Clinical trial NCT00958087: 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
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Sarcoidosis
Dilated Cardiomyopathy
Lead sponsor: Kurume University
Sponsor class: OTHER
First posted: 2009-08-13
Enrollment: 20
Sex: ALL
Minimum age (years): 35
Maximum age (years): 85
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Observational model: COHORT
Time perspective: PROSPECTIVE
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.

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.

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

Primary outcomes:
measure: Usefulness of Fasting FDG-PET for Diagnosis and Management of Cardiac Sarcoidosis
timeFrame: Baseline and at 1, 3, 6, 12 months after the initial FDG-PET
Secondary outcomes:
measure: Change from baseline in circulating markers of inflammatory and sarcoidosis
timeFrame: Baseline and at 1, 3, 6, 12 months after the initial FDG-PET
measure: Change from baseline in plasma dendritic cells
timeFrame: Baseline and at 1, 3, 6, 12 months after the initial FDG-PET
measure: Change from baseline in plasma BNP, AGE, RAGE, and PEDF levels
timeFrame: Baseline and at 1, 3, 6, 12 months after the initial FDG-PET
measure: All cardiovascular events and all cause death for 5 years
timeFrame: Baseline and at 1, 3, 6, 12 months after the initial FDG-PET
Other outcomes:
Locations:
city: Kurume city
country: Japan
facility: Kurume University Hospital
Study officials:
affiliation: Kurume University
name: Nobuhiro Tahara, MD, PhD
role: PRINCIPAL_INVESTIGATOR
References: