CMR in Patients With Myocarditis

Completed

• Conditions: Suspected Acute Myocarditis

• Registration Number: NCT01962584
• Lead Sponsor: University Hospital, Bonn

Brief Summary

To evaluate the additive values of T1 mapping in patients with acute myocarditis.

Detailed Description

Cardiac magnetic resonance (CMR) is an established non-invasive diagnostic tool for acute and chronic myocarditis. Established CMR criteria for diagnosing myocarditis are edema on black-blood T2-weighted imaging, relative contrast enhancement seen on T1-weighted imaging for assessment of hyperemia, and late contrast-agent enhancement seen with inversion recovery late enhancement technique for visualization of myocardial fibrosis.

Recently, tissue characterization based on calculation of myocardial T1 relaxation time (T1 mapping) as well as T1-derived extracellular volume fraction has become available. Recently, reference values for myocardial T1 relaxation times at 3T for healthy volunteers were published for CMR. However, to date no comprehensive data for multiparametric CMR in patients with suspected myocarditis at 3 Tesla is available. Therefore, the purpose of this prospective study was to evaluate the diagnostic value of CMR at 3T in patients with suspected acute myocarditis using a multiparametric CMR approach including T1 mapping as novel tool for tissue characterization.

CMR will be performed within 7 days after hospital admission for "suspected acute myocarditis".

Study Timeline

• Study Start: 2013-09
• Study First Submitted: 2013-10-04
• Study First Submitted QC: 2013-10-09
• Study First Posted: 2013-10-14
• Primary Completion: 2014-10
• Study Completion: 2014-10
• Status Verified: 2015-12
• Last Update Submitted: 2015-12-09
• Last Update Posted: 2015-12-11

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 66

Inclusion Criteria

• patients with suspected acute myocarditis and otherwise unremarkable cardiac history

Exclusion Criteria

• exclusion of CAD in invasive coronary angiography
• pregnancy
• contraindications for MR imaging

Study & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
T1 relaxation times	time of CMR, CMR will be performed within 7 days after hospital admission for "suspected acute myocardtitis".	quantification of T1 relaxation times

Secondary Outcome Measures

Name	Time	Method
Extracellular volume (ECV)	time of CMR, CMR will be performed within 7 days after hospital admission for "suspected acute myocardtitis".	calculation of extracellular volume based on T1 relaxation time

Trial Locations

Locations (1)

University of Bonn; 🇩🇪 Bonn, NRW, Germany