Cardiac Magnetic Resonance in Acute Myocarditis

Sponsor
University Hospital, Bonn (Other)
Overall Status
Completed
CT.gov ID
NCT02299856
Collaborator
(none)
84
1
18
4.7

Study Details

Study Description

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.

Condition or Disease Intervention/Treatment Phase
  • Other: Cardiac magnetic resonance scan

Study Design

Study Type:
Observational
Actual Enrollment :
84 participants
Observational Model:
Case-Control
Time Perspective:
Prospective
Official Title:
Cardiac Magnetic Resonance in Acute Myocarditis
Study Start Date :
Mar 1, 2014
Actual Primary Completion Date :
Mar 1, 2015
Actual Study Completion Date :
Sep 1, 2015

Arms and Interventions

Arm Intervention/Treatment
Myocarditis

Patients with strong clinical evidence for acute myocarditis (recent infection, elevated troponin and white blood cell count).

Other: Cardiac magnetic resonance scan

Healthy Controls

Healthy volunteers without any signs of cardiac disease.

Other: Cardiac magnetic resonance scan

Outcome Measures

Primary Outcome Measures

  1. 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].

  2. 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].

  3. 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.

  4. 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.

Eligibility Criteria

Criteria

Ages Eligible for Study:
16 Years and Older
Sexes Eligible for Study:
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

Contacts and Locations

Locations

Site City State Country Postal Code
1 University of Bonn, Dept. of Radiology Bonn NRW Germany 53127

Sponsors and Collaborators

  • University Hospital, Bonn

Investigators

None specified.

Study Documents (Full-Text)

None provided.

More Information

Publications

Responsible Party:
Claas P. Naehle, PD Dr. med., University Hospital, Bonn
ClinicalTrials.gov Identifier:
NCT02299856
Other Study ID Numbers:
  • 150/13.2
First Posted:
Nov 24, 2014
Last Update Posted:
Dec 11, 2015
Last Verified:
Dec 1, 2015
Keywords provided by Claas P. Naehle, PD Dr. med., University Hospital, Bonn
Additional relevant MeSH terms:

Study Results

No Results Posted as of Dec 11, 2015