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Cardiac Sarcoidosis and FDG-PET

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details. Identifier: NCT00958087
Recruitment Status : Completed
First Posted : August 13, 2009
Last Update Posted : September 27, 2012
Information provided by (Responsible Party):
Nobuhiro Tahara, 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.

Condition or disease
Sarcoidosis Dilated Cardiomyopathy

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 Type : Observational
Actual Enrollment : 20 participants
Observational Model: Cohort
Time Perspective: Prospective
Official Title: 18F-fluorodeoxyglucose Positron Emission Tomography Imaging in Cardiac Sarcoidosis Reveals Characteristic Heterogeneity of Tracer Uptake and the Disease Activity in Myocardium
Study Start Date : March 2004
Primary Completion Date : March 2010
Study Completion Date : July 2010

Sarcoidosis with cardiac involvement
Dilated cardiomyopathy
Sarcoidosis without cardiac involvement
Healthy controls

Primary Outcome Measures :
  1. Usefulness of Fasting FDG-PET for Diagnosis and Management of Cardiac Sarcoidosis [ Time Frame: Baseline and at 1, 3, 6, 12 months after the initial FDG-PET ]

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

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Ages Eligible for Study:   35 Years to 85 Years   (Adult, Senior)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   Yes
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.

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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its identifier (NCT number): NCT00958087

Kurume University Hospital
Kurume city, Japan, 830-0011
Sponsors and Collaborators
Kurume University
Principal Investigator: Nobuhiro Tahara, MD, PhD Kurume University

Responsible Party: Nobuhiro Tahara, M.D., PhD, Kurume University Identifier: NCT00958087     History of Changes
Other Study ID Numbers: CS-PET
First Posted: August 13, 2009    Key Record Dates
Last Update Posted: September 27, 2012
Last Verified: July 2010

Additional relevant MeSH terms:
Cardiomyopathy, Dilated
Heart Diseases
Cardiovascular Diseases
Lymphoproliferative Disorders
Lymphatic Diseases