StrokeNCT06058507
"Carotid Web Incidence and Radiological Classification, Determination of Its Relationship With Ischemic Stroke"
An observational study of Stroke and Transient Ischemic Attack, run by Suleyman Demirel University at 1 site in Turkey (Türkiye).
Trial summary
In our research, we aim to increase awareness on this issue by classifying the frequency of carotid webs and their radiological classification; Evaluating the clinical data and vascular risk factors of carotid web cases and determining their relationship with ischemic stroke and determining the measures that can be… Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Stroke, Transient Ischemic Attack, Carotid Artery Diseases
- What is being tested?
- CT angiography
- How many people
- 31 participants
- Where
- 1 siteTurkey (Türkiye)
- Study dates
- 19 Apr 2022to 20 Aug 2023
- 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 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Study population: Patients over 18 years of age who underwent carotid CTA and/or DSA imaging with the preliminary diagnosis of cerebrovascular disease and a carotid web was detected.
Who may be able to join
- Being over 18 years old
- Having a preliminary diagnosis of cerebrovascular disease
- Having carotid CTA and/or DSA imaging performed
Who cannot join
- Being under 18 years of age
- Patients who cannot undergo CTA and/or DSA imaging due to the risk of contrast material allergy or renal failure.
- Patients for whom consent for imaging cannot be obtained by the patient and their relatives and for whom CTA/DSA examination is not required in terms of etiology
Trial locations and contacts
1 site in 1 country.
About this study
Official title: "The Incidence of Carotid Web and Its Radiological Classification, Determination of Its Relationship With Ischemic Stroke by Evaluating the Clinical Data and Vascular Risk Factors of Carotid Web Cases"
In our research, we aim to increase awareness on this issue by classifying the frequency of carotid webs and their radiological classification; Evaluating the clinical data and vascular risk factors of carotid web cases and determining their relationship with ischemic stroke and determining the measures that can be taken for future optimal treatment.
We aimed to contribute to their approach.
Read the detailed description
Carotid web is a thin membrane-like tissue that extends from the wall to the lumen of the carotid artery bulb, identified radiologically. It is considered that stroke may be related to altered hemodynamics, blood stasis and fibrin-based clot embolization mechanisms in the distal carotid web. Radiologically, in DSA and CTA, there is a thin membrane-like intraluminal filling defect extending along the posterior carotid wall in oblique-sagittal sections and a corresponding defect in axial sections.
It is seen as a thin septum; There is no study on its classification in the literature. Determination of the incidence of carotid web, determination of its relationship with ischemic stroke / TİA, Facilitating distinctions such as dissection etc. by making radiological classification is important in terms of increasing awareness on this issue and early diagnosis. Demonstrating the relationship between carotid webs, which are shown as a cryptogenic cause of stroke, and vascular risk factors and taking protective measures against them will be effective in preventing strokes. In our research, we aim to increase awareness on this issue by classifying the frequency of carotid webs and their radiological classification; We aimed to evaluate the clinical data and vascular risk factors of carotid web cases, determine their relationship with ischemic stroke, and determine the precautions that can be taken to contribute to future optimal treatment approaches.
- Conditions
- Stroke, Transient Ischemic Attack, Carotid Artery Diseases
- Being tested
- CT angiography
- Keywords
- carotid web, ischemic stroke, transient ischemic atack
- Medical subject headings
- Stroke, Ischemic Attack, Transient, Carotid Artery Diseases, Ischemic Stroke
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
CT angiographyDiagnostic test
No intervention was made
| Study group | Role | What they receive |
|---|---|---|
| Patients with carotid web detected | Patients in whom carotid web was detected by examining carotid CTA images Receives: Diagnostic Test: CT angiography |
What is being measured
The primary outcome is the main question the study is designed to answer.
ischemic stroke
dysarthria, weakness, facial paralysis
Measured: 1 year
Secondary outcomes (1)
transient ischemic atack
temporary weakness and slurred speech
Measured: 1 year
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted28 Sep 2023
- Study start19 Apr 2022
- Primary completion20 Jul 2023
- Study completion20 Aug 2023
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for StrokeStudies of the same condition, open and under way.
