StrokeNCT05475080
Carotid Web and Stroke Registry.
An observational study of Stroke and Carotid Web, run by Fundació Institut de Recerca de l'Hospital de la Santa Creu i Sant Pau at 1 site in Spain.
Trial summary
Introduction: Carotid Web (CW) is a common cause of stroke in young patients with a high recurrence rate. The factors associated with recurrences and the appropriate treatment to prevent them are currently unknown. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Stroke, Carotid Web
- What is being tested?
- Antiplatelet Drug, Anticoagulant and Endovascular
- Type of treatment
- Surgery or procedure
- How many people
- 100 participants
- Where
- 1 siteSpain
- Study dates
- 15 Jul 2022to 15 Jul 2025
- How long will I take part?
- 6 Months
- 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 with ischemic stroke or TIA and an age > or = 18 years, in whom a CW is diagnosed during the etiological study, will be included. A CW will be defined by the presence of a focal and homogeneous intraluminal protrusion (shelf-like), without calcific component, located in the posterior or postero-lateral wall of the proximal internal carotid artery or carotid bulb. The diagnosis should be made by angioCT, angioMRI or arteriography. Both patients with a CW ipsilateral to the ischemic event and those with a CW unrelated to the ischemic event will be included.
Who may be able to join
- Patients with ischemic stroke or TIA and
- Age > or = 18 years.
- Carotid Web diagnosed by angioCT, angioMRI or arteriography.
- Consent to participate from patient or representative
Who cannot join
- No informed consent obtained
Trial locations and contacts
1 site in 1 country.
Joan Martí Fàbregas, PhD contact
Spain1 site, 1 recruiting
- Recruiting
Hospital de la Santa Creu i Sant Pau
Barcelona, 08041
Marina Guasch Jiménez, MD, +34680590776, mguasch@santpau.cat
About this study
Official title: Carotid Web and Stroke Registry. Clinical and Genetic Study. "Registro de Pacientes Con Carotid Web e Ictus. Estudio clínico y genético"
Introduction:
Carotid Web (CW) is a common cause of stroke in young patients with a high recurrence rate. The factors associated with recurrences and the appropriate treatment to prevent them are currently unknown.
Read more
Main objective:
To compare recurrences of ischemic stroke (cerebral infarction or transient ischemic attack) in patients with CW according to the preventive treatment.
Secondary objectives:
- To describe the frequency of recurrences in patients with stroke and CW.
- To compare the risk of complications, especially hemorrhagic complications, in patients with stroke and CW according to the type of preventive treatment given.
- To describe the clinical and radiological characteristics of CW and identify which are associated with recurrences.
- To detect genetic polymorphisms associated with the presence of CW in stroke patients.
Study design:
Multicenter, prospective registry of consecutive cases with ischemic stroke in which a Carotid Web is detected between 2022 and 2024.
All patients with ischemic stroke or transient ischemic attack and age > or = 18 years, in whom a Carotid Web is diagnosed, will be included. Demographic and clinical variables, genetic study (not mandatory), diagnostic methods of CW, reperfusion treatment and secondary prevention will be collected. During a minimum follow-up of six months, vascular events (stroke, transient ischemic accidents, cerebral hemorrhages) and treatments (antiplatelet therapy, anticoagulation, endarterectomy, endovascular therapy) will be collected.
Once the registry has been completed, the frequency of recurrences and the factors associated with them will be analyzed.
Study population:
Patients with ischemic stroke or transient ischemic attack in whom a Carotid Web is detected. It is estimated to obtain data from approximately 100 patients.
Variables:
Demographic, clinical (past medical history, stroke characteristics), radiological (diagnostic method of CW, morphological characteristics of CW), therapeutic (preventive treatment initiated) and prognostic variables will be collected. Recurrences in the form of stroke or transient ischemic attack (main variable) will be collected during a minimum follow-up of six months. Cerebral hemorrhages, mortality and therapeutic changes during follow-up will also be collected.
Ethical considerations:
This is an observational registry, with no changes in the management or treatment of the patients included, and with an anonymized data registry. Written informed consent will be requested from the patient or his/her representative for participation in the registry and for obtaining a blood sample for the genetic study.
- Conditions
- Stroke, Carotid Web
- Being tested
- Antiplatelet Drug, Anticoagulant, Endovascular, Surgery
- Medical subject headings
- Stroke
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Antiplatelet DrugDrug
Any antiplatelet drug or combination
AnticoagulantDrug
Any anticoagulante
EndovascularProcedure or surgery
Angioplasty +- stent
SurgeryProcedure or surgery
Endarterectomy
| Study group | Role | What they receive |
|---|---|---|
| Antiplatelet | Not described Receives: Drug: Antiplatelet Drug | |
| Anticoagulant | Not described Receives: Drug: Anticoagulant | |
| Endovascular | Not described Receives: Procedure: Endovascular | |
| Surgical (endarterectomy) | Not described Receives: Procedure: Surgery |
What is being measured
The primary outcome is the main question the study is designed to answer.
