Cardiac Sarcoidosis and FDG-PET

NCT00958087 | Completed DMC

• 1 other identifier: CS-PET
• Study Type: observational
• Target: 20
• Locations: 1 country
• Sites: 1

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.

Conditions

Sarcoidosis; Dilated Cardiomyopathy

Outcome Measures

Primary Outcomes (1)

• 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 Outcomes (4)

• 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

Study Arms (4)

Sarcoidosis with cardiac involvement

Dilated cardiomyopathy

Sarcoidosis without cardiac involvement

Healthy controls

Eligibility Criteria

• Age: 35 Years - 85 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)
• Sampling Method: Probability Sample

Study Population

Fasting FDG-PET will be performed in patients with sarcoidosis and age-matched DCM patients. Among them, systemic sarcoidosis will be diagnosed clinically and/or histologically, and referred for cardiac sarcoidosis. Patients with sarcoidosis will reveal cardiac involvement based on guidelines established in 2006 by the Japanese Ministry of Health and Welfare. Healthy control subjects will undergo FDG-PET.

You may qualify if:

• Subjects between the ages of 35 and 85 years
• Subjects with systemic sarcoidosis
• Subjects with idiopathic sarcoidosis

You may not qualify if:

• 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

Sponsors & Collaborators

• Kurume University: lead

Study Sites (1)

Kurume University Hospital

Kurume, 830-0011, Japan

Location

MeSH Terms

Conditions

Sarcoidosis; Cardiomyopathy, Dilated

Condition Hierarchy (Ancestors)

Lymphoproliferative Disorders; Lymphatic Diseases; Hemic and Lymphatic Diseases; Hypersensitivity, Delayed; Hypersensitivity; Immune System Diseases; Cardiomegaly; Heart Diseases; Cardiovascular Diseases; Cardiomyopathies; Laminopathies; Genetic Diseases, Inborn; Congenital, Hereditary, and Neonatal Diseases and Abnormalities

Study Officials

• Nobuhiro Tahara, MD, PhD

  Kurume University

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: PROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: M.D., PhD

Study Record Dates

• First Submitted: August 12, 2009
• First Posted: August 13, 2009
• Study Start: March 1, 2004
• Primary Completion: March 1, 2010
• Study Completion: July 1, 2010
• Last Updated: September 27, 2012

Record last verified: 2010-07

Locations

JP (1)