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Cardiac Sarcoidosis and FDG-PET

This study has been completed.
Sponsor:
Information provided by (Responsible Party):
Nobuhiro Tahara, Kurume University
ClinicalTrials.gov Identifier:
NCT00958087
First received: August 12, 2009
Last updated: September 26, 2012
Last verified: July 2010

August 12, 2009
September 26, 2012
March 2004
March 2010   (final data collection date for primary outcome measure)
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 ] [ Designated as safety issue: Yes ]
Same as current
Complete list of historical versions of study NCT00958087 on ClinicalTrials.gov Archive Site
  • 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 ] [ Designated as safety issue: Yes ]
  • Change from baseline in plasma dendritic cells [ Time Frame: Baseline and at 1, 3, 6, 12 months after the initial FDG-PET ] [ Designated as safety issue: Yes ]
  • 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 ] [ Designated as safety issue: Yes ]
  • 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 ] [ Designated as safety issue: Yes ]
Same as current
Not Provided
Not Provided
 
Cardiac Sarcoidosis and FDG-PET
18F-fluorodeoxyglucose Positron Emission Tomography Imaging in Cardiac Sarcoidosis Reveals Characteristic Heterogeneity of Tracer Uptake and the Disease Activity in Myocardium

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.

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.

Observational
Observational Model: Cohort
Time Perspective: Prospective
Not Provided
Not Provided
Probability Sample

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.

  • Sarcoidosis
  • Dilated Cardiomyopathy
Not Provided
  • Sarcoidosis with cardiac involvement
  • Dilated cardiomyopathy
  • Sarcoidosis without cardiac involvement
  • Healthy controls
Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Completed
20
July 2010
March 2010   (final data collection date for primary outcome measure)

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
Both
35 Years to 85 Years
Yes
Contact information is only displayed when the study is recruiting subjects
Japan
 
NCT00958087
CS-PET
Yes
Nobuhiro Tahara, Kurume University
Kurume University
Not Provided
Principal Investigator: Nobuhiro Tahara, MD, PhD Kurume University
Kurume University
July 2010

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP