
NCT ID
NCT03842592
First Posted
January 28, 2019
Last Updated
February 12, 2019
Sponsor
University Hospital, Angers
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
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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
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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
background
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
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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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Ventricular Arrhythmia After Myocarditis in Sportsman
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