EUCTR2018-001719-65-NL进行中（未招募）1 期
CALCification as an early marker of vasculopathy and organ involvement in Systemic Sclerosis CALC-SSc study - CALC-SSc study
niversity Medial Center Groningen0 个研究点目标入组 120 人开始时间: 2018年7月9日最近更新:
适应症
试验速览
- 阶段
- 1 期
- 状态
- 进行中（未招募）
- 发起方
- 入组人数
- 120
研究概览
简要总结
暂无简介。
研究设计
- 研究类型
- Interventional clinical trial of medicinal product
入排标准
入选标准
- •SSc patients:
- •In order to be eligible to participate in this study as an SSc patient, a subject must meet all of the following criteria:
- •18-80 years
- •Formal diagnosis of Systemic Sclerosis, as determined by a total of =9 from adding the maximum weight (score) in each of the following categories (2013 ACR/EULAR criteria):
- •oSkin thickening of the fingers of both hands extending proximal to the metacarpophalangeal joints (sufficient criterion) (9 points)
- •oSkin thickening of the fingers (only count the higher score)
- •?Puffy fingers (2 points)
- •?Sclerodactyly of the fingers (distal to the metacarpophalangeal joints but proximal to the proximal interphalangeal joints) (4 points)
- •oFingertip lesions (only count the higher score)
- •?Digital tip ulcers (2 points)
- •?Fingertip pitting scars (3 points)
- •oTelangiectasia (2 points)
- •oAbnormal nailfold capillaries (2 points)
- •oPulmonary involvement (maximum score is 2)
- •?Pulmonary arterial hypertension (2 points)
- •?Interstitial lung disease (2 points)
- •oRaynaud’s phenomenon (3 points)
- •oSSc-related autoantibodies (maximum score is 3)
- •?Anticentromere (3 points)
- •?anti–topoisomerase I [anti–Scl-70] (3 points)
- •?anti–RNA polymerase III (3 points)
- •Written informed consent
- •In order to be eligible to participate in this study as a patient with primary Raynaud’s phenomenon, a subject must meet all of the following criteria:
- •18-80 years
- •Negatieve antinuclear antibodies (ANA)
- •Normal nailfold capillairies
- •No underlying disease
- •Written informed consent
- •Healthy controls:
- •In order to be eligible to participate in this study as a healthy control, a subject must meet all of the following criteria:
- •18-80 years
- •No apparent underlying chronic disease
- •No signs and symptoms suggesting Raynaud phenomenon or other vascular disease
- •Written informed consent
- •Are the trial subjects under 18? no
- •Number of subjects for this age range:
- •F.1.2 Adults (18-64 years) yes
- •F.1.2.1 Number of subjects for this age range 120
- •F.1.3 Elderly (>=65 years) no
- •F.1.3.1 Number of subjects for this age range
排除标准
- •A potential subject who meets any of the following criteria will be excluded from participation in this study:
- •Women who are currently pregnant, planning to become pregnant, breastfeeding women, or women with child bearing potential not using appropriate contraceptive measures
- •Patients who are mentally incompetent and cannot sign a Patient Informed Consent or are unwilling to sign a Patient Informed Consent
- •Vascular event in the preceding 3 months (33)
- •Chemotherapy in the preceding 3 months (33)
- •Inflammation of unknown origin, sepsis, or vasculitis (34)
- •The next criteria will also be used for the substudy concerning 18F-NaF PET/CT:
- •Current active bone malignancy or in the previous 6 months (35)
- •Fractures or metastases within the evaluated bone regions, as well as metallic implants (33)
- •Disorders affecting bone metabolism, e.g. hyperparathyroidism, Paget’s disease (33)
- •Patients who have claustrophobia (16)
- •Prior or present bisphosphonate therapy (33)
- •Prior or present calcium or vitamin D therapy
研究者
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