Polymyalgia Rheumatica and Giant Cell Arteritis - Three Challenges - Consequences of the Vasculitis Process, Osteoporosis and Malignancy: A Prospective Cohort Study Protocol
试验速览
- 阶段
- 不适用
- 发起方
- 入组人数
- 80
- 试验地点
- 1
- 主要终点
- Cumulated prednisolone dose within the first year after treatment initiation in patients with and without vasculitis in the large vessels
研究概览
简要总结
The purpose of this study is to delineate the association of the 18F-Fluorodeoxyglucose Positron Emission Tomography/Computed Tomography (18F-FDG PET/CT) detected vasculitis pattern of the large vessels (PET positivity) and the clinical picture of Polymyalgia Rheumatica (PMR)/Giant Cell Arteritis (GCA) .
详细描述
Introduction
Polymyalgia Rheumatica (PMR) and Giant Cell Arteritis (GCA) are common inflammatory conditions. The diagnosis of PMR/GCA poses many challenges since there are no specific diagnostic tests. Recent literature emphasizes the ability of 18F-Fluorodeoxyglucose Positron Emission Tomography/Computed Tomography (18F-FDG PET/CT) to assess global disease activity and/or inflammation burden. 18F-FDG PET/CT may lead to make diagnosis at an earlier stage than conventional imaging and assess response to therapy. With respect to the management of PMR/GCA, there are three significant areas of concern as follows: Vasculitis process/vascular stiffness, malignancy and osteoporosis.
Methods and Analysis:
Patients: All patients with the suspicion of PMR/GCR will be offered to participate in the study. The current protocol consists of 4 separate studies including: I) The association of clinical picture of PMR/GCA with PET detected vasculitis II) Evaluating validity of 18F-FDG PET/CT scan for diagnosis of PMR/GCA compared to temporal artery biopsy III) Incidence of new diagnosed malignancies in patients with PMR/GCA, or PMR like syndrome with the aim of PET/CT scan and Chest X ray/Abdominal ultrasound IV) Impact of disease process as well as steroid treatment on bone mineral density, body composition and vasculitis/vascular stiffness in PMR/GCA patients.
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
- 18 Years 至 95 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •At least five (A-E) components of the PMR diagnostic criteria, including:
- •A. Age ≥50 years,
- •B. Bilateral shoulder or hip pain,
- •C. Morning stiffness lasting >45 min,
- •D. Elevated erythrocyte sedimentation rate (ESR),
- •E. Elevated C-reactive protein (CRP),
- •F. Disease duration >2weeks, should be met to suspect PMR.
- •For GCA following criteria's must be seen: Age > 50 years, ESR/CRP > 50, as well as at least two symptoms related to vasculitis (scalp tenderness, vision disturbances, headache (new or changed), jaw claudication, tenderness of the temporal arteria) if patients do not simultaneously have PMR. If the patient is suspected for PMR, one cranial symptom is enough to suspect GCA.
排除标准
- •Inability to communicate in Danish
- •Infections or malignancy when prednisolone is permanently unsuitable
- •Contraindication to imaging studies (allergy to contrast materials, reduced kidney function, pregnancy and Blood Sugar (BS) >8 mmol/l after 6 hours fasting)
- •Initiation of steroid treatment before the PET scan
- •Inability to provide informed consent
结局指标
主要结局
Cumulated prednisolone dose within the first year after treatment initiation in patients with and without vasculitis in the large vessels
时间窗: One year
次要结局
- Impact of disease process and steroid treatment on Bone Mineral Content(One year)
- Patient reported pain in patients with vasculitis in the large vessels (positive PET)(One year)
- Morning stiffness (minute) in patients with vasculitis in the large vessels (positive PET)(One year)
- Patient reported global visual analogue scale (VAS) in patients with vasculitis in the large vessels (positive PET)(One year)
- Biochemistry results in patients with vasculitis in the large vessels (positive PET)(One year)
- Incidence of malignancies in the included patients detected by the aim of Chest X Ray plus abdominal Ultrasound.(One year)
- Impact of disease process and steroid treatment on Aortic Pulse Wave Velocity (PWV)(One year)
- Impact of disease process and steroid treatment on Body Mass Index(One year)
- Impact of disease process and steroid treatment on Lean Body Mass(One year)
- Impact of disease process and steroid treatment on Fat Mass(One year)
- Number of relapses in patients with vasculitis in the large vessels (positive PET)(One year)
- Proportion of PET negativity (no signs of vasculitis in the large vessels) in patients with temporal artery biopsy negative.(One year)
- Incidence of malignancies in the included patients detected by the aim of 18F-FDG PET/CT scan.(One year)
- Impact of disease process and steroid treatment on Z score(One year)
- Impact of disease process and steroid treatment on Bone Mineral Density(One year)
- Physician reported visual analogue scale (VAS) in patients with vasculitis in the large vessels (positive PET)(One year)
- Impact of disease process and steroid treatment on Fat Mass Index(One year)
- Impact of disease process and steroid treatment on upper limb PWV(One year)
- Impact of disease process and steroid treatment on Fat Free Mass Index(One year)
- Proportion of PET positivity (vasculitis in the large vessels as well as findings compatible with PMR) in patients with temporal artery biopsy positive.(One year)
- Impact of disease process and steroid treatment on Aortic augmentation index(One year)
- Impact of disease process and steroid treatment on T score(One year)
- Impact of disease process and steroid treatment on Fat Free Mass(One year)
研究者
Amir Emamifar
Doctor of Medicine
Svendborg Hospital