18F-fluorodeoxyglucose Positron Emission Tomography Imaging in Cardiac Sarcoidosis Reveals Characteristic Heterogeneity of Tracer Uptake and the Disease Activity in Myocardium
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 20
- 试验地点
- 1
- 主要终点
- Usefulness of Fasting FDG-PET for Diagnosis and Management of Cardiac Sarcoidosis
研究概览
简要总结
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.
详细描述
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.
研究设计
- 研究类型
- Observational
- 观察模型
- Cohort
- 时间视角
- Prospective
入排标准
- 年龄范围
- 35 Years 至 85 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 是
入选标准
- •Subjects between the ages of 35 and 85 years
- •Subjects with systemic sarcoidosis
- •Subjects with idiopathic sarcoidosis
排除标准
- •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
结局指标
主要结局
Usefulness of Fasting FDG-PET for Diagnosis and Management of Cardiac Sarcoidosis
时间窗: Baseline and at 1, 3, 6, 12 months after the initial FDG-PET
次要结局
- Change from baseline in circulating markers of inflammatory and sarcoidosis(Baseline and at 1, 3, 6, 12 months after the initial FDG-PET)
- Change from baseline in plasma dendritic cells(Baseline and at 1, 3, 6, 12 months after the initial FDG-PET)
- Change from baseline in plasma BNP, AGE, RAGE, and PEDF levels(Baseline and at 1, 3, 6, 12 months after the initial FDG-PET)
- All cardiovascular events and all cause death for 5 years(Baseline and at 1, 3, 6, 12 months after the initial FDG-PET)
研究者
Nobuhiro Tahara
M.D., PhD
Kurume University