MyoRacer: Magnetic Resonance Imaging in Myocarditis

• Sponsor: Heart Center Leipzig - University Hospital (Other)
• Overall Status: Completed
• CT.gov ID: NCT02177630
• Collaborator: (none)
• Enrollment: 129
• Location: 1
• Duration (Months): 40
• Patients Per Site Per Month: 3.2

Study Details

Study Description

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

Condition or Disease	Intervention/Treatment	Phase
Myocarditis	Other: Endomyocardial Biopsy

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 Design

• Study Type: Observational
• Actual Enrollment: 129 participants
• Observational Model: Cohort
• Time Perspective: Prospective
• Official Title: Myocarditis and the Role of Advanced Magnetic Resonance Imaging
• Study Start Date: Aug 1, 2012
• Actual Primary Completion Date: Dec 1, 2015
• Actual Study Completion Date: Dec 1, 2015

Arms and Interventions

Arm	Intervention/Treatment
Magnetic resonance imaging and endomyocardial biopsy Magnetic resonance imaging and endomyocardial biopsy	Other: Endomyocardial Biopsy

Outcome Measures

Primary Outcome Measures

1. 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

1. Diagnostic performance of biventricular endomyocardial biopsies [baseline]

Eligibility Criteria

Criteria

• Ages Eligible for Study: 18 Years to 80 Years
• Sexes Eligible for Study: All
• Accepts Healthy Volunteers: No

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.

Contacts and Locations

Locations

	Site	City	State	Country	Postal Code
1	Heart Center of the University Leipzig	Leipzig		Germany	04289

Sponsors and Collaborators

• Heart Center Leipzig - University Hospital

Investigators

• Principal Investigator: Philipp Lurz, MD, PhD, Heart Center of the University of Leipzig

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.

• Responsible Party: Philipp Lurz, Clinical Investigator, Professor, Managing Senior Physician, Heart Center Leipzig - University Hospital
• ClinicalTrials.gov Identifier: NCT02177630
• Other Study ID Numbers: 123456123456
• First Posted: Jun 27, 2014
• Last Update Posted: May 10, 2021
• Last Verified: May 1, 2021

• Keywords provided by Philipp Lurz, Clinical Investigator, Professor, Managing Senior Physician, Heart Center Leipzig - University Hospital: myocarditis, myocardial inflammation, imaging, magnetic resonance
• Additional relevant MeSH terms: Myocarditis

Study Results

No Results Posted as of May 10, 2021