- 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
- Retrospective
- Enrolment
- 31 participants (actual)
Sponsor and investigators
- Lead sponsor
- Suleyman Demirel University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Ekin Öykü Baylam Yirmibeş, Suleyman Demirel University
- Investigators
- ekin EB baylam yirmibeş, Principal investigator, Suleyman Demirel University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06058507
- Sponsor's protocol ID
- SDUWEB
- Status last verified
- Sep 2023
- First submitted
- 21 Sep 2023
- Last updated
- 28 Sep 2023
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 28 Sep 2023. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- "The Incidence of Carotid Web and Its Radiological Classification, Determination of Its Relationship With Ischemic Stroke by Evaluating the Clinical Data and Vascular Risk Factors of Carotid Web Cases"
- ClinicalTrials.gov ID
- NCT06058507
- Acronym / sponsor ID
- SDUWEB
- Conditions
- Stroke, Transient Ischemic Attack, Carotid Artery Diseases
- Keywords
- carotid web, ischemic stroke, transient ischemic atack
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 31 participants (actual)
- Lead sponsor
- Suleyman Demirel UniversityUniversity, hospital or other
- Study start
- 19 Apr 2022 (actual)
- Primary completion
- 20 Jul 2023 (actual)
- Study completion
- 20 Aug 2023 (actual)
- First posted
- 28 Sep 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.
In our research, we aim to increase awareness on this issue by classifying the frequency of carotid webs and their radiological classification; Evaluating the clinical data and vascular risk factors of carotid web cases and determining their relationship with ischemic stroke and determining the measures that can be taken for future optimal treatment.
We aimed to contribute to their approach.
Detailed description
Carotid web is a thin membrane-like tissue that extends from the wall to the lumen of the carotid artery bulb, identified radiologically. It is considered that stroke may be related to altered hemodynamics, blood stasis and fibrin-based clot embolization mechanisms in the distal carotid web. Radiologically, in DSA and CTA, there is a thin membrane-like intraluminal filling defect extending along the posterior carotid wall in oblique-sagittal sections and a corresponding defect in axial sections.
It is seen as a thin septum; There is no study on its classification in the literature. Determination of the incidence of carotid web, determination of its relationship with ischemic stroke / TİA, Facilitating distinctions such as dissection etc. by making radiological classification is important in terms of increasing awareness on this issue and early diagnosis. Demonstrating the relationship between carotid webs, which are shown as a cryptogenic cause of stroke, and vascular risk factors and taking protective measures against them will be effective in preventing strokes. In our research, we aim to increase awareness on this issue by classifying the frequency of carotid webs and their radiological classification; We aimed to evaluate the clinical data and vascular risk factors of carotid web cases, determine their relationship with ischemic stroke, and determine the precautions that can be taken to contribute to future optimal treatment approaches.
Study design
- Observational model
- Cohort
- Time perspective
- Retrospective
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Patients with carotid web detected | – | Diagnostic Test: CT angiographyPatients in whom carotid web was detected by examining carotid CTA images |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- Patients over 18 years of age who underwent carotid CTA and/or DSA imaging with the preliminary diagnosis of cerebrovascular disease and a carotid web was detected.
Key inclusion criteria (3 listed)
- Being over 18 years old
Key exclusion criteria (3 listed)
- Being under 18 years of age
- Patients who cannot undergo CTA and/or DSA imaging due to the risk of contrast material allergy or renal failure.
- Patients for whom consent for imaging cannot be obtained by the patient and their relatives and for whom CTA/DSA examination is not required in terms of etiology
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 |
|---|---|---|
| CT angiographyNo intervention was made | Diagnostic test | Patients with carotid web detected |
Primary outcome
ischemic stroke
Time frame: 1 year
dysarthria, weakness, facial paralysis
1 secondary outcome
transient ischemic atack
Time frame: 1 year
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 28 Sep 2023.
- Individual participant dataSharing planned: No
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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.
ekin EB baylam yirmibeş principal investigator
Suleyman Demirel University
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 Stroke and Transient Ischemic Attack, run by Suleyman Demirel University at 1 site in Turkey (Türkiye).
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 3 inclusion and 3 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: finished, as of the sponsor's last update on 28 Sep 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 Turkey (Türkiye). 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?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
ischemic stroke (time frame: 1 year). 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 28 Sep 2023.