Recurrent Acute Myocarditis Registry (RAM)

October 14, 2020 updated by: University Hospital, Caen

Recurrent Acute Myocarditis : Characteristics, Etiology, Prognosis and Genetic Basis.

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

Study Overview

Status

Unknown

Conditions

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.

Study Type

Observational

Enrollment (Anticipated)

20

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • France
    • Normandy
      • Caen, Normandy, France, F-14000
        • Recruiting
        • CAEN University Hospital
        • Contact:
        • Principal Investigator:
          • Pierre Ollitrault, MD, MSc
        • Principal Investigator:
          • Fabien Labombarda, MD, PhD

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

  • Child
  • Adult
  • Older Adult

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Sampling Method

Non-Probability Sample

Study Population

Patients with recurrent acute myocarditis.

Description

Inclusion Criteria: patients with at least two episodes of acute myocarditis as defined by the European Society of Cardiology diagnostic criteria.

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Observational Models: Cohort
  • Time Perspectives: Cross-Sectional

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
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)
0 - 1 year after last acute myocarditis episode
Genetic mutation
Time Frame: 0 - 1 year after last acute myocarditis episode
Any genetic mutation (cardiomyopathy panel)
0 - 1 year after last acute myocarditis episode

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
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)
0 - 1 year after last acute myocarditis episode
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)
0 - 1 year after last acute myocarditis episode

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

University Hospital, Caen

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

January 1, 2018

Primary Completion (Anticipated)

January 1, 2022

Study Completion (Anticipated)

January 1, 2022

Study Registration Dates

First Submitted

August 31, 2020

First Submitted That Met QC Criteria

October 14, 2020

First Posted (Actual)

October 19, 2020

Study Record Updates

Last Update Posted (Actual)

October 19, 2020

Last Update Submitted That Met QC Criteria

October 14, 2020

Last Verified

October 1, 2020

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • Rythmo20200818

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

No

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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