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Clinical Trials/NCT02177630
NCT02177630
Completed
Not Applicable

Myocarditis and the Role of Advanced Magnetic Resonance Imaging

Heart Center Leipzig - University Hospital1 site in 1 country129 target enrollmentAugust 2012
ConditionsMyocarditis

Overview

Phase
Not Applicable
Intervention
Not specified
Conditions
Myocarditis
Sponsor
Heart Center Leipzig - University Hospital
Enrollment
129
Locations
1
Primary Endpoint
Accuracy, sensitivity and specificity of magnetic resonance imaging sequences
Status
Completed
Last Updated
4 years ago

Overview

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.

Registry
clinicaltrials.gov
Start Date
August 2012
End Date
December 2015
Last Updated
4 years ago
Study Type
Observational
Sex
All

Investigators

Sponsor
Heart Center Leipzig - University Hospital
Responsible Party
Principal Investigator
Principal Investigator

Philipp Lurz

Clinical Investigator, Professor, Managing Senior Physician

Heart Center Leipzig - University Hospital

Eligibility Criteria

Inclusion Criteria

  • Symptoms such as:
  • Dyspnea or Orthopnea or
  • Palpitations or
  • Exercise intolerance or
  • 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.

Outcomes

Primary Outcomes

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 Outcomes

  • Diagnostic performance of biventricular endomyocardial biopsies(baseline)

Study Sites (1)

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