Cardiac Sarcoidosis and FDG-PET

Study Overview
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Brief Summary
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Sarcoidosis is a multi-systemic inflammatory disorder of unknown cause characterized by the formation of non-caseating granulomas in involved organs. Its cardiac involvement may be potentially fatal. Although endomyocardial biopsy is required for deﬁnitive diagnosis of cardiac sarcoidosis, it is invasive and lacks sensitivity. The specific diagnostic tool for cardiac sarcoidosis is far from satisfactory. Recent studies have revealed that FDG-PET with under fasting conditions is a useful method for identiﬁcation of cardiac sarcoidosis patients. However, to our knowledge, no investigations have been published with regard to FDG quantification for the diagnosis and management of cardiac sarcoidosis by PET.

Detailed Description
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Fasting FDG-PET will be performed in all subjects. Serum calcium, C-reactive protein (CRP), angiotensin converting enzyme (ACE), lysozyme, and B-type natriuretic peptide (BNP) levels will be measured in all patients. All patients will undergo chest X-ray, resting 12-lead ECG, transthoracic echocardiography, and 3 types of radionucleotide imaging using Tc-99m sestamibi for myocardial perfusion, Ga and FDG for whole-body evaluation. All assessments will be conducted within 2 weeks and no sign indicated any change in disease activity of sarcoidosis. The patients with cardiac involvement will be treated with 30 mg/day of prednisolone orally for the first 4 weeks, then will decrease to a dose of 20 mg/day for the next 4 weeks, and will maintain to a dose of 10 mg/day afterwards.

Official Title
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18F-fluorodeoxyglucose Positron Emission Tomography Imaging in Cardiac Sarcoidosis Reveals Characteristic Heterogeneity of Tracer Uptake and the Disease Activity in Myocardium

Conditions
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Sarcoidosis, Dilated Cardiomyopathy

Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: Subjects between the ages of 35 and 85 years Subjects with systemic sarcoidosis Subjects with idiopathic sarcoidosis Exclusion Criteria: Subjects with active inflammatory diseases not related to sarcoidosis Subjects with coronary artery disease and primary valvular heart diseases Subjects with uncontrolled diabetes mellitus or insulin treatment Subjects with use of the corticosteroid Subjects with systemic disorders such as active inflammatory, liver, renal, hematopoietic, and malignant disease

Ages Eligible for Study
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Minimum Age: 35 Years
Maximum Age: 85 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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Accepts Healthy Volunteers

Study Plan
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How is the study designed?
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Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Sarcoidosis with cardiac involvement<br> | |
| Dilated cardiomyopathy<br> | |
| Sarcoidosis without cardiac involvement<br> | |
| Healthy controls<br> | |

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Usefulness of Fasting FDG-PET for Diagnosis and Management of Cardiac Sarcoidosis |  | Baseline and at 1, 3, 6, 12 months after the initial FDG-PET | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Change from baseline in circulating markers of inflammatory and sarcoidosis |  | Baseline and at 1, 3, 6, 12 months after the initial FDG-PET | 
| Change from baseline in plasma dendritic cells |  | Baseline and at 1, 3, 6, 12 months after the initial FDG-PET | 
| Change from baseline in plasma BNP, AGE, RAGE, and PEDF levels |  | Baseline and at 1, 3, 6, 12 months after the initial FDG-PET | 
| All cardiovascular events and all cause death for 5 years |  | Baseline and at 1, 3, 6, 12 months after the initial FDG-PET |