Cardiac Magnetic Resonance in Acute Myocarditis

Completed

• Conditions: Myocarditis
• Interventions: Other: Cardiac magnetic resonance scan

• Registration Number: NCT02299856
• Lead Sponsor: University Hospital, Bonn

Brief Summary

Cardiac magnetic resonance (MR) is an established noninvasive diagnostic tool for detection of acute myocarditis. Diagnosis of myocarditis at 1.5T is currently made with the help of the Lake Louise Criteria (two of three criteria have to be positive in order to establish the diagnosis). Although these criteria are accepted and widely used in clinical routine, several disadvantages exist. Newer parameters like myocardial T1 and T2 mapping, extracellular volume fraction (ECV) and myocardial strain analysis have the potential to complement or even replace some of the Lake Louise Criteria and further enhance the diagnostic performance of cardiac MR in patients suspected of having acute myocarditis. The aim of our study is to evaluate the diagnostic performance of a comprehensive cardiac MR protocol in patients with acute myocarditis.

Detailed Description

Not available

Study Timeline

• Study Start: 2014-03
• Study First Submitted: 2014-11-13
• Study First Submitted QC: 2014-11-20
• Study First Posted: 2014-11-24
• Primary Completion: 2015-03
• Study Completion: 2015-09
• Status Verified: 2015-12
• Last Update Submitted: 2015-12-09
• Last Update Posted: 2015-12-11

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 84

Inclusion Criteria

• No past medical history of cardiac disease.
• No cardiovascular risk factors (e.g. diabetes or hypertension)

Exclusion Criteria

• Contraindications for cardiac MR

Study & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Arm && Interventions

Group	Intervention	Description
Healthy Controls	Cardiac magnetic resonance scan	Healthy volunteers without any signs of cardiac disease.
Myocarditis	Cardiac magnetic resonance scan	Patients with strong clinical evidence for acute myocarditis (recent infection, elevated troponin and white blood cell count).

Primary Outcome Measures

Name	Time	Method
Myocardial T1 relaxation time	Measurement will be performed within 2 weeks after MRI scan.	Changes in myocardial T1 relaxation time is of interest in patients with acute myocarditis. T1 relaxation times will be directly obtained from the T1 maps through ROI analysis. T1 maps will be analyzed using a segmental approach. T1 relaxation times are given in \[ms\].
Myocardial T2 relaxation time	Measurement will be performed within 2 weeks after MRI scan.	Changes in myocardial T2 relaxation time is of interest in patients with acute myocarditis. T2 relaxation times will be directly obtained from T2 maps through ROI analysis. T2 maps will be analyzed using a segmental approach. T2 relaxation times are given in \[ms\].
Myocardial ECV measurements	Measurement will be performed within 2 weeks after MRI scan.	Changes in myocardial ECV parameters is of interest in patients with acute myocarditis. Hematocrit corrected ECV will be calculated using pre- and post-contrast T1 values for myocardium and blood pool using following formula: ECV= (1⁄T1 "myocardium post contrast"-1⁄T1 "myocadium pre contrast")/(1⁄T1 "blood post contrast"-1⁄ T1 "blood pre contrast") x (1-hematocrit).; ECV is given in percentage.
Myocardial strain analysis (focussed on longitudinal strain)	Measurement will be performed within 2 weeks after MRI scan.	Changes in longitudinal strain as determined by echocardiography has been described in patient with acute myocarditis. In our study longitudinal strain is measured using feature tracking, which allows for strain calculation from standard MR cine datasets.

Trial Locations

Locations (1)

University of Bonn, Dept. of Radiology; 🇩🇪 Bonn, NRW, Germany