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Clinical Trials/NCT02299856
NCT02299856CompletedNot Applicable

Cardiac Magnetic Resonance in Acute Myocarditis

University Hospital, Bonn1 site in 1 country84 target enrollmentStarted: March 2014Last updated:
Conditions

Trial Snapshot

Phase
Not Applicable
Status
Completed
Sponsor
Enrollment
84
Locations
1
Primary Endpoint
Myocardial T1 relaxation time

Study Overview

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.

Study Design

Study Type
Observational
Observational Model
Case Control
Time Perspective
Prospective

Eligibility Criteria

Ages
16 Years to — (Child, Adult, Older Adult)
Sex
All
Accepts Healthy Volunteers
Yes

Inclusion Criteria

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

Exclusion Criteria

  • Contraindications for cardiac MR

Outcomes

Primary Outcomes

Myocardial T1 relaxation time

Time Frame: 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

Time Frame: 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

Time Frame: 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)

Time Frame: 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.

Secondary Outcomes

No secondary outcomes reported

Investigators

Sponsor
University Hospital, Bonn
Sponsor Class
Other
Responsible Party
Principal Investigator
Principal Investigator

Claas P. Naehle

PD Dr. med.

University Hospital, Bonn

Study Sites (1)

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