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Magnetic Resonance Imaging in Myocarditis (MyoRacer)

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT02177630
Recruitment Status : Completed
First Posted : June 27, 2014
Last Update Posted : May 10, 2021
Sponsor:
Information provided by (Responsible Party):
Philipp Lurz, Heart Center Leipzig - University Hospital

Study Description
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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

Condition or disease Intervention/treatment
Myocarditis Other: Endomyocardial Biopsy

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.

Study Design
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Study Type : Observational
Actual Enrollment : 129 participants
Observational Model: Cohort
Time Perspective: Prospective
Official Title: Myocarditis and the Role of Advanced Magnetic Resonance Imaging
Study Start Date : August 2012
Actual Primary Completion Date : December 2015
Actual Study Completion Date : December 2015

Resource links provided by the National Library of Medicine


Groups and Cohorts
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Group/Cohort Intervention/treatment
Magnetic resonance imaging and endomyocardial biopsy
Magnetic resonance imaging and endomyocardial biopsy
 Other: Endomyocardial Biopsy


Outcome Measures
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Primary Outcome Measures :
  1. Accuracy, sensitivity and specificity of magnetic resonance imaging sequences [ Time Frame: baseline ]
    The diagnostic accuracy of individual and a combination of MR imaging sequences (late enhancement images, assessment of global edema, relative enhancement and T1 and T2 mapping sequences) will be determined by comparison to endomyocardial biopsies, which serve as diagnostic gold-standard


Secondary Outcome Measures :
  1. Diagnostic performance of biventricular endomyocardial biopsies [ Time Frame: baseline ]

Eligibility Criteria
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Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years to 80 Years   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Sampling Method:   Probability Sample
Study Population
Patients with clinical suspicion of myocarditis
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.
Contacts and Locations
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Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT02177630


Locations
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Germany
Heart Center of the University Leipzig
Leipzig, Germany, 04289
Sponsors and Collaborators
Heart Center Leipzig - University Hospital
Investigators
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Principal Investigator: Philipp Lurz, MD, PhD Heart Center of the University of Leipzig
More Information
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Publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):

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Responsible Party: Philipp Lurz, Clinical Investigator, Professor, Managing Senior Physician, Heart Center Leipzig - University Hospital
ClinicalTrials.gov Identifier: NCT02177630    
Other Study ID Numbers: 123456123456
First Posted: June 27, 2014    Key Record Dates
Last Update Posted: May 10, 2021
Last Verified: May 2021
Keywords provided by Philipp Lurz, Heart Center Leipzig - University Hospital:
myocarditis, myocardial inflammation, imaging, magnetic resonance
Additional relevant MeSH terms:
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Myocarditis
Cardiomyopathies
Heart Diseases
Cardiovascular Diseases