French National Observatory Tracking Viral Myocarditis: Mortality, Cardiovascular Events, Sequels on (Magnetic Resonance Imaging) MRI (MYOCARDITIRM)

September 15, 2022 updated by: French Cardiology Society

Acute myocarditis is a serious illness affecting a young population with a very variable course (of full recovery at the onset of dilated cardiomyopathy (DCM), or even sudden death). Very few studies have examined the predictors of death and serious cardiovascular events in acute myocarditis and have carried on numbers of restricted patients. What little data results in a lack of a precise recommendation on the management and the follow-up period of patients.

This observational study should identify serious prognostic factor for cardiovascular events in order to provide a support strategy and more appropriate monitoring of myocarditis.

Study Overview

Status

Completed

Conditions

Detailed Description

Patients included in the study benefit from clinical monitoring, ultrasound and MRI as planned according to the habits of the center, regardless of the study. These clinical monitoring data, ultrasound and MRI will be collected as part of the study and if necessary telephone follow-up of cardiologists contractors will be made to complete the data. No additional examination will be conducted as part of this study. The data collected especially for cardiac MRI, will be based on the current monitoring protocol in each center.

All patients included in this study have received information and signed a consent to the use of their data during hospitalization and follow-up.

As part of this study, the inclusions are planned for a period of 2 years or more to reach a recruitment of 700 patients. The tracking target is 3 years, with an annual follow-up.

Patient follow-up is made by the doctor who selected the patient. Clinical follow-up will be made at a consultation normally provided for in hospital or cardiology practice in this type of pathology.

Study Type

Observational

Enrollment (Actual)

821

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

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

18 years and older (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Sampling Method

Non-Probability Sample

Study Population

All consecutive patients with clinical features of acute myocarditis previously defined and who underwent cardiac MRI which concluded the diagnosis of acute myocarditis, having agreed to participate in the study and admitted in one of the participating centers.

Description

Inclusion Criteria:

  • Patient aged 18 years and over

  • Hospitalized suspect table of acute myocarditis: Eligible patients must have an increase of troponin I greater than the threshold value of the pathological laboratory of Biochemistry, associated with at least one of the three following criteria:

    1. prolonged chest pain> 10 minutes,
    2. recent infectious context <7 days
    3. subject young and / or absence of cardiovascular risk factors and / or absence of significant coronary lesions in coronary angiography if the patient had a coronary angiography.
  • Having received a cardiac MRI which concluded the diagnosis of acute myocarditis according to the usual criteria of the center (Lake Louise criteria changed according to the habits of the center) There myocarditis when at least two of the following criteria are met: hyperintense T2; hyperintense Diffusion; myocardium ratio signal / peripheral muscle Gadolinium> 4; contrast enhancement after injection of gadolinium chelate in cine-steady-state free precession (SSFP); nonischemic type of signal on delayed enhancement. These anomalies are segmental topography typically subepicardial. The analysis is made of the 17 segments of the left ventricle.
  • Patient was informed and has given its consent for the study

Exclusion Criteria:

  • Refusal of consent
  • Claustrophobia

  • Formal contraindications to MRI (allergic reaction to gadolinium chelates, porters pregnancy or patients against-indicated materials listed on the site MRI Safety "www.MRIsafety.com") :

    • Incompatible heart Pacemaker and Defibrillator
    • heart valve prostheses: valves Starr
    • Metal splinters
    • Coils intra cranial, intra cerebral surgical clips, bypass valves
    • Neurological stimulators
    • Insulin Pumps
    • Orthopedic Materials: cervical fixation with cervical Halo vest or fixer
    • Body piercing not be withdrawn

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

Cohorts and Interventions

Group / Cohort
Acute myocarditis

Patients with a clinical picture suggestive of acute myocarditis: increase of troponin above the threshold defined by the pathological laboratory, associated with at least one of the three following criteria:

  1. prolonged chest pain > 10 minutes,
  2. recent infectious context <7 days
  3. young subject and / or absence of cardiovascular risk factors and / or absence of significant coronary lesion

Patients will be included after completion of MRI confirm the diagnosis. They will be followed for 3 years, every year, by the doctor who included them in the study.

This is an observational study that does not affect the management of patients.

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Time Frame
All cause mortality at 1 year of follow-up
Time Frame: 1 year
1 year
Cardiovascular mortality at 1 year of follow-up
Time Frame: 1 year
1 year

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
All cause mortality at 3 years of follow-up
Time Frame: 3 years
3 years
Incidence of cardiovascular events at 3 years of follow-up
Time Frame: 3 years
Incidence of heart failure requiring hospitalization, diagnostic of DCM not posed before the episode of myocarditis, stroke, heart transplant
3 years
Incidence of sequelae of myocarditis in cardiac MRI for patients undergoing cardiac MRI in their monitoring at 3 years of follow-up
Time Frame: 3 years
3 years

Collaborators and Investigators

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

Sponsor

French Cardiology Society

Investigators

  • Principal Investigator: Phalla OU, MD. PhD, Assistance Publique - Hôpitaux de Paris
  • Principal Investigator: Claire BOULETI, Assistance Publique - Hôpitaux de Paris

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)

April 1, 2016

Primary Completion (Actual)

August 25, 2021

Study Completion (Actual)

December 31, 2021

Study Registration Dates

First Submitted

March 18, 2016

First Submitted That Met QC Criteria

March 18, 2016

First Posted (Estimate)

March 23, 2016

Study Record Updates

Last Update Posted (Actual)

September 16, 2022

Last Update Submitted That Met QC Criteria

September 15, 2022

Last Verified

September 1, 2022

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • 15677

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

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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