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International Myocarditis Registry (mmr)

This study is enrolling participants by invitation only.
Sponsor:
Information provided by:
Libin Cardiovascular Institute of Alberta
ClinicalTrials.gov Identifier:
NCT01307735
First received: March 2, 2011
Last updated: NA
Last verified: February 2011
History: No changes posted
  Purpose

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.

Hypotheses:

  1. CMR accurately detects active myocardial inflammation in patients with myocarditis
  2. CMR acquired in an early clinical stage of myocarditis provides incremental prognostic information superior to standard clinical diagnostic tools.

Condition
Myocarditis

Study Type: Observational
Study Design: Observational Model: Case Control
Time Perspective: Prospective
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

Resource links provided by NLM:

MedlinePlus related topics: Edema MRI Scans
U.S. FDA Resources

Further study details as provided by Libin Cardiovascular Institute of Alberta:

Biospecimen Retention:   Samples With DNA

Biopsy samples with viral or bacterial DNA


Estimated Enrollment: 78
Study Start Date: January 2010
Estimated Study Completion Date: July 2011
Estimated Primary Completion Date: April 2011 (Final data collection date for primary outcome measure)
Groups/Cohorts
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.

  Show Detailed Description

  Eligibility

Ages Eligible for Study:   18 Years and older
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Sampling Method:   Probability Sample
Study Population

Patients referred for a CMR study at the Stephenson Cardiovascular MR Centre for suspected myocarditis will be screened. Patients with CMR-derived evidence for myocarditis (i.e. at least two positive Lake Louise Criteria in at least one CMR scan during the clinically acute phase of the disease) will be considered "myocarditis-positive".

As a control group, patients referred for suspected myocarditis but not fulfilling the diagnostic CMR criteria for myocarditis and with normal systolic LV function. Both groups will receive the same standard protocol as per the Consensus Group recommendations.

Criteria

Inclusion Criteria:

  1. At least 2 positive CMR criteria for myocarditis as acquired by a CMR study within less than 10 days of the onset of symptoms suggestive of myocarditis (fever, symptoms of systemic viral disease)
  2. Evidence for cardiac involvement (elevated troponin, arrhythmia and/or ECG changes)

Exclusion Criteria:

  1. Contraindication to CMR, such as implanted metal object, reaction to gadolinium, or severe claustrophobia
  2. Acute or severe renal insufficiency (rapid increase of creatinine or creatinine clearance of ≤ 30ml/min)
  Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT01307735

Locations
Canada, Alberta
Stephenson CMR Centre
Calgary, Alberta, Canada, T2N 2T9
Sponsors and Collaborators
Libin Cardiovascular Institute of Alberta
Investigators
Principal Investigator: Matthias G Friedrich, MD University of Calgary
  More Information

No publications provided

Responsible Party: Matthias Friedrich, Libin Cardiovascular Institute of Alberta
ClinicalTrials.gov Identifier: NCT01307735     History of Changes
Other Study ID Numbers: 232447
Study First Received: March 2, 2011
Last Updated: March 2, 2011
Health Authority: Conjoint Health Research Ethics Board of the University of Calgary:

Keywords provided by Libin Cardiovascular Institute of Alberta:
myocarditis
edema
hyperemia
 fibrosis
necrosis
cardiovascular magnetic resonance imaging

Additional relevant MeSH terms:
Myocarditis
Cardiomyopathies
Heart Diseases
Cardiovascular Diseases

ClinicalTrials.gov processed this record on May 22, 2013