International Myocarditis Registry

NCT01307735 | Unknown DMC

• 1 other identifier: 232447
• Study Type: observational
• Target: 78
• Locations: 1 country
• Sites: 1

Brief Summary

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

Conditions

Myocarditis

Keywords

myocarditis; edema; hyperemia; fibrosis; necrosis; cardiovascular magnetic resonance imaging

Study Arms (2)

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.

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)
• 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.

You may qualify if:

• 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)
• Evidence for cardiac involvement (elevated troponin, arrhythmia and/or ECG changes)

You may not qualify if:

• Contraindication to CMR, such as implanted metal object, reaction to gadolinium, or severe claustrophobia
• Acute or severe renal insufficiency (rapid increase of creatinine or creatinine clearance of ≤ 30ml/min)

Sponsors & Collaborators

• Libin Cardiovascular Institute of Alberta: lead

Study Sites (1)

Stephenson CMR Centre

Calgary, Alberta, T2N 2T9, Canada

Location

Biospecimen

Retention: SAMPLES WITH DNA

Biopsy samples with viral or bacterial DNA

MeSH Terms

Conditions

Myocarditis; Edema; Hyperemia; Fibrosis; Necrosis

Condition Hierarchy (Ancestors)

Cardiomyopathies; Heart Diseases; Cardiovascular Diseases; Signs and Symptoms; Pathological Conditions, Signs and Symptoms; Vascular Diseases; Pathologic Processes

Study Officials

• Matthias G Friedrich, MD

  University of Calgary

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: observational
• Observational Model: CASE CONTROL
• Time Perspective: PROSPECTIVE
• Sponsor Type: OTHER

Study Record Dates

• First Submitted: March 2, 2011
• First Posted: March 3, 2011
• Study Start: January 1, 2010
• Primary Completion: April 1, 2011
• Study Completion: July 1, 2011
• Last Updated: March 3, 2011

Record last verified: 2011-02

Locations

CA (1)