Cardiac Sarcoidosis and FDG-PET

Completed

• Conditions: Sarcoidosis; Dilated Cardiomyopathy

• Registration Number: NCT00958087
• Lead Sponsor: Kurume University

Brief Summary

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

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.

Study Timeline

• Study Start: 2004-03
• Study First Submitted: 2009-08-12
• Study First Submitted QC: 2009-08-12
• Study First Posted: 2009-08-13
• Primary Completion: 2010-03
• Status Verified: 2010-07
• Study Completion: 2010-07
• Last Update Submitted: 2012-09-26
• Last Update Posted: 2012-09-27

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 20

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

Study & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
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

Name	Time	Method
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

Trial Locations

Locations (1)

Kurume University Hospital; 🇯🇵 Kurume city, Japan