Clinical Trial: Magnetic Resonance Imaging in Myocarditis

Study Status: Active, not recruiting
Recruit Status: Active, not recruiting
Study Type: Observational

Official Title: Myocarditis and the Role of Advanced Magnetic Resonance Imaging

Brief Summary: The purpose of this study is the assess the diagnostic performance of magnetic resonance imaging in patients with suspected myocarditis by applying different imaging sequences at different MR scanners

Detailed Summary:

In patients with clinical suspicion of myocarditis biventricular endomyocardial biopsy is performed for definite diagnosis. In addition, patients undergo magnetic resonance imaging at 1.5 Tesla and 3.0 Tesla within 24 hours. The imaging protocol of both scan include assessment of myocardial edema respectively edema ratio; myocardial hyperemia respectively global relative enhancement (gRE); myocardial fibrosis/necrosis respectively myocardial LE and T1 and T2 mapping sentences. Diagnostic performance of different imaging protocols as compared to the findings of endomyocardial biopsies is calculated.

The protocol also includes a follow-up MR can at 3 months.


Sponsor: University of Leipzig

Current Primary Outcome: Accuracy, sensitivity and specificity of magnetic resonance imaging sequences [ Time Frame: baseline ]

The diagnostic accuracy of individual and a combination of MR imaging sequences (late enhancement images, assessment of global edema, relative enhancement and T1 and T2 mapping sequences) will be determined by comparison to endomyocardial biopsies, which serve as diagnostic gold-standard


Original Primary Outcome: Same as current

Current Secondary Outcome: Diagnostic performance of biventricular endomyocardial biopsies [ Time Frame: baseline ]

Original Secondary Outcome: Same as current

Information By: University of Leipzig

Dates:
Date Received: June 22, 2014
Date Started: August 2012
Date Completion: December 2015
Last Updated: November 30, 2015
Last Verified: November 2015