Neuro-ultrasound Assessment in Behcet's Disease
Primary Purpose
Behcet Syndrome
Status
Unknown status
Phase
Not Applicable
Locations
Egypt
Study Type
Interventional
Intervention
ultrasound
Sponsored by
About this trial
This is an interventional diagnostic trial for Behcet Syndrome
Eligibility Criteria
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
Sites / Locations
- MedicineRecruiting
Arms of the Study
Arm 1
Arm 2
Arm Type
Experimental
Experimental
Arm Label
behcet's disease patient
Healthy people
Arm Description
patient who presented with manifestation of behcet disease
healthy control people
Outcomes
Primary Outcome Measures
CNS vascular involving
ultrasound of CNS vescle
Secondary Outcome Measures
Full Information
1. Study Identification
Unique Protocol Identification Number
NCT04738864
Brief Title
Neuro-ultrasound Assessment in Behcet's Disease
Official Title
The Effect of Behcet's Disease on Cerebrovascular Circulation
Study Type
Interventional
2. Study Status
Record Verification Date
February 2021
Overall Recruitment Status
Unknown status
Study Start Date
March 2021 (Anticipated)
Primary Completion Date
June 2021 (Anticipated)
Study Completion Date
August 2021 (Anticipated)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Assiut University
4. Oversight
Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
No
5. Study Description
Brief Summary
Assessment of structural changes that occur in large extracranial and intracranial arteries in patients with Behcet's disease
Detailed 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
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Behcet Syndrome
7. Study Design
Primary Purpose
Diagnostic
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
Participant
Allocation
Randomized
Enrollment
30 (Anticipated)
8. Arms, Groups, and Interventions
Arm Title
behcet's disease patient
Arm Type
Experimental
Arm Description
patient who presented with manifestation of behcet disease
Arm Title
Healthy people
Arm Type
Experimental
Arm Description
healthy control people
Intervention Type
Diagnostic Test
Intervention Name(s)
ultrasound
Intervention Description
extracranial and intracranial ultrasound assessment
Primary Outcome Measure Information:
Title
CNS vascular involving
Description
ultrasound of CNS vescle
Time Frame
6 mounth
10. Eligibility
Sex
All
Accepts Healthy Volunteers
Accepts Healthy Volunteers
Eligibility Criteria
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
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Esraa A Talaat, lecturer
Phone
01003314717
Ext
0882413177
Email
Esraa_ahmed@aun.edu.eg
First Name & Middle Initial & Last Name or Official Title & Degree
Shady M Safwat, Lecturer
Phone
01008763141
Email
Shadysafwt@yahoo.com
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Esraa A Talaat, Lecturer
Organizational Affiliation
Assiut University
Official's Role
Study Chair
Facility Information:
Facility Name
Medicine
City
Assiut
ZIP/Postal Code
71515
Country
Egypt
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
vice V president, proffesor
Phone
00208822080150
Email
Yp_grad@aun.edu.eg
12. IPD Sharing Statement
Learn more about this trial
Neuro-ultrasound Assessment in Behcet's Disease
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