跳至主要内容
临床试验/NCT07012655
NCT07012655已完成不适用

Color Doppler Ultrasonography Evaluation of Abdominal and Peripheral Vasculopathy in Systemic Sclerosis Patients

Assiut University1 个研究点 分布在 1 个国家目标入组 30 人开始时间: 2024年5月1日最近更新:
适应症
干预措施

试验速览

阶段
不适用
状态
已完成
入组人数
30
试验地点
1
主要终点
Macro vascular involvement in systemic sclerosis patients

研究概览

简要总结

In the current study we aim to assess the macrovascular involvement in SSc patients through an ultrasound (US) evaluation of radial and ulnar arteries and splanchnic vessels.

详细描述

Systemic sclerosis (SSc) is a connective tissue disease (CTD) characterized by diffuse cutaneous sclerosis of skin and organs, small vessel vasculopathy and immune system dysregulation associated with the production of autoantibodies.

Although small vessel vasculopathy can be considered a hallmark of this disease, large vessels can also be involved. Accordingly, involvement of medium vessels such as the ulnar artery has been evaluated in the literature, with results showing how ulnar artery occlusion (UAO) could be considered as a severity marker of vasculopathy as well as a predictive marker of digital ulcers (DUs), which are typically more frequent in patients with limited cutaneous (lc) SSc.

The gastrointestinal (GI) tract is one of the most frequently involved organs, affecting the majority (75-90%) of SSc patients.

GI involvement is often largely asymptomatic because it is frequently subclinical until severe tissue damage occurs. Once symptoms occur, SSc-related GI involvement heavily impacts morbidity and mortality, with patients experiencing significant emotional and social burdens and decreased survival in severe cases.

Unfortunately, the diagnosis of GI involvement is challenging because it is often delayed by the paucity of signs and symptoms early in the disease. Moreover, several diagnostic investigations that are useful in defning GI involvement are either invasive, expensive or not very informative.

研究设计

研究类型
Observational
观察模型
Case Control
时间视角
Cross Sectional

入排标准

年龄范围
18 Years 至 —(Adult, Older Adult)
性别
All
接受健康志愿者
是

入选标准

  • •Adult systemic sclerosis patients fulfilling the criteria for the diagnosis by American College of Rheumatology /European league against rheumatism 2013 classification criteria for systemic sclerosis, who accept to participate in the current study.

排除标准

  • •Individuals with other autoimmune diseases (rheumatoid arthritis, dermatomyositis, mixed connective tissue disease).
  • •those who Refuse to participate in the current study.

研究组 & 干预措施

未命名试验

干预措施: Colour Doppler Ultrasound (Device)

结局指标

主要结局

Macro vascular involvement in systemic sclerosis patients

时间窗: day 1

Assess the macro vascular involvement in SSc patients through an ultrasound (US) evaluation of radial and ulnar arteries and splanchnic vessels.

次要结局

未报告次要终点

研究者

申办方类型
Other
责任方
Principal Investigator
主要研究者

Sara Farrag Ahmed Mohamed

Lecturer of Rheumatology and Rehabilitation

Assiut University

研究点 (1)

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