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Recurrent Acute Myocarditis Registry (RAM)

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ClinicalTrials.gov Identifier: NCT04589156
Recruitment Status : Recruiting
First Posted : October 19, 2020
Last Update Posted : October 19, 2020
Sponsor:
Information provided by (Responsible Party):
University Hospital, Caen

Brief Summary:
The association between myocardial inflammation (clinically represented by acute myocarditis episodes) and the later development of an arrhythmogenic cardiomyopathy is widely elusive.

Condition or disease
Myocarditis Cardiomyopathy

Detailed Description:

Acute myocarditis (AM) is an inflammatory disease of the myocardium caused by different infectious and non-infectious triggers. It is a major cause of sudden cardiac death, with also long-term adverse outcomes in survivors. The incidence and predictive factors of recurrent AM (RAM) are unknown.

Arrhythmogenic cardiomyopathy (ACM) is a genetically-determined or acquired arrhythmogenic disorder of the myocardium. With an incidence of 1/5000, genetic ACM is the consequence of pathogenic variants in genes encoding for desmosomal and cytoskeleton proteins. Originally described as a right ventricular disease (ARVC), genetic ACM is increasingly recognized as a left (ALVC) or biventricular entity. Genetic ACM may manifest with various clinical presentations, with a predisposition to acute and chronic heart failure, ventricular arrhythmias and sudden cardiac death. Pathophysiology of genetic ACM at early stages remain widely elusive.

Myocardial inflammation has been consistently reported in patients with genetic ACM, but the exact nature of their association is a matter of debate. The temporal association between RAM episodes and the later diagnosis of genetic ACM is speculative, and it has been hypothesized recently that RAM episodes might reflect early active phases in the development of a genetic ACM.

The investigators aim to study the temporal association between RAM episodes and the later diagnosis of an ACM.

Consecutive patients with at least two episodes of AM and referred to a tertiary university referral center (pop. 1.500.000 inhabitants) for clinical expertise, follow-up and etiological work-out were prospectively included in this registry.

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Study Type : Observational [Patient Registry]
Estimated Enrollment : 20 participants
Observational Model: Cohort
Time Perspective: Cross-Sectional
Target Follow-Up Duration: 2 Years
Official Title: Recurrent Acute Myocarditis : Characteristics, Etiology, Prognosis and Genetic Basis.
Actual Study Start Date : January 1, 2018
Estimated Primary Completion Date : January 1, 2022
Estimated Study Completion Date : January 1, 2022

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Cardiomyopathy




Primary Outcome Measures :
  1. Sustained ventricular arrhythmia [ Time Frame: 0 - 1 year after last acute myocarditis episode ]

    Any ventricular arrhythmia (VT/VF) :

    • sustained (lasting more than 30 seconds)
    • symptomatic or not (including sudden cardiac arrest)
    • induced or not (including during stress ECG, pharmacological challenge or electrophysiological study)

  2. Genetic mutation [ Time Frame: 0 - 1 year after last acute myocarditis episode ]
    Any genetic mutation (cardiomyopathy panel)


Secondary Outcome Measures :
  1. Myocardial substrate characterization [ Time Frame: 0 - 1 year after last acute myocarditis episode ]
    Cardiac magnetic resonance imaging (left and right ventricular ejection fractions, volumes, late gadolinium enhancement)

  2. Nonsustained ventricular arrhythmia [ Time Frame: 0 - 1 year after last acute myocarditis episode ]

    Any ventricular arrhythmia (VT/VF) :

    • nonsustained (lasting less than 30 seconds)
    • symptomatic or not
    • induced or not (including during stress ECG, pharmacological challenge or electrophysiological study)



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Ages Eligible for Study:   Child, Adult, Older Adult
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Sampling Method:   Non-Probability Sample
Study Population
Patients with recurrent acute myocarditis.
Criteria
Inclusion Criteria: patients with at least two episodes of acute myocarditis as defined by the European Society of Cardiology diagnostic criteria.

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT04589156


Contacts
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Contact: Pierre Ollitrault, MD, MSc 0231064418 ollitrault-p@chu-caen.fr

Locations
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France
Caen University Hospital Recruiting
Caen, Normandy, France, F-14000
Contact: Pierre Ollitrault, MD, MSc    0231064418    ollitrault-p@chu-caen.fr   
Principal Investigator: Pierre Ollitrault, MD, MSc         
Principal Investigator: Fabien Labombarda, MD, PhD         
Sponsors and Collaborators
University Hospital, Caen
Publications:

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Responsible Party: University Hospital, Caen
ClinicalTrials.gov Identifier: NCT04589156    
Other Study ID Numbers: Rythmo20200818
First Posted: October 19, 2020    Key Record Dates
Last Update Posted: October 19, 2020
Last Verified: October 2020
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
Keywords provided by University Hospital, Caen:
Recurrent acute myocarditis
Myocardial inflammation
Arrhythmogenic cardiomyopathy
Additional relevant MeSH terms:
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Cardiomyopathies
Myocarditis
Heart Diseases
Cardiovascular Diseases