PET-FDG in Myocarditis (PETMYO)

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

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.

Study Overview

• Status: Completed
• Conditions: Myocarditis; Viral Myocarditis
• Intervention / Treatment: 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 Type: Observational
• Enrollment (Actual): 25

Contacts and Locations

Study Locations

• Canada
  • Quebec
    • Montreal, Quebec, Canada, H3L3C1
      • Matthieu Pelletier-Galarneau

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: No

• Sampling Method: Non-Probability Sample

Study Population

A total of 50 subjects with high clinical suspicion of myocarditis will be enrolled.

Description

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

Study Plan

How is the study designed?

Design Details

• Observational Models: Cohort
• Time Perspectives: Prospective

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Sensitivity of FDG PET/CT imaging with rest perfusion imaging to detect myocarditis	Sensitivity of FDG-PET/CT with rest perfusion imaging	1 year

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Specificity and accuracy of FDG-PET/CT with rest perfusion imaging to detect myocarditis	Specificity and accuracy of FDG-PET/CT with rest perfusion imaging	1 year
Left ventricular ejection fraction	The association between subjects' outcome and quantitative assessment of left ventricular inflammation and scar will be evaluated	1 year

Collaborators and Investigators

• Sponsor: Montreal Heart Institute

Study record dates

Study Major Dates

• Study Start (Actual): November 20, 2018
• Primary Completion (Actual): August 31, 2024
• Study Completion (Actual): August 31, 2024

Study Registration Dates

• First Submitted: December 13, 2018
• First Submitted That Met QC Criteria: December 14, 2018
• First Posted (Actual): December 17, 2018

Study Record Updates

• Last Update Posted (Estimated): November 22, 2024
• Last Update Submitted That Met QC Criteria: November 19, 2024
• Last Verified: October 1, 2023

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Cardiovascular Diseases; Heart Diseases; Cardiomyopathies; Myocarditis
• Other Study ID Numbers: 2019-2395

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: UNDECIDED

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No
• product manufactured in and exported from the U.S.: No