Carotid Web and Stroke Registry.

NCT ID: NCT05475080

Last Updated: 2022-08-01

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

UNKNOWN

Total Enrollment

100 participants

Study Classification

OBSERVATIONAL

Study Start Date

2022-07-15

Study Completion Date

2025-07-15

Brief Summary

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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.

Detailed Description

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Conditions

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Stroke Carotid Web

Study Design

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Observational Model Type

COHORT

Study Time Perspective

PROSPECTIVE

Study Groups

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Antiplatelet

Antiplatelet Drug

Intervention Type DRUG

Any antiplatelet drug or combination

Anticoagulant

Anticoagulant

Intervention Type DRUG

Any anticoagulante

Endovascular

Endovascular

Intervention Type PROCEDURE

Angioplasty +- stent

Surgical (endarterectomy)

Surgery

Intervention Type PROCEDURE

Endarterectomy

Interventions

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Antiplatelet Drug

Any antiplatelet drug or combination

Intervention Type DRUG

Anticoagulant

Any anticoagulante

Intervention Type DRUG

Endovascular

Angioplasty +- stent

Intervention Type PROCEDURE

Surgery

Endarterectomy

Intervention Type PROCEDURE

Eligibility Criteria

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Inclusion Criteria

* 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

Exclusion Criteria

* No informed consent obtained
Minimum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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Fundació Institut de Recerca de l'Hospital de la Santa Creu i Sant Pau

OTHER

Sponsor Role lead

Responsible Party

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Responsibility Role SPONSOR

Locations

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Hospital de la Santa Creu i Sant Pau

Barcelona, , Spain

Site Status RECRUITING

Countries

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Spain

Central Contacts

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Marina Guasch Jiménez, MD

Role: CONTACT

+34680590776

Joan Martí Fàbregas, PhD

Role: CONTACT

Facility Contacts

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Marina Guasch Jiménez, MD

Role: primary

+34680590776

Other Identifiers

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IIBSP-CWI-2022-33

Identifier Type: -

Identifier Source: org_study_id

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