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PET MRI Study in Patients With Cardiac Sarcoidosis

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ClinicalTrials.gov Identifier: NCT03356756
Recruitment Status : Recruiting
First Posted : November 29, 2017
Last Update Posted : December 1, 2017
Sponsor:
Information provided by (Responsible Party):

Study Description
Brief Summary:
Myocarditis or inflammatory cardiomyopathy refers to inflammation of the heart muscle (the myocardium). Sarcoidosis is a multisystem granulomatous disorder that may involve the heart, causing inflammation, and potentially resulting in complications including arrhythmia and sudden death. The objective of this study is to evaluate the diagnostic and prognostic significance of simultaneous combined 18F-FDG PET and cardiac MRI imaging in the evaluation of inflammatory cardiomyopathies including cardiac sarcoidosis. Combined PET/MRI imaging may allow for detection and quantification of active myocardial inflammation as well as chronic fibrosis and scarring. Results of this study may allow for earlier detection of cardiac inflammation when compared with methods in current clinical use, and may lead to better understanding of the disease processes contributing to adverse outcomes. Elucidation of imaging findings associated with future adverse event risk may impact patient management such as providing an indication for pacemaker or defibrillator implantation, or escalation of medical therapy.

Condition or disease Intervention/treatment
Inflammatory Cardiomyopathy Sarcoidosis Diagnostic Test: simultaneous combined 18F-FDG PET and cardiac MRI imaging

Detailed Description:

Myocarditis or inflammatory cardiomyopathy refers to inflammation of the myocardium. Sarcoidosis is a multisystem granulomatous disorder of unknown etiology, which can result in myocardial inflammation. Approximately 5% of patients with sarcoidosis have clinically apparent cardiac involvement, yet autopsy series indicate that cardiac involvement is present in up to 25% of cases. This discrepancy suggests that cardiac sarcoidosis may be under-diagnosed in clinical practice. Recent studies have demonstrated high diagnostic accuracy of both cardiac MRI and 18F-labelled fluoro-2-deoxyglucose (FDG) PET for detection of cardiac involvement. However, cardiac MRI may fail to identify areas of active inflammation even with fluid sensitive T2-weighted sequences.

Fasting 18F-FDG positron emission tomography (PET) has been shown to identify early cardiac sarcoidosis with relatively high sensitivity. To date, simultaneous PET/MRI evaluation of cardiac inflammation and sarcoidosis has only been described in limited case reports. The objective of the proposed research is to evaluate the utility of simultaneous PET/MRI imaging in patients with cardiac sarcoidosis and other inflammatory cardiomyopathies.


Study Design

Study Type : Observational
Estimated Enrollment : 60 participants
Observational Model: Cohort
Time Perspective: Prospective
Official Title: Diagnostic and Prognostic Significance of Combined PET/MRI in Inflammatory Cardiomyopathies and Sarcoidosis
Actual Study Start Date : June 27, 2016
Estimated Primary Completion Date : December 31, 2018
Estimated Study Completion Date : December 31, 2019

Resource links provided by the National Library of Medicine

U.S. FDA Resources

Groups and Cohorts

Group/Cohort Intervention/treatment
PET MRI exam
simultaneous combined 18F-FDG PET and cardiac MRI imaging (PET MRI) performed immediately after the PET CT exam.
Diagnostic Test: simultaneous combined 18F-FDG PET and cardiac MRI imaging
Patients will undergo a research study performed with an integrated whole-body PET/MRI imaging system designed for simultaneous PET and MRI acquisition, immediately after standard of care PET/CT exam.


Outcome Measures

Primary Outcome Measures :
  1. The incremental value of combined 18F-FDG PET and cardiac MRI imaging in the evaluation of patients with suspected cardiac sarcoidosis or cardiac inflammation [ Time Frame: Completion of enrollment, an average of two years ]
    Patients will undergo standard clinical evaluation using modified consensus guidelines for the diagnosis of sarcoidosis. Following enrolment, patients will also undergo parallel assessment for cardiac involvement by PET/MRI. Comparison of cardiac involvement identified by modified consensus criteria and PET/MRI will be performed.


Secondary Outcome Measures :
  1. The differences in circulating plasma biomarkers between cardiac with suspected cardiac sarcoidosis and healthy people [ Time Frame: Completion of enrollment, an average of two years ]
    A cohort of 15 healthy volunteers will be recruited for comparison of patients with suspected cardiac sarcoidosis. Biomarkers such as microRNA will be analyzed in both groups.

  2. The prognostic significance of PET-MRI imaging findings in patients with cardiac inflammation [ Time Frame: Through study completion, an average of three years ]
    Clinical follow-up to track adverse events to validate imaging findings and determine their prognostic significance.


Eligibility Criteria

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Ages Eligible for Study:   18 Years and older   (Adult, Senior)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Sampling Method:   Non-Probability Sample
Study Population
Patients 18 years or older with known or suspected cardiac sarcoidosis or other inflammatory cardiomyopathy who are referred for clinically indicated 18F-FDG PET/CT imaging at University Health Network.
Criteria

Inclusion Criteria:

  • The primary criterion for enrolment will be patients ≥18 years of age with known or suspected sarcoidosis or other inflammatory cardiomyopathy who are referred for clinically indicated 18F-FDG PET/CT imaging

Exclusion Criteria:

  • Standard cardiac MRI contraindications include arrhythmia, claustrophobia, history of allergic reaction or other contraindication to gadolinium-based contrast agent, impaired renal function with eGFR < 60 ml/min/1.73m2, pregnancy, breast-feeding, or any other general contraindication to MRI (pacemaker, cerebral aneurysm clips, shrapnel, etc).
Contacts and Locations

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03356756


Contacts
Contact: Kate Hanneman, MD 416-323-6400 ext 5521 Kate.Hanneman@uhn.ca

Locations
Canada, Ontario
University Health Network Recruiting
Toronto, Ontario, Canada, M5G 2C4
Contact: Kate Hanneman, MD    416-323-6400 ext 5521    Kate.Hanneman@uhn.ca   
Sponsors and Collaborators
University Health Network, Toronto
Investigators
Principal Investigator: Kate Hanneman, MD University Health Network, Toronto
More Information

Responsible Party: University Health Network, Toronto
ClinicalTrials.gov Identifier: NCT03356756     History of Changes
Other Study ID Numbers: CAPCR 15-9933
First Posted: November 29, 2017    Key Record Dates
Last Update Posted: December 1, 2017
Last Verified: October 2017

Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No

Additional relevant MeSH terms:
Cardiomyopathies
Sarcoidosis
Heart Diseases
Cardiovascular Diseases
Lymphoproliferative Disorders
Lymphatic Diseases
Fluorodeoxyglucose F18
Radiopharmaceuticals
Molecular Mechanisms of Pharmacological Action