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 2, 2017
|Condition or disease||Intervention/treatment|
|Inflammatory Cardiomyopathy Sarcoidosis||Diagnostic Test: simultaneous combined 18F-FDG PET and cardiac MRI imaging|
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 Type :||Observational|
|Estimated Enrollment :||60 participants|
|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|
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.
- 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.
- 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.
- 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.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03356756
|Contact: Kate Hanneman, MD||416-323-6400 ext 5521||Kate.Hanneman@uhn.ca|
|University Health Network||Recruiting|
|Toronto, Ontario, Canada, M5G 2C4|
|Contact: Kate Hanneman, MD 416-323-6400 ext 5521 Kate.Hanneman@uhn.ca|
|Principal Investigator:||Kate Hanneman, MD||University Health Network, Toronto|