Ischemic Recurrences
Stroke or TIA
Measured: At least 6 months of follow-up
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted26 Jul 2022
- Study start15 Jul 2022
- Primary completion15 Jul 2024 (estimated)
- Study completion15 Jul 2025 (estimated)
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
- Prospective
- Enrolment
- 100 participants (estimated)
- Target duration
- 6 Months
Sponsor and investigators
- Lead sponsor
- Fundació Institut de Recerca de l'Hospital de la Santa Creu i Sant Pau
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05475080
- Sponsor's protocol ID
- IIBSP-CWI-2022-33
- Status last verified
- Jul 2022
- First submitted
- 22 Jul 2022
- Last updated
- 1 Aug 2022
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Yes
Study at a glance
From the registry record, last updated by the sponsor on 1 Aug 2022. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Carotid Web and Stroke Registry. Clinical and Genetic Study. "Registro de Pacientes Con Carotid Web e Ictus. Estudio clínico y genético"
- ClinicalTrials.gov ID
- NCT05475080
- Acronym / sponsor ID
- IIBSP-CWI-2022-33
- Conditions
- Stroke, Carotid Web
- Study type
- Observational
- Recruitment status
- Unknown status
- Enrolment
- 100 participants (estimated)
- Lead sponsor
- Fundació Institut de Recerca de l'Hospital de la Santa Creu i Sant PauUniversity, hospital or other
- Study start
- 15 Jul 2022 (actual)
- Primary completion
- 15 Jul 2024 (estimated)
- Study completion
- 15 Jul 2025 (estimated)
- First posted
- 26 Jul 2022 (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.
Introduction:
Carotid Web (CW) is a common cause of stroke in young patients with a high recurrence rate. The factors associated with recurrences and the appropriate treatment to prevent them are currently unknown.
Main objective:
To compare recurrences of ischemic stroke (cerebral infarction or transient ischemic attack) in patients with CW according to the preventive treatment.
Secondary objectives:
- To describe the frequency of recurrences in patients with stroke and CW.
- To compare the risk of complications, especially hemorrhagic complications, in patients with stroke and CW according to the type of preventive treatment given.
- To describe the clinical and radiological characteristics of CW and identify which are associated with recurrences.
- To detect genetic polymorphisms associated with the presence of CW in stroke patients.
Study design:
Multicenter, prospective registry of consecutive cases with ischemic stroke in which a Carotid Web is detected between 2022 and 2024.
All patients with ischemic stroke or transient ischemic attack and age > or = 18 years, in whom a Carotid Web is diagnosed, will be included. Demographic and clinical variables, genetic study (not mandatory), diagnostic methods of CW, reperfusion treatment and secondary prevention will be collected. During a minimum follow-up of six months, vascular events (stroke, transient ischemic accidents, cerebral hemorrhages) and treatments (antiplatelet therapy, anticoagulation, endarterectomy, endovascular therapy) will be collected.
Once the registry has been completed, the frequency of recurrences and the factors associated with them will be analyzed.
Study population:
Patients with ischemic stroke or transient ischemic attack in whom a Carotid Web is detected. It is estimated to obtain data from approximately 100 patients.
Variables:
Demographic, clinical (past medical history, stroke characteristics), radiological (diagnostic method of CW, morphological characteristics of CW), therapeutic (preventive treatment initiated) and prognostic variables will be collected. Recurrences in the form of stroke or transient ischemic attack (main variable) will be collected during a minimum follow-up of six months. Cerebral hemorrhages, mortality and therapeutic changes during follow-up will also be collected.
Ethical considerations:
This is an observational registry, with no changes in the management or treatment of the patients included, and with an anonymized data registry. Written informed consent will be requested from the patient or his/her representative for participation in the registry and for obtaining a blood sample for the genetic study.
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
- Target follow-up
- 6 Months
- Number of arms
- 4
| Arm | Type | Receives |
|---|---|---|
| Antiplatelet | – | Drug: Antiplatelet Drug |
| Anticoagulant | – | Drug: Anticoagulant |
| Endovascular | – | Procedure: Endovascular |
| Surgical (endarterectomy) | – | Procedure: Surgery |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- Patients with ischemic stroke or TIA and an age > or = 18 years, in whom a CW is diagnosed during the etiological study, will be included. A CW will be defined by the presence of a focal and homogeneous intraluminal protrusion (shelf-like), without calcific component, located in the posterior or postero-lateral wall of the proximal internal carotid artery or carotid bulb. The diagnosis should be made by angioCT, angioMRI or arteriography. Both patients with a CW ipsilateral to the ischemic event and those with a CW unrelated to the ischemic event will be included.
Key inclusion criteria (4 listed)
- Patients with ischemic stroke or TIA and
- Age > or = 18 years.
- Carotid Web diagnosed by angioCT, angioMRI or arteriography.
- Consent to participate from patient or representative
Key exclusion criteria (1 listed)
- No informed consent obtained
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 |
|---|---|---|
| Antiplatelet DrugAny antiplatelet drug or combination | Drug | Antiplatelet |
| AnticoagulantAny anticoagulante | Drug | Anticoagulant |
| EndovascularAngioplasty +- stent | Procedure or surgery | Endovascular |
| SurgeryEndarterectomy | Procedure or surgery | Surgical (endarterectomy) |
Primary outcome
Ischemic Recurrences
Time frame: At least 6 months of follow-up
Stroke or TIA
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 1 Aug 2022.
- Individual participant dataSharing planned: Yes
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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.
Joan Martí Fàbregas, PhD 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 Stroke and Carotid Web, run by Fundació Institut de Recerca de l'Hospital de la Santa Creu i Sant Pau at 1 site in Spain.
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 4 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 1 Aug 2022. 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 Spain. 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 Guasch Jiménez, MD (+34680590776, mguasch@santpau.cat), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Ischemic Recurrences (time frame: At least 6 months of follow-up). 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 1 Aug 2022; AzTrials last refreshed its copy on 29 Oct 2026.