PET-FDG in Myocarditis

NCT ID: NCT03777839

Last Updated: 2024-11-22

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Total Enrollment

25 participants

Study Classification

OBSERVATIONAL

Study Start Date

2018-11-20

Study Completion Date

2024-08-31

Brief Summary

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This study evaluates the diagnostic performance of 18F-2-fluoro-2-deoxy-D-glucose fluorodeoxyglucose (FDG) positron emission tomography/computed tomography (PET/CT) with rest perfusion imaging for the diagnosis of myocarditis. Patients with clinical suspicion of myocarditis will be recruited and undergo a rest myocardial perfusion scan and a FDG PET/CT scan following a myocardial suppression protocol.

Detailed Description

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Myocarditis is characterized by myocardial inflammation, which can lead to fibrosis and heart failure.

FDG PET/CT, with appropriate suppression protocol including high-fat-low-carbohydrate diet, fasting, and IV heparin, can be use to detect myocardial inflammation. It is frequently used for the diagnosis of inflammation in cardiac sarcoidosis. After the initial inflammatory phase, inflammation resolves and fibrosis can seen. Resting perfusion imaging will allow identification of fibrosis. The combination of FDG PET/CT and rest perfusion imaging could allow detection of the various phases of myocarditis; inflammation and fibrosis.

Conditions

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Myocarditis Viral Myocarditis

Study Design

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Observational Model Type

COHORT

Study Time Perspective

PROSPECTIVE

Interventions

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FDG PET/CT

FDG PET CT imaging with rest perfusion imaging

Intervention Type DIAGNOSTIC_TEST

Eligibility Criteria

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Inclusion Criteria

1. 18 years of age or older
2. Clinical suspicion of myocarditis due to findings such as:

1. Symptoms and signs of myocarditis such as dyspnea, orthopnea, palpitation, and chest pain, without other identifiable cause
2. New onset of cardiovascular symptoms with recent history of viral disease or previous myocarditis
3. Unexplained new onset of left ventricular dysfunction
4. Unexplained elevated troponin
5. Magnetic resonance imaging findings suggestive of myocarditis, such as late gadolinium enhancement and edema
6. Biopsy findings compatible with myocarditis
3. Women of childbearing potential must have a negative urine or blood pregnancy test
4. Capable of giving informed consent and the consent must be obtained prior to any study related procedures
5. Subject's with body mass index inferior or equal to 45 kg/m2

Exclusion Criteria

1. Female subject who is pregnant or breastfeeding and unwilling to stop for 24h
2. Claustrophobia or inability to lie still in a supine position for imaging purposes
3. Unwillingness or inability to provide informed consent
Minimum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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Montreal Heart Institute

OTHER

Sponsor Role lead

Responsible Party

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Matthieu Pelletier-Galarneau, MD MSc

Adjunct Professor of Clinic

Responsibility Role PRINCIPAL_INVESTIGATOR

Locations

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Matthieu Pelletier-Galarneau

Montreal, Quebec, Canada

Site Status

Countries

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Canada

Other Identifiers

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2019-2395

Identifier Type: -

Identifier Source: org_study_id

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