Anatomical Variants of Dural Sinuses by MRVNCT06120010
Prevalence of Anatomical Variants of Dural Sinuses by MRV Evaluation in Sohag
An observational study of Anatomical Variants of Dural Sinuses by MRV, run by Sohag University at 1 site in Egypt.
Trial summary
The purpose of this study is to use the MRV to depict the prevalence of anatomical variants of dural venous sinuses in Sohag population, which can help to avoid potenital pitfalls in the diagnosis of dural venous sinus thrombosis, venous infarcts and venous hemorrhage. Read more about this study
- Who is it for?
- Any age, women only
- Conditions the study is for
- Anatomical Variants of Dural Sinuses by MRV
- What is being tested?
- MRI
- Type of treatment
- Medical device
- How many people
- 169 participants
- Where
- 1 siteEgypt
- Study dates
- 30 Sep 2023to 30 Jun 2024
- Phase
- Observational
- 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
- Women only
- Child, Adult, Older adult
Study population: Sohag by nationality and residence, male or female by sex, having normal cerebral MRV reported and consented to participate in the research work will be included in this research.
Who may be able to join
- Sohag by nationality and residence, male or female by sex, having normal cerebral MRV reported and consented to participate in the research work will be included in this research.
Who cannot join
- Having the diagnosis of cerebral venous sinus thrombosis, congential or acquired intracranial abnormalities, ischemic or hemorrhagic stroke, intracranial hypertension, intracranial space occuping lesion, and previous head injury or neurosurgery, also patients with absolute or relative contraindications for imaging including claustrophobia, metallic implants, pacemaker and prosthetic heart valves for MRI.
Trial locations and contacts
1 site in 1 country.
Mohamed Th Mahmoud, professor contact
Egypt1 site, 1 recruiting
- Recruiting
Sohag university Hospital
Sohag, Sohag
Magdy M Amin, professor
About this study
The purpose of this study is to use the MRV to depict the prevalence of anatomical variants of dural venous sinuses in Sohag population, which can help to avoid potenital pitfalls in the diagnosis of dural venous sinus thrombosis, venous infarcts and venous hemorrhage.
- Being tested
- MRI
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
MRIDevice
To detect prevalence of anatomical variants of dural sinuses by MRV
What is being measured
The primary outcome is the main question the study is designed to answer.
Prevalence of anatomical variants of dural sinuses in Sohag population
Number of anatomical variants of dural sinuses by MRV evaluation in Sohag
Measured: 8 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted7 Nov 2023
- Study start30 Sep 2023
- Primary completion30 Jun 2024 (estimated)
- Study completion30 Jun 2024 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (4)Papers the sponsor has linked to this study.
- Other trials for Anatomical Variants of Dural Sinuses by MRVStudies of the same condition, open and under way.
- More trials run by Sohag 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
- Observational
- Observational model
- Cohort
- Time perspective
- Cross-sectional
- Enrolment
- 169 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Sohag University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Marina Makram Sabah, Sohag University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06120010
- Sponsor's protocol ID
- Soh-Med-23-10-01MS
- Status last verified
- Oct 2023
- First submitted
- 24 Oct 2023
- Last updated
- 7 Nov 2023
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Undecided
Publications
van Dam LF, van Walderveen MAA, Kroft LJM, Kruyt ND, Wermer MJH, van Osch MJP, Huisman MV, Klok FA. Current imaging modalities for diagnosing cerebral vein thrombosis - A critical review. Thromb Res. 2020 May;189:132-139. doi: 10.1016/j.thromres.2020.03.011. Epub 2020 Mar 19.
PubMed 32220779Leach JL, Fortuna RB, Jones BV, Gaskill-Shipley MF. Imaging of cerebral venous thrombosis: current techniques, spectrum of findings, and diagnostic pitfalls. Radiographics. 2006 Oct;26 Suppl 1:S19-41; discussion S42-3. doi: 10.1148/rg.26si055174.
PubMed 17050515Cure JK, Van Tassel P, Smith MT. Normal and variant anatomy of the dural venous sinuses. Semin Ultrasound CT MR. 1994 Dec;15(6):499-519. doi: 10.1016/s0887-2171(05)80019-8.
