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

Completed

• Conditions: Magnetic Resonance Imaging; Myocarditis; Cardiomyopathy, Dilated

• Registration Number: NCT02717143
• Lead Sponsor: French Cardiology Society

Brief Summary

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.

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 Timeline

• Study First Submitted: 2016-03-18
• Study First Submitted QC: 2016-03-18
• Study First Posted: 2016-03-23
• Study Start: 2016-04
• Primary Completion: 2021-08-25
• Study Completion: 2021-12-31
• Status Verified: 2022-09
• Last Update Submitted: 2022-09-15
• Last Update Posted: 2022-09-16

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 821

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 & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
Cardiovascular mortality at 1 year of follow-up	1 year
All cause mortality at 1 year of follow-up	1 year

Secondary Outcome Measures

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

Trial Locations

Locations (1)

Bichat; 🇫🇷 Paris, France