NCT02717143

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

• Status: Completed
• Phase: —
• Study type: Observational
• Enrollment: 821 (actual)
• Sponsor: French Cardiology Society · Academic / Other
• Sex: All
• Age: 18 Years
• Healthy volunteers: Not accepted

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.

Conditions

• Myocarditis
• Cardiomyopathy, Dilated
• Magnetic Resonance Imaging

Timeline

• Start date: 2016-04-01
• Primary completion: 2021-08-25
• Completion: 2021-12-31
• First posted: 2016-03-23
• Last updated: 2022-09-16

Locations

1 site across 1 country: France