Myocarditis Clinical Trial
Official title:
Cardiac Magnetic Resonance in Acute Myocarditis
Verified date | December 2015 |
Source | University Hospital, Bonn |
Contact | n/a |
Is FDA regulated | No |
Health authority | Germany: Ethics Commission |
Study type | Observational |
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.
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 |
Observational Model: Case Control, Time Perspective: Prospective
Country | Name | City | State |
---|---|---|---|
Germany | University of Bonn, Dept. of Radiology | Bonn | NRW |
Lead Sponsor | Collaborator |
---|---|
University Hospital, Bonn |
Germany,
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
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 |
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