International Myocarditis Registry (mmr)
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|ClinicalTrials.gov Identifier: NCT01307735|
Recruitment Status : Unknown
Verified February 2011 by Libin Cardiovascular Institute of Alberta.
Recruitment status was: Enrolling by invitation
First Posted : March 3, 2011
Last Update Posted : March 3, 2011
Myocarditis is an inflammatory heart disease primarily of viral origin that can lead to heart failure and death. Despite an unfavorable long-term outcome and mortality rate as high as 50%, classification, diagnosis, and treatment of myocarditis remains controversial. The gold standard for clinical diagnosis is direct sampling of the heart muscle, which often misses the infected area and thus reliability of the test is questionable. While the cause and clinical presentation of myocarditis are often unclear, inflammation of the heart muscle can be clearly imaged by Cardiovascular Magnetic Resonance Imaging (CMR).
Due to recent international consensus on CMR protocol for myocarditis and the unique ability of CMR to visualize cardiac structure, function, and characterize tissue, CMR has become the primary tool for clinical assessment. This study aims to test the accuracy of CMR in the diagnosis of myocarditis and to validate whether CMR acquired in an early stage of myocarditis can provide incremental prognostic information. In order to effectively gather relevant clinical data, an online, multi-centre international registry will be established across twenty different medical institutions.
- CMR accurately detects active myocardial inflammation in patients with myocarditis
- CMR acquired in an early clinical stage of myocarditis provides incremental prognostic information superior to standard clinical diagnostic tools.
|Condition or disease|
Show Detailed Description
|Study Type :||Observational|
|Estimated Enrollment :||78 participants|
|Observational Model:||Case Control|
|Official Title:||Prospective Assessment of the Clinical Utility of Cardiovascular Magnetic Resonance in Patients With Suspected Acute Myocarditis - A Pilot Study for Establishing an International Registry|
|Study Start Date :||January 2010|
|Estimated Primary Completion Date :||April 2011|
|Estimated Study Completion Date :||July 2011|
Myocarditis negative on CMR
Patients with suspected myocarditis referred for CMR and not fulfilling at least 2 of the 3 CMR criteria (Lake Louise Criteria)for myocarditis.Lake Louise Criteria are edema, hyperaemia, and necrosis/fibrosis.
Myocarditis positive on CMR
Patients with suspected myocarditis referred for CMR and fulfilling at least 2 of the 3 CMR criteria (Lake Louise Criteria)for myocarditis.Lake Louise Criteria are edema, hyperaemia, and necrosis/fibrosis.
To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT01307735
|Stephenson CMR Centre|
|Calgary, Alberta, Canada, T2N 2T9|
|Principal Investigator:||Matthias G Friedrich, MD||University of Calgary|