Cardiac Magnetic Resonance in Acute Myocarditis

Myocarditis Clinical Trial

Official title:

Cardiac Magnetic Resonance in Acute Myocarditis

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT02299856
• Other study ID #: 150/13.2
• Status: Completed
• Phase: N/A
• First received: November 13, 2014
• Last updated: December 9, 2015
• Start date: March 2014
• Est. completion date: September 2015

Study information

• Verified date: December 2015
• Source: University Hospital, Bonn
• Contact: n/a
• Is FDA regulated: No
• Health authority: Germany: Ethics Commission
• Study type: Observational

Clinical Trial 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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 84
• Est. completion date: September 2015
• Est. primary completion date: March 2015
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: Both
• Age group: 16 Years and older

Eligibility

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

Observational Model: Case Control, Time Perspective: Prospective

Related Conditions & MeSH terms

• Myocarditis

Intervention

Other:
• Cardiac magnetic resonance scan

Locations

Country	Name	City	State
Germany	University of Bonn, Dept. of Radiology	Bonn	NRW

Sponsors (1)

Lead Sponsor	Collaborator
University Hospital, Bonn

Country where clinical trial is conducted

Germany, 

References & Publications (1)

Luetkens JA, Doerner J, Thomas DK, Dabir D, Gieseke J, Sprinkart AM, Fimmers R, Stehning C, Homsi R, Schwab JO, Schild H, Naehle CP. Acute myocarditis: multiparametric cardiac MR imaging. Radiology. 2014 Nov;273(2):383-92. doi: 10.1148/radiol.14132540. Epub 2014 Jun 6. — View Citation

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Myocardial T1 relaxation time	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].	Measurement will be performed within 2 weeks after MRI scan.	No
Primary	Myocardial T2 relaxation time	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].	Measurement will be performed within 2 weeks after MRI scan.	No
Primary	Myocardial ECV measurements	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.	Measurement will be performed within 2 weeks after MRI scan.	No
Primary	Myocardial strain analysis (focussed on longitudinal strain)	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.	Measurement will be performed within 2 weeks after MRI scan.	No