Magnetic Resonance Imaging in Myocarditis

NCT ID: NCT02177630

Last Updated: 2021-05-10

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Total Enrollment

129 participants

Study Classification

OBSERVATIONAL

Study Start Date

2012-08-31

Study Completion Date

2015-12-31

Brief Summary

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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

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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.

Conditions

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Myocarditis

Study Design

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Observational Model Type

COHORT

Study Time Perspective

PROSPECTIVE

Study Groups

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Magnetic resonance imaging and endomyocardial biopsy

Magnetic resonance imaging and endomyocardial biopsy

Endomyocardial Biopsy

Intervention Type OTHER

Interventions

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Endomyocardial Biopsy

Intervention Type OTHER

Eligibility Criteria

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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.
Minimum Eligible Age

18 Years

Maximum Eligible Age

80 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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Heart Center Leipzig - University Hospital

OTHER

Sponsor Role lead

Responsible Party

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Philipp Lurz

Clinical Investigator, Professor, Managing Senior Physician

Responsibility Role PRINCIPAL_INVESTIGATOR

Principal Investigators

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Philipp Lurz, MD, PhD

Role: PRINCIPAL_INVESTIGATOR

Heart Center of the University of Leipzig

Locations

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Heart Center of the University Leipzig

Leipzig, , Germany

Site Status

Countries

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Germany

References

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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.

Reference Type DERIVED
PMID: 31361205 (View on PubMed)

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.

Reference Type DERIVED
PMID: 27081020 (View on PubMed)

Other Identifiers

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123456123456

Identifier Type: -

Identifier Source: org_study_id

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