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OpenTrials
Completed

NCT Number: NCT02299856

Cardiac Magnetic Resonance in Acute Myocarditis

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.

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Key information

Age range

16 year and older

Sex eligibility

All sexes

Study type

Observational

Primary location

University of Bonn, Dept. of Radiology

Bonn, North Rhine-Westphalia, 53127, Germany

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

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

Exclusion criteria

  • Contraindications for cardiac MR

Treatment and study plan

Cardiac magnetic resonance scan

Other

Primary outcomes

  1. 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].

  2. 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].

  3. 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.

  4. 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.

Sponsors and collaborators

Lead sponsor

University Hospital, Bonn

Other

Registry information

Important dates

Study start
2014
Primary completion
2015
Study completion
2015
First posted
Nov 24, 2014
Registry last updated
Dec 11, 2015

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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