Skip to main content
Clinical Trials/NCT03777839
NCT03777839
Completed
Not Applicable

Evaluation of 18F-Fluorodeoxyglucose Positron Emission Tomography Imaging in Myocarditis

Montreal Heart Institute1 site in 1 country25 target enrollmentNovember 20, 2018

Overview

Phase
Not Applicable
Intervention
Not specified
Conditions
Myocarditis
Sponsor
Montreal Heart Institute
Enrollment
25
Locations
1
Primary Endpoint
Sensitivity of FDG PET/CT imaging with rest perfusion imaging to detect myocarditis
Status
Completed
Last Updated
last year

Overview

Brief Summary

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

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.

Registry
clinicaltrials.gov
Start Date
November 20, 2018
End Date
August 31, 2024
Last Updated
last year
Study Type
Observational
Sex
All

Investigators

Sponsor
Montreal Heart Institute
Responsible Party
Principal Investigator
Principal Investigator

Matthieu Pelletier-Galarneau, MD MSc

Adjunct Professor of Clinic

Montreal Heart Institute

Eligibility Criteria

Inclusion Criteria

  • 18 years of age or older
  • Clinical suspicion of myocarditis due to findings such as:
  • Symptoms and signs of myocarditis such as dyspnea, orthopnea, palpitation, and chest pain, without other identifiable cause
  • New onset of cardiovascular symptoms with recent history of viral disease or previous myocarditis
  • Unexplained new onset of left ventricular dysfunction
  • Unexplained elevated troponin
  • Magnetic resonance imaging findings suggestive of myocarditis, such as late gadolinium enhancement and edema
  • Biopsy findings compatible with myocarditis
  • Women of childbearing potential must have a negative urine or blood pregnancy test
  • Capable of giving informed consent and the consent must be obtained prior to any study related procedures

Exclusion Criteria

  • Female subject who is pregnant or breastfeeding and unwilling to stop for 24h
  • Claustrophobia or inability to lie still in a supine position for imaging purposes
  • Unwillingness or inability to provide informed consent

Outcomes

Primary Outcomes

Sensitivity of FDG PET/CT imaging with rest perfusion imaging to detect myocarditis

Time Frame: 1 year

Sensitivity of FDG-PET/CT with rest perfusion imaging

Secondary Outcomes

  • Left ventricular ejection fraction(1 year)
  • Specificity and accuracy of FDG-PET/CT with rest perfusion imaging to detect myocarditis(1 year)

Study Sites (1)

Loading locations...

Similar Trials