Carotid Web and Stroke Registry.

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.

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 Overview

• Status: Recruiting
• Conditions: Stroke; Carotid Web
• Intervention / Treatment: Drug: Antiplatelet Drug; Drug: Anticoagulant; Procedure: Endovascular; Procedure: Surgery

• Study Type: Observational
• Enrollment (Anticipated): 100

Contacts and Locations

• Study Contact: Name: Marina Guasch Jiménez, MD; Phone Number: +34680590776; Email: mguasch@santpau.cat
• Study Contact Backup: Name: Joan Martí Fàbregas, PhD; Email: jmarti@santpau.cat

Study Locations

• Spain
  • Barcelona, Spain, 08041
    • Recruiting
    • Hospital de la Santa Creu i Sant Pau
    • Contact: Marina Guasch Jiménez, MD; Phone Number: +34680590776; Email: mguasch@santpau.cat

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 16 years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

• 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.

Description

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

Study Plan

How is the study designed?

Design Details

• Observational Models: Cohort
• Time Perspectives: Prospective

Number of groups / cohorts

4

Cohorts and Interventions

Group / Cohort	Intervention / Treatment
Antiplatelet	Drug: Antiplatelet Drug; Any antiplatelet drug or combination
Anticoagulant	Drug: Anticoagulant; Any anticoagulante
Endovascular	Procedure: Endovascular; Angioplasty +- stent
Surgical (endarterectomy)	Procedure: Surgery; Endarterectomy

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Ischemic Recurrences	Stroke or TIA	At least 6 months of follow-up

Collaborators and Investigators

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

Study record dates

Study Major Dates

• Study Start (Actual): July 15, 2022
• Primary Completion (Anticipated): July 15, 2024
• Study Completion (Anticipated): July 15, 2025

Study Registration Dates

• First Submitted: July 22, 2022
• First Submitted That Met QC Criteria: July 22, 2022
• First Posted (Actual): July 26, 2022

Study Record Updates

• Last Update Posted (Actual): August 1, 2022
• Last Update Submitted That Met QC Criteria: July 28, 2022
• Last Verified: July 1, 2022

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Cardiovascular Diseases; Vascular Diseases; Cerebrovascular Disorders; Brain Diseases; Central Nervous System Diseases; Nervous System Diseases; Stroke; Anticoagulants; Platelet Aggregation Inhibitors
• Other Study ID Numbers: IIBSP-CWI-2022-33

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: Yes

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No