Magnetic Resonance Imaging in Myocarditis

Completed

• Conditions: Myocarditis
• Interventions: Other: Endomyocardial Biopsy

• Registration Number: NCT02177630
• Lead Sponsor: Heart Center Leipzig - University Hospital

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.

Study Timeline

• Study Start: 2012-08
• Study First Submitted: 2014-06-22
• Study First Submitted QC: 2014-06-25
• Study First Posted: 2014-06-27
• Primary Completion: 2015-12
• Study Completion: 2015-12
• Status Verified: 2021-05
• Last Update Submitted: 2021-05-06
• Last Update Posted: 2021-05-10

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 129

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.

Study & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Arm && Interventions

Group	Intervention	Description
Magnetic resonance imaging and endomyocardial biopsy	Endomyocardial Biopsy	Magnetic resonance imaging and endomyocardial biopsy

Primary Outcome Measures

Name	Time	Method
Accuracy, sensitivity and specificity of magnetic resonance imaging sequences	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

Name	Time	Method
Diagnostic performance of biventricular endomyocardial biopsies	baseline

Trial Locations

Locations (1)

Heart Center of the University Leipzig; 🇩🇪 Leipzig, Germany