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

Recruiting

• Conditions: Systemic Sclerosis

• Registration Number: NCT07012655
• Lead Sponsor: Assiut University

Brief Summary

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.

Detailed Description

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.

Understanding the etiology and early phases of GI involvement, therefore, remains a high priority in SSc research. The aim would be to identify patients at high risk of developing progressive GI involvement, monitor disease activity, in the vessels or other relevant tissues, and intervene before the development of signifcant damage/dysfunction.

Bandini et al. showed how potentially the splanchnic vessels in SSc may be non-invasively investigated with abdominal US and color Doppler US, showing that some morphological and functional US parameters of mesenteric arteries of SSc patients are different from healthy controls defining a "bowel vasculopathy".

Abdominal ultrasound (US) is a unique tool that allows for the noninvasive assessment of the vasculature and major parts of the GI tract, including extra-intestinal features and splanchnic vessels as well as peripheral vessels.

Study Timeline

• Study Start: 2024-05-01
• Status Verified: 2025-06
• Study First Submitted: 2025-06-01
• Study First Submitted QC: 2025-06-01
• Last Update Submitted: 2025-06-01
• Study First Posted: 2025-06-10
• Last Update Posted: 2025-06-10
• Primary Completion: 2025-08-01
• Study Completion: 2025-09-01

Recruitment & Eligibility

• Status: RECRUITING
• Sex: All
• Target Recruitment: 50

Inclusion Criteria

• 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.

Exclusion Criteria

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

Study & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
Macro vascular involvement in systemic sclerosis patients	day 1	Assess the macro vascular involvement in SSc patients through an ultrasound (US) evaluation of radial and ulnar arteries and splanchnic vessels.

Trial Locations

Locations (1)

Assiut University hospital; 🇪🇬 Assiut, Egypt