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Cardiac Sarcoidosis and FDG-PET

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ClinicalTrials.gov Identifier: NCT00958087
Recruitment Status : Completed
First Posted : August 13, 2009
Last Update Posted : September 27, 2012
Sponsor:
Information provided by (Responsible Party):
Nobuhiro Tahara, Kurume University

Tracking Information
First Submitted Date August 12, 2009
First Posted Date August 13, 2009
Last Update Posted Date September 27, 2012
Study Start Date March 2004
Actual Primary Completion Date March 2010   (Final data collection date for primary outcome measure)
Current Primary Outcome Measures
 (submitted: August 12, 2009)
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 ]
Original Primary Outcome Measures Same as current
Change History
Current Secondary Outcome Measures
 (submitted: August 12, 2009)
  • 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 ]
  • Change from baseline in plasma dendritic cells [ Time Frame: Baseline and at 1, 3, 6, 12 months after the initial FDG-PET ]
  • 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 ]
  • 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 ]
Original Secondary Outcome Measures Same as current
Current Other Pre-specified Outcome Measures Not Provided
Original Other Pre-specified Outcome Measures Not Provided
 
Descriptive Information
Brief Title Cardiac Sarcoidosis and FDG-PET
Official Title 18F-fluorodeoxyglucose Positron Emission Tomography Imaging in Cardiac Sarcoidosis Reveals Characteristic Heterogeneity of Tracer Uptake and the Disease Activity in Myocardium
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 Type Observational
Study Design Observational Model: Cohort
Time Perspective: Prospective
Target Follow-Up Duration Not Provided
Biospecimen Not Provided
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.
Condition
  • Sarcoidosis
  • Dilated Cardiomyopathy
Intervention Not Provided
Study Groups/Cohorts
  • Sarcoidosis with cardiac involvement
  • Dilated cardiomyopathy
  • Sarcoidosis without cardiac involvement
  • Healthy controls
Publications * Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruitment Information
Recruitment Status Completed
Actual Enrollment
 (submitted: August 12, 2009)
20
Original Estimated Enrollment Same as current
Actual Study Completion Date July 2010
Actual Primary Completion Date March 2010   (Final data collection date for primary outcome measure)
Eligibility Criteria

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
Sex/Gender
Sexes Eligible for Study: All
Ages 35 Years to 85 Years   (Adult, Older Adult)
Accepts Healthy Volunteers Yes
Contacts Contact information is only displayed when the study is recruiting subjects
Listed Location Countries Japan
Removed Location Countries  
 
Administrative Information
NCT Number NCT00958087
Other Study ID Numbers CS-PET
Has Data Monitoring Committee Yes
U.S. FDA-regulated Product Not Provided
IPD Sharing Statement Not Provided
Responsible Party Nobuhiro Tahara, Kurume University
Study Sponsor Kurume University
Collaborators Not Provided
Investigators
Principal Investigator: Nobuhiro Tahara, MD, PhD Kurume University
PRS Account Kurume University
Verification Date July 2010