Cardiac Magnetic Resonance in Acute Myocarditis

NCT02299856 | Completed

• 1 other identifier: 150/13.2
• Study Type: observational
• Target: 84
• Locations: 1 country
• Sites: 1

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.

Conditions

Myocarditis

Keywords

Magnetic Resonance Imaging; Diagnostic Imaging

Outcome Measures

Primary Outcomes (4)

• 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.

• 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.

• 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.

• 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.

Study Arms (2)

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

Interventions

Cardiac magnetic resonance scan OTHER

Healthy Controls; Myocarditis

Eligibility Criteria

• Age: 16 Years+
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Child (0-17), Adult (18-64), Older Adult (65+)
• Sampling Method: Probability Sample

Study Population

Patients are included in the myocarditis group if they showed clinical evidence of acute myocarditis(acute chest pain, history of viral infection, elevated white blood cell count, ECG changes and/or elevated troponin).

You may qualify if:

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

You may not qualify if:

• Contraindications for cardiac MR

Sponsors & Collaborators

• University Hospital, Bonn: lead

Study Sites (1)

University of Bonn, Dept. of Radiology

Bonn, North Rhine-Westphalia, 53127, Germany

Location

Related Publications (2)

• 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.

  PMID: 24910904 BACKGROUND

• Luetkens JA, Homsi R, Sprinkart AM, Doerner J, Dabir D, Kuetting DL, Block W, Andrie R, Stehning C, Fimmers R, Gieseke J, Thomas DK, Schild HH, Naehle CP. Incremental value of quantitative CMR including parametric mapping for the diagnosis of acute myocarditis. Eur Heart J Cardiovasc Imaging. 2016 Feb;17(2):154-61. doi: 10.1093/ehjci/jev246. Epub 2015 Oct 16.

  PMID: 26476398 DERIVED

Biospecimen

Retention: SAMPLES WITH DNA

Hematocrit is obtained prior to cardiac MR.

MeSH Terms

Conditions

Myocarditis

Condition Hierarchy (Ancestors)

Cardiomyopathies; Heart Diseases; Cardiovascular Diseases

Study Design

• Study Type: observational
• Observational Model: CASE CONTROL
• Time Perspective: PROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: PD Dr. med.

Study Record Dates

• First Submitted: November 13, 2014
• First Posted: November 24, 2014
• Study Start: March 1, 2014
• Primary Completion: March 1, 2015
• Study Completion: September 1, 2015
• Last Updated: December 11, 2015

Record last verified: 2015-12

Locations

DE (1)