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Cardiac Sarcoidosis and FDG-PET

Sponsor
Kurume University (Other)
Overall Status
Completed
CT.gov ID
NCT00958087
Collaborator
(none)
20
Enrollment
1
Location
76
Duration (Months)
0.3
Patients Per Site Per Month

Study Details

Study Description

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 Intervention/Treatment Phase

    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 Design

    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 :
    Mar 1, 2004
    Actual Primary Completion Date :
    Mar 1, 2010
    Actual Study Completion Date :
    Jul 1, 2010

    Arms and Interventions

    Arm Intervention/Treatment
    Sarcoidosis with cardiac involvement
    Dilated cardiomyopathy
    Sarcoidosis without cardiac involvement
    Healthy controls

    Outcome Measures

    Primary Outcome Measures

    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 Outcome Measures

    1. Change from baseline in circulating markers of inflammatory and sarcoidosis [Baseline and at 1, 3, 6, 12 months after the initial FDG-PET]

    2. Change from baseline in plasma dendritic cells [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 [Baseline and at 1, 3, 6, 12 months after the initial FDG-PET]

    4. All cardiovascular events and all cause death for 5 years [Baseline and at 1, 3, 6, 12 months after the initial FDG-PET]

    Eligibility Criteria

    Criteria

    Ages Eligible for Study:
    35 Years to 85 Years
    Sexes Eligible for Study:
    All
    Accepts Healthy Volunteers:
    Yes
    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

    Locations

    Site City State Country Postal Code
    1 Kurume University Hospital Kurume city Japan 830-0011

    Sponsors and Collaborators

    • Kurume University

    Investigators

    • Principal Investigator: Nobuhiro Tahara, MD, PhD, Kurume University

    Study Documents (Full-Text)

    None provided.

    More Information

    Publications

    None provided.
    Responsible Party:
    Nobuhiro Tahara, M.D., PhD, Kurume University
    ClinicalTrials.gov Identifier:
    NCT00958087
    Other Study ID Numbers:
    • CS-PET
    First Posted:
    Aug 13, 2009
    Last Update Posted:
    Sep 27, 2012
    Last Verified:
    Jul 1, 2010
    Additional relevant MeSH terms:
    Cardiomyopathies
    Cardiomyopathy, Dilated
    Sarcoidosis

    Study Results

    No Results Posted as of Sep 27, 2012