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Completed

NCT Number: NCT00958087

Cardiac Sarcoidosis and FDG-PET

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.

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Key information

Conditions

Sarcoidosis Cardiomegaly Cardiomyopathies Cardiomyopathy, Dilated Cardiovascular Diseases Congenital, Hereditary, and Neonatal Diseases and Abnormalities Dilated Cardiomyopathy Genetic Diseases, Inborn Heart Diseases Hemic and Lymphatic Diseases Hypersensitivity Hypersensitivity, Delayed Immune System Diseases Laminopathies Lymphatic Diseases Lymphoproliferative Disorders

Age range

35 year–85 year

Sex eligibility

All sexes

Study type

Observational

Primary location

Kurume University Hospital

Kurume, 830-0011, Japan

About this study

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.

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Primary outcomes

  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 outcomes

  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

Sponsors and collaborators

Lead sponsor

Kurume University

Other

Registry information

Official study title

18F-fluorodeoxyglucose Positron Emission Tomography Imaging in Cardiac Sarcoidosis Reveals Characteristic Heterogeneity of Tracer Uptake and the Disease Activity in Myocardium

Important dates

Study start
2004
Primary completion
2010
Study completion
2010
First posted
Aug 13, 2009
Registry last updated
Sep 27, 2012

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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