Cardiac Sarcoidosis and FDG-PET

Sarcoidosis Clinical Trial

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT00958087
• Other study ID #: CS-PET
• Status: Completed
• Phase: N/A
• First received: August 12, 2009
• Last updated: September 26, 2012
• Start date: March 2004
• Est. completion date: July 2010

Study information

• Verified date: July 2010
• Source: Kurume University
• Contact: n/a
• Is FDA regulated: No
• Health authority: Japan: Ministry of Health, Labor and Welfare
• Study type: Observational

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 20
• Est. completion date: July 2010
• Est. primary completion date: March 2010
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: Both
• Age group: 35 Years to 85 Years

Eligibility

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

Observational Model: Cohort, Time Perspective: Prospective

Related Conditions & MeSH terms

• Cardiomyopathies
• Cardiomyopathy, Dilated
• Dilated Cardiomyopathy
• Sarcoidosis

Locations

Country	Name	City	State
Japan	Kurume University Hospital	Kurume city

Sponsors (1)

Lead Sponsor	Collaborator
Kurume University

Country where clinical trial is conducted

Japan, 

Outcome

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