Neuro-ultrasound Assessment in Behcet's Disease

February 3, 2021 updated by: Esraa Ahmed Talaat, Assiut University

The Effect of Behcet's Disease on Cerebrovascular Circulation

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

Study Overview

Status

Unknown

Conditions

Intervention / Treatment

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

Study Type

Interventional

Enrollment (Anticipated)

30

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

Study Contact Backup

Study Locations

  • Egypt
      • Assiut, Egypt, 71515
        • Recruiting
        • Medicine
        • Contact:

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

  • ADULT
  • OLDER_ADULT
  • CHILD

Accepts Healthy Volunteers

Yes

Genders Eligible for Study

All

Description

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 Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: DIAGNOSTIC
  • Allocation: RANDOMIZED
  • Interventional Model: PARALLEL
  • Masking: SINGLE

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
EXPERIMENTAL: behcet's disease patient
patient who presented with manifestation of behcet disease
Diagnostic test: ultrasound
extracranial and intracranial ultrasound assessment
EXPERIMENTAL: Healthy people
healthy control people
Diagnostic test: ultrasound
extracranial and intracranial ultrasound assessment

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
CNS vascular involving
Time Frame: 6 mounth
ultrasound of CNS vescle
6 mounth

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Assiut University

Investigators

  • Study Chair: Esraa A Talaat, Lecturer, Assiut University

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (ANTICIPATED)

March 1, 2021

Primary Completion (ANTICIPATED)

June 1, 2021

Study Completion (ANTICIPATED)

August 1, 2021

Study Registration Dates

First Submitted

January 31, 2021

First Submitted That Met QC Criteria

February 3, 2021

First Posted (ACTUAL)

February 4, 2021

Study Record Updates

Last Update Posted (ACTUAL)

February 4, 2021

Last Update Submitted That Met QC Criteria

February 3, 2021

Last Verified

February 1, 2021

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

  • 17300548

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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