PETMYO: PET-FDG in Myocarditis

Sponsor
Montreal Heart Institute (Other)
Overall Status
Recruiting
CT.gov ID
NCT03777839
Collaborator
(none)
50
Enrollment
1
Location
48.4
Anticipated Duration (Months)
1
Patients Per Site Per Month

Study Details

Study Description

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.

Condition or DiseaseIntervention/TreatmentPhase
  • Diagnostic Test: FDG PET/CT

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.

Study Design

Study Type:
Observational
Anticipated Enrollment :
50 participants
Observational Model:
Cohort
Time Perspective:
Prospective
Official Title:
Evaluation of 18F-Fluorodeoxyglucose Positron Emission Tomography Imaging in Myocarditis
Actual Study Start Date :
Nov 20, 2018
Anticipated Primary Completion Date :
Dec 1, 2022
Anticipated Study Completion Date :
Dec 1, 2022

Outcome Measures

Primary Outcome Measures

  1. Sensitivity of FDG PET/CT imaging with rest perfusion imaging to detect myocarditis [1 year]

    Sensitivity of FDG-PET/CT with rest perfusion imaging

Secondary Outcome Measures

  1. Specificity and accuracy of FDG-PET/CT with rest perfusion imaging to detect myocarditis [1 year]

    Specificity and accuracy of FDG-PET/CT with rest perfusion imaging

  2. Left ventricular ejection fraction [1 year]

    The association between subjects' outcome and quantitative assessment of left ventricular inflammation and scar will be evaluated

Eligibility Criteria

Criteria

Ages Eligible for Study:
18 Years and Older
Sexes Eligible for Study:
All
Accepts Healthy Volunteers:
No
Inclusion Criteria:
  1. 18 years of age or older

  2. Clinical suspicion of myocarditis due to findings such as:

  3. Symptoms and signs of myocarditis such as dyspnea, orthopnea, palpitation, and chest pain, without other identifiable cause

  4. New onset of cardiovascular symptoms with recent history of viral disease or previous myocarditis

  5. Unexplained new onset of left ventricular dysfunction

  6. Unexplained elevated troponin

  7. Magnetic resonance imaging findings suggestive of myocarditis, such as late gadolinium enhancement and edema

  8. Biopsy findings compatible with myocarditis

  9. Women of childbearing potential must have a negative urine or blood pregnancy test

  10. Capable of giving informed consent and the consent must be obtained prior to any study related procedures

  11. 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

Contacts and Locations

Locations

SiteCityStateCountryPostal Code
1Matthieu Pelletier-GalarneauMontrealQuebecCanadaH3L3C1

Sponsors and Collaborators

  • Montreal Heart Institute

Investigators

None specified.

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.
Responsible Party:
Matthieu Pelletier-Galarneau, MD MSc, Adjunct Professor of Clinic, Montreal Heart Institute
ClinicalTrials.gov Identifier:
NCT03777839
Other Study ID Numbers:
  • 2019-2395
First Posted:
Dec 17, 2018
Last Update Posted:
Mar 11, 2021
Last Verified:
Mar 1, 2021
Individual Participant Data (IPD) Sharing Statement:
Undecided
Plan to Share IPD:
Undecided
Studies a U.S. FDA-regulated Drug Product:
No
Studies a U.S. FDA-regulated Device Product:
No
Additional relevant MeSH terms:

Study Results

No Results Posted as of Mar 11, 2021