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Completed

NCT Number: NCT02177630

Magnetic Resonance Imaging in Myocarditis

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

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Key information

Conditions

Myocarditis Cardiomyopathies Cardiovascular Diseases Heart Diseases

Age range

18 year–80 year

Sex eligibility

All sexes

Study type

Observational

Primary location

Heart Center of the University Leipzig

Leipzig, 04289, Germany

About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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.

Treatment and study plan

Endomyocardial Biopsy

Other

Primary outcomes

  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 outcomes

  1. Diagnostic performance of biventricular endomyocardial biopsies

    Time frame: baseline

Sponsors and collaborators

Lead sponsor

Heart Center Leipzig - University Hospital

Other

Registry information

Official study title

Myocarditis and the Role of Advanced Magnetic Resonance Imaging

Acronym: MyoRacer

Important dates

Study start
2012
Primary completion
2015
Study completion
2015
First posted
Jun 27, 2014
Registry last updated
May 10, 2021

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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