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
  Purpose

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
Sarcoidosis
Dilated Cardiomyopathy

Study Type: Observational
Study Design: 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

Resource links provided by NLM:


Further study details as provided by Kurume University:

Primary Outcome Measures:
  • 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 ]

Secondary Outcome Measures:
  • 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 ]

Enrollment: 20
Study Start Date: March 2004
Study Completion Date: July 2010
Primary Completion Date: March 2010 (Final data collection date for primary outcome measure)
Groups/Cohorts
Sarcoidosis with cardiac involvement
Dilated cardiomyopathy
Sarcoidosis without cardiac involvement
Healthy controls

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.

  Eligibility

Ages Eligible for Study:   35 Years to 85 Years
Genders Eligible for Study:   Both
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.

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
  Contacts and Locations
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Please refer to this study by its ClinicalTrials.gov identifier: NCT00958087

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

No publications provided

Responsible Party: Nobuhiro Tahara, M.D., PhD, Kurume University
ClinicalTrials.gov Identifier: NCT00958087     History of Changes
Other Study ID Numbers: CS-PET
Study First Received: August 12, 2009
Last Updated: September 26, 2012
Health Authority: Japan: Ministry of Health, Labor and Welfare

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

ClinicalTrials.gov processed this record on July 23, 2014