Ireland
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Starting soon Observational

Assessment of GIT Vasculopathy in SSc and Its Multisystem Correlations

NCT07171437 · tracked via the Priya Life Science Egypt tracker
Sponsor
Esraa Moustafa Mohammed
Phase
Observational
Started
2025-10-01
Last updated
2025-09-12

Condition(s) studied

Systemic Sclerosis Associated GIT Vasculopathy

Investigational drug(s) / intervention(s)

Doppler ultra sound

Doppler ultra sound: \- Doppler Ultrasound (DUS) To evaluate the abdominal aorta and the 3 main splanchnic vessels: Celiac Trunk (CT) Superior Mesenteric Artery (SMA) Inferior Mesenteric Artery (IMA) An ultrasound examination will be performed after a fasting period of at least 8 hours by a single operator blinded to clinical features. For abdominal vessels, the following parameters were measured: caliber, thickness, echogenicity, peak systolic velocity (PSV), end diastolic velocity (EDV), reverse velocity (RV), mean velocity (MV), resistive index (RI), and pulsatility index (PI).

Study summary

* Evaluation of splanchnic vasculature, including arterial blood flow using Doppler ultrasound in patients with systemic sclerosis compared to healthy subjects.
* Correlation of Doppler findings of splanchnic vessels with GIT manifestations.
* Correlation of Doppler findings of splanchnic vessels with macrovascular affection (chest, cardiac, and renal), microvascular involvement (capillaroscopy findings), and autoantibodies (anti-SCL70 antibody and anti-centromere antibody).

Eligibility

Sex
ALL
Min age
18 Years
Max age
—
Healthy volunteers
No
Inclusion Criteria: 1. Adult patients aged 18 years or older. 2. Patients classified as systemic sclerosis (SSc) according to ACR/EULAR 2013 classification criteria. 3. Patients who consented to undergo Doppler ultrasound (DUS) assessment of the splanchnic vessels. Exclusion Criteria: 1. Patients younger than 18 years old. 2. Pregnancy or lactation. 3. Patients with overlapping autoimmune diseases (e.g., lupus, rheumatoid arthritis). 4. Patients with known gastrointestinal disorders not related to systemic sclerosis (e.g., inflammatory bowel disease, celiac disease). 5. Patients with a history of major gastrointestinal surgery (e.g., bowel resection). 6. Patients with diabetes mellitus (due to its independent effects on vascular flow). 7. Presence of severe comorbidities (e.g., end-stage renal disease, decompensated heart failure).

Primary outcome measure(s)

  • Evaluation of splanchnic vasculature, including arterial blood flow by Doppler ultrasound in SSc patients compared to healthy controls, and its correlation with GIT manifestations. — baseline

Trial sites (1)

FacilityCityRegionStatus
Assiut University, Assiut, 71111 Asyut Egypt
Official registry record

This page summarises publicly available registry data for informational purposes — not medical advice. Eligibility is determined by each study team; patients should discuss participation with their clinician.

View NCT07171437 on ClinicalTrials.gov ↗ ← All trials in Egypt