Carotid Web and Stroke Registry.

NCT05475080 | Unknown

• 1 other identifier: IIBSP-CWI-2022-33
• Study Type: observational
• Target: 100
• Locations: 1 country
• Sites: 1

Brief 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. 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

Outcome Measures

Primary Outcomes (1)

• Ischemic Recurrences

  Stroke or TIA

  At least 6 months of follow-up

Study Arms (4)

Antiplatelet

Drug: Antiplatelet Drug

Anticoagulant

Drug: Anticoagulant

Endovascular

Procedure: Endovascular

Surgical (endarterectomy)

Procedure: Surgery

Interventions

Antiplatelet Drug DRUG

Any antiplatelet drug or combination

Antiplatelet

Anticoagulant DRUG

Any anticoagulante

Anticoagulant

Endovascular PROCEDURE

Angioplasty +- stent

Endovascular

Surgery PROCEDURE

Endarterectomy

Surgical (endarterectomy)

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)
• Sampling Method: Non-Probability Sample

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.

You may qualify if:

• 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

You may not qualify if:

• No informed consent obtained

Sponsors & Collaborators

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

Study Sites (1)

Hospital de la Santa Creu i Sant Pau

Barcelona, 08041, Spain

RECRUITING

MeSH Terms

Conditions

Stroke

Interventions

Platelet Aggregation Inhibitors; Anticoagulants; Surgical Procedures, Operative

Condition Hierarchy (Ancestors)

Cerebrovascular Disorders; Brain Diseases; Central Nervous System Diseases; Nervous System Diseases; Vascular Diseases; Cardiovascular Diseases

Intervention Hierarchy (Ancestors)

Hematologic Agents; Therapeutic Uses; Pharmacologic Actions; Chemical Actions and Uses

Central Study Contacts

Marina Guasch Jiménez, MD

CONTACT

+34680590776; mguasch@santpau.cat

Joan Martí Fàbregas, PhD

CONTACT

jmarti@santpau.cat

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: PROSPECTIVE
• Target Duration: 6 Months
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: July 22, 2022
• First Posted: July 26, 2022
• Study Start: July 15, 2022
• Primary Completion: July 15, 2024
• Study Completion: July 15, 2025
• Last Updated: August 1, 2022

Record last verified: 2022-07

Data Sharing

• IPD Sharing: Will share

Locations

ES (1)