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Clinical Trial Details — Status: Recruiting

Administrative data

NCT number NCT04738864
Other study ID # 17300548
Secondary ID
Status Recruiting
Phase N/A
First received
Last updated
Start date March 2021
Est. completion date August 2021

Study information

Verified date February 2021
Source Assiut University
Contact Esraa A Talaat, lecturer
Phone 01003314717
Email Esraa_ahmed@aun.edu.eg
Is FDA regulated No
Health authority
Study type Interventional

Clinical Trial Summary

Assessment of structural changes that occur in large extracranial and intracranial arteries in patients with Behcet's disease


Description:

Patients will be selected from Rheumatology and Rehabilitation inpatient and outpatient clinics in Assiute University Hospital Patients under 16 years old, patients with hyperlipidemia, hypertension, diabetes mellitus and all other risk factors affecting blood vessel intimal thickness will be excluded from the research. All patients and control groups underwent a complete extracranial and intracranial ultrasound assessment by 2 experienced neurovascular sonographers .The ultrasound examination was done at the Neurovascular Ultrasound Laboratory in the Neurology department, Assiut University hospitals using a color-coded duplex ultrasound device Philips HD5 (Philips Medical Systems, Nederland B.V.) for the carotid and vertebral arteries and for the intracranial arteries. Intimal medial thickness (IMT) of the common carotid artery (CCA), peak systolic velocities (PSVs) and end diastolic velocities (EDVs) were measured in the common, internal, and external carotid arteries (CCA, ICA, ECA) with L 3-12 MHz linear transducer probe and when stenosis was detected the velocities were measured at the maximally stenotic area. The intracranial arteries were evaluated in all patients with transcranial color-coded duplexsonography (TCCS) with the use of a low-frequency (2- to 5-MHz) phased-array probe through the transtemporal acoustic bone window. The middle cerebral artery (MCA), intracranial segment of vertebral artery (V4)and basilar artery (BA) were examined. Peak systolic velocity (PSV) and flow direction (antegrade or reversed) used for the diagnosis of any intracranial atherosclerotic disease (ICAD). The findings and the atherosclerotic changes in the extracranial and intracranial vessels were interpreted according to the internationally published data Data will be analyzed using the computer program SPSS


Recruitment information / eligibility

Status Recruiting
Enrollment 30
Est. completion date August 2021
Est. primary completion date June 2021
Accepts healthy volunteers Accepts Healthy Volunteers
Gender All
Age group N/A and older
Eligibility Inclusion Criteria: - patient more than 18 years old - All patients fulfill the modified International Criteria for Behçet's Disease Exclusion Criteria: - Patients under 16 years old, - patients with hyperlipidemia, hypertension, diabetes mellitus and all other risk factors affecting blood vessel intimal thickness

Study Design


Related Conditions & MeSH terms


Intervention

Diagnostic Test:
ultrasound
extracranial and intracranial ultrasound assessment

Locations

Country Name City State
Egypt Medicine Assiut

Sponsors (1)

Lead Sponsor Collaborator
Assiut University

Country where clinical trial is conducted

Egypt, 

Outcome

Type Measure Description Time frame Safety issue
Primary CNS vascular involving ultrasound of CNS vescle 6 mounth
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