NL-OMON48902招募中不适用
CALCification as an early marker of vasculopathy and organ involvement in Systemic Sclerosis - CALC-SSc study
适应症
试验速览
- 阶段
- 不适用
- 状态
- 招募中
- 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
- Observational
入排标准
- 年龄范围
- 18 至 99（—）
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 years and older;* 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):;o Skin thickening of the fingers of both hands extending proximal to the metacarpophalangeal joints (sufficient criterion) (9 points);o Skin 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);o Fingertip lesions (only count the higher score) ;* Digital tip ulcers (2 points);* Fingertip pitting scars (3 points);o Telangiectasia (2 points);o Abnormal nailfold capillaries (2 points);o Pulmonary involvement (maximum score is 2);* Pulmonary arterial hypertension (2 points) ;* Interstitial lung disease (2 points);o Raynaud*s phenomenon (3 points);o SSc-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;Controls:;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 years and older;* 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 years and older;* No apparent underlying chronic disease;* No signs and symptoms suggesting Raynaud phenomenon or other vascular disease;* Written informed consent
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;* Chemotherapy in the preceding 3 months;* Inflammation of unknown origin, sepsis, or vasculitis;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 ;* Disorders affecting bone metabolism, e.g. hyperparathyroidism, Paget*s disease ;* Patients who have claustrophobia
研究者
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