Behcet SyndromeNCT04738864
Neuro-ultrasound Assessment in Behcet's Disease
A study testing ultrasound in people with Behcet Syndrome, run by Assiut University at 1 site in Egypt.
Trial summary
Assessment of structural changes that occur in large extracranial and intracranial arteries in patients with Behcet's disease Read more about this study
- Who is it for?
- Any ageHealthy volunteers can take part
- Conditions the study is for
- Behcet Syndrome
- What is being tested?
- ultrasound
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 30 participants
- Where
- 1 siteEgypt
- Study dates
- Mar 2021to Aug 2021
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages Any age
- All sexes
- Healthy volunteers accepted
- Child, Adult, Older adult
Who may be able to join
- patient more than 18 years old
- All patients fulfill the modified International Criteria for Behçet's Disease
Who cannot join
- Patients under 16 years old,
- patients with hyperlipidemia, hypertension, diabetes mellitus and all other risk factors affecting blood vessel intimal thickness
Trial locations and contacts
1 site in 1 country.
Egypt1 site, 1 recruiting
- Recruiting
Medicine
Asyut, 71515
vice V president, proffesor, 00208822080150, Yp_grad@aun.edu.eg
About this study
Official title: 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
Read the 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
- Conditions
- Behcet Syndrome
- Being tested
- ultrasound
- Medical subject headings
- Behcet Syndrome
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
ultrasoundDiagnostic test
extracranial and intracranial ultrasound assessment
| Study group | Role | What they receive |
|---|---|---|
| behcet's disease patient | Experimental | patient who presented with manifestation of behcet disease Receives: Diagnostic Test: ultrasound |
| Healthy people | Experimental | healthy control people Receives: Diagnostic Test: ultrasound |
What is being measured
The primary outcome is the main question the study is designed to answer.
CNS vascular involving
ultrasound of CNS vescle
Measured: 6 mounth
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted4 Feb 2021
- Study startMar 2021 (estimated)
- Primary completionJun 2021 (estimated)
- Study completionAug 2021 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Behcet SyndromeStudies of the same condition, open and under way.
- More trials run by Assiut UniversityThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Diagnosis
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind
- Who is masked
- Participant
- Enrolment
- 30 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Assiut University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Esraa Ahmed Talaat, Assiut University
- Investigators
- Esraa A Talaat, Lecturer, Study chair, Assiut University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04738864
- Sponsor's protocol ID
- 17300548
- Status last verified
- Feb 2021
- First submitted
- 31 Jan 2021
- Last updated
- 4 Feb 2021
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 4 Feb 2021. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- The Effect of Behcet's Disease on Cerebrovascular Circulation
- ClinicalTrials.gov ID
- NCT04738864
- Acronym / sponsor ID
- 17300548
- Conditions
- Behcet Syndrome
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 30 participants (estimated)
- Lead sponsor
- Assiut UniversityUniversity, hospital or other
- Study start
- Mar 2021 (estimated)
- Primary completion
- Jun 2021 (estimated)
- Study completion
- Aug 2021 (estimated)
- First posted
- 4 Feb 2021 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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
Study design
- Primary purpose
- Diagnosis
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (participant)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| behcet's disease patient | Experimental | Diagnostic Test: ultrasoundpatient who presented with manifestation of behcet disease |
| Healthy people | Experimental | Diagnostic Test: ultrasoundhealthy control people |
Who may qualify
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Child, Adult, Older adult
Key inclusion criteria (2 listed)
- patient more than 18 years old
- All patients fulfill the modified International Criteria for Behçet's Disease
Key exclusion criteria (2 listed)
- Patients under 16 years old,
- patients with hyperlipidemia, hypertension, diabetes mellitus and all other risk factors affecting blood vessel intimal thickness
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| ultrasoundextracranial and intracranial ultrasound assessment | Diagnostic test | Healthy people, behcet's disease patient |
Primary outcome
CNS vascular involving
Time frame: 6 mounth
ultrasound of CNS vescle
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 4 Feb 2021.
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Corticotropin for Behçet's Disease: A Multicenter Randomized Controlled TrialAcronym.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Esraa A Talaat, Lecturer study chair
Assiut University
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing ultrasound in people with Behcet Syndrome, run by Assiut University at 1 site in Egypt.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 2 inclusion and 2 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: status not confirmed, as of the sponsor's last update on 4 Feb 2021. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Egypt. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Esraa A Talaat, lecturer (01003314717 ext. 0882413177, Esraa_ahmed@aun.edu.eg), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
CNS vascular involving (time frame: 6 mounth). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 4 Feb 2021.