Clinical trial NCT02177630: Magnetic Resonance Imaging in Myocarditis
Official title: Myocarditis and the Role of Advanced Magnetic Resonance Imaging
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Myocarditis
Keywords: myocarditis, myocardial inflammation, imaging, magnetic resonance
Lead sponsor: Heart Center Leipzig - University Hospital
Sponsor class: OTHER
First posted: 2014-06-27
Enrollment: 129
Sex: ALL
Minimum age (years): 18
Maximum age (years): 80
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: COHORT
Time perspective: PROSPECTIVE
Sampling method: PROBABILITY_SAMPLE
Study population: Patients with clinical suspicion of myocarditis

Brief summary: The purpose of this study is the assess the diagnostic performance of magnetic resonance imaging in patients with suspected myocarditis by applying different imaging sequences at different MR scanners

Detailed description: In patients with clinical suspicion of myocarditis biventricular endomyocardial biopsy is performed for definite diagnosis. In addition, patients undergo magnetic resonance imaging at 1.5 Tesla and 3.0 Tesla within 24 hours. The imaging protocol of both scan include assessment of myocardial edema respectively edema ratio; myocardial hyperemia respectively global relative enhancement (gRE); myocardial fibrosis/necrosis respectively myocardial LE and T1 and T2 mapping sentences. Diagnostic performance of different imaging protocols as compared to the findings of endomyocardial biopsies is calculated.

The protocol also includes a follow-up MR can at 3 months.

Eligibility criteria: Inclusion Criteria:

Symptoms such as:

* Dyspnea or Orthopnea or
* Palpitations or
* Exercise intolerance or
* Angina

Evidence of myocardial involvement:

* ventricular dysfunction on echocardiography or
* new or persistent ECG changes
* elevated Troponin T History of viral infection

Exclusion Criteria:

* Contraindication for magnetic resonance imaging
* Impaired renal function: glomerular filtration rate ≤ 30 ml/min/m2
* Patients presenting with pregnancy
* Patients without informed consent
* Participation in another trial.

Primary outcomes:
measure: Accuracy, sensitivity and specificity of magnetic resonance imaging sequences
timeFrame: baseline
Secondary outcomes:
measure: Diagnostic performance of biventricular endomyocardial biopsies
timeFrame: baseline
Other outcomes:
Locations:
city: Leipzig
country: Germany
facility: Heart Center of the University Leipzig
Study officials:
affiliation: Heart Center of the University of Leipzig
name: Philipp Lurz, MD, PhD
role: PRINCIPAL_INVESTIGATOR
References:
citation: Baessler B, Luecke C, Lurz J, Klingel K, Das A, von Roeder M, de Waha-Thiele S, Besler C, Rommel KP, Maintz D, Gutberlet M, Thiele H, Lurz P. Cardiac MRI and Texture Analysis of Myocardial T1 and T2 Maps in Myocarditis with Acute versus Chronic Symptoms of Heart Failure. Radiology. 2019 Sep;292(3):608-617. doi: 10.1148/radiol.2019190101. Epub 2019 Jul 30.
citation: Lurz P, Luecke C, Eitel I, Fohrenbach F, Frank C, Grothoff M, de Waha S, Rommel KP, Lurz JA, Klingel K, Kandolf R, Schuler G, Thiele H, Gutberlet M. Comprehensive Cardiac Magnetic Resonance Imaging in Patients With Suspected Myocarditis: The MyoRacer-Trial. J Am Coll Cardiol. 2016 Apr 19;67(15):1800-1811. doi: 10.1016/j.jacc.2016.02.013.