PubMed 7880564Tubbs RS, Bosmia AN, Shoja MM, Loukas M, Cure JK, Cohen-Gadol AA. The oblique occipital sinus: a review of anatomy and imaging characteristics. Surg Radiol Anat. 2011 Nov;33(9):747-9. doi: 10.1007/s00276-011-0831-9. Epub 2011 May 29.
PubMed 21626273
Study at a glance
From the registry record, last updated by the sponsor on 7 Nov 2023. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Prevalence of Anatomical Variants of Dural Sinuses by MRV Evaluation in Sohag
- ClinicalTrials.gov ID
- NCT06120010
- Acronym / sponsor ID
- Soh-Med-23-10-01MS
- Study type
- Observational
- Recruitment status
- Unknown status
- Enrolment
- 169 participants (estimated)
- Lead sponsor
- Sohag UniversityUniversity, hospital or other
- Study start
- 30 Sep 2023 (actual)
- Primary completion
- 30 Jun 2024 (estimated)
- Study completion
- 30 Jun 2024 (estimated)
- First posted
- 7 Nov 2023 (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.
The purpose of this study is to use the MRV to depict the prevalence of anatomical variants of dural venous sinuses in Sohag population, which can help to avoid potenital pitfalls in the diagnosis of dural venous sinus thrombosis, venous infarcts and venous hemorrhage.
Study design
- Observational model
- Cohort
- Time perspective
- Cross-sectional
Who may qualify
- Sex
- Female only
- Age groups
- Child, Adult, Older adult
- Study population
- Sohag by nationality and residence, male or female by sex, having normal cerebral MRV reported and consented to participate in the research work will be included in this research.
Key inclusion criteria (1 listed)
- Sohag by nationality and residence, male or female by sex, having normal cerebral MRV reported and consented to participate in the research work will be included in this research.
Key exclusion criteria (1 listed)
- Having the diagnosis of cerebral venous sinus thrombosis, congential or acquired intracranial abnormalities, ischemic or hemorrhagic stroke, intracranial hypertension, intracranial space occuping lesion, and previous head injury or neurosurgery, also patients with absolute or relative contraindications for imaging including claustrophobia, metallic implants, pacemaker and prosthetic heart valves for MRI.
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 |
|---|---|---|
| MRITo detect prevalence of anatomical variants of dural sinuses by MRV | Device | – |
Primary outcome
Prevalence of anatomical variants of dural sinuses in Sohag population
Time frame: 8 months
Number of anatomical variants of dural sinuses by MRV evaluation in Sohag
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 7 Nov 2023.
- Background: PubMed 32220779van Dam LF, van Walderveen MAA, Kroft LJM, Kruyt ND, Wermer MJH, van Osch MJP, Huisman MV, Klok FA. Current imaging modalities for diagnosing cerebral vein thrombosis - A critical review. Thromb Res. 2020 May;189:132-139. doi: 10.1016/j.thromres.2020.03.011. Epub 2020 Mar 19.
- Background: PubMed 17050515Leach JL, Fortuna RB, Jones BV, Gaskill-Shipley MF. Imaging of cerebral venous thrombosis: current techniques, spectrum of findings, and diagnostic pitfalls. Radiographics. 2006 Oct;26 Suppl 1:S19-41; discussion S42-3. doi: 10.1148/rg.26si055174.
- Background: PubMed 7880564Cure JK, Van Tassel P, Smith MT. Normal and variant anatomy of the dural venous sinuses. Semin Ultrasound CT MR. 1994 Dec;15(6):499-519. doi: 10.1016/s0887-2171(05)80019-8.
- Background: PubMed 21626273Tubbs RS, Bosmia AN, Shoja MM, Loukas M, Cure JK, Cohen-Gadol AA. The oblique occipital sinus: a review of anatomy and imaging characteristics. Surg Radiol Anat. 2011 Nov;33(9):747-9. doi: 10.1007/s00276-011-0831-9. Epub 2011 May 29.
- Individual participant dataSharing planned: Undecided
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.
Mohamed Th Mahmoud, professor contact
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Anatomical Variants of Dural Sinuses by MRV, run by Sohag 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 1 inclusion and 1 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 7 Nov 2023. 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 Marina M Sabah, resident (01201796003, marinamakram@med.sohag.edu.eg), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Prevalence of anatomical variants of dural sinuses in Sohag population (time frame: 8 months). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT06120010, which also lists 4 linked publications.
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 7 Nov 2023.