Magnetic Resonance Imaging in Myocarditis

Myocarditis Clinical Trial

— MyoRacer  

Official title:

Myocarditis and the Role of Advanced Magnetic Resonance Imaging

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT02177630
• Other study ID #: 123456123456
• Status: Completed
• Start date: August 2012
• Est. completion date: December 2015

Study information

• Verified date: May 2021
• Source: Heart Center Leipzig - University Hospital
• Contact: n/a
• Is FDA regulated: No
• Study type: Observational

Clinical Trial 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

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 129
• Est. completion date: December 2015
• Est. primary completion date: December 2015
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years to 80 Years

Eligibility

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.

Related Conditions & MeSH terms

• Myocarditis

Intervention

Other:
• Endomyocardial Biopsy

Locations

Country	Name	City	State
Germany	Heart Center of the University Leipzig	Leipzig

Sponsors (1)

Lead Sponsor	Collaborator
Heart Center Leipzig - University Hospital

Country where clinical trial is conducted

Germany, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Accuracy, sensitivity and specificity of magnetic resonance imaging sequences	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	baseline
Secondary	Diagnostic performance of biventricular endomyocardial biopsies		baseline