Overview

This trial is active, not recruiting.

Condition myocarditis
Treatment endomyocardial biopsy
Sponsor University of Leipzig
Start date August 2012
End date December 2015
Trial size 120 participants
Trial identifier NCT02177630, 123456123456

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

United States No locations recruiting
Other Countries No locations recruiting

Study Design

Observational model cohort
Time perspective prospective
Arm
Magnetic resonance imaging and endomyocardial biopsy
endomyocardial biopsy

Primary Outcomes

Measure
Accuracy, sensitivity and specificity of magnetic resonance imaging sequences
time frame: baseline

Secondary Outcomes

Measure
Diagnostic performance of biventricular endomyocardial biopsies
time frame: baseline

Eligibility Criteria

Male or female participants from 18 years up to 80 years old.

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.

Additional Information

Official title Myocarditis and the Role of Advanced Magnetic Resonance Imaging
Principal investigator Philipp Lurz, MD, PhD
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.
Trial information was received from ClinicalTrials.gov and was last updated in November 2015.
Information provided to ClinicalTrials.gov by University of Leipzig.