NCT05475080

Carotid Web and Stroke Registry.

Status unknown Last updated 1 August 2022

What this trial tests

trial testing Antiplatelet Drug in Stroke in 100 participants. Status unknown.

Timeline

15 July 2022

Primary endpoint
15 July 2024

15 July 2025

Quick facts

Lead sponsor	Fundació Institut de Recerca de l'Hospital de la Santa Creu i Sant Pau
Status	Status unknown
Study type	OBSERVATIONAL
Enrollment	100
Start date	15 July 2022
Primary completion	15 July 2024
Estimated completion	15 July 2025
Sites	1 location across Spain

Drugs / interventions tested

• Antiplatelet Drug (antiplatelet-drug) — full drug profile →
• Anticoagulant — full drug profile →
• Endovascular
• Surgery

Conditions studied

• Stroke — all drugs for Stroke →
• Carotid Web — all drugs for Carotid Web →

Sponsor

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

Who can join

18 and older, any sex, with Stroke or Carotid Web. Patients with the condition only — healthy volunteers not accepted.

Sponsor's own description

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.

Publications & conference data

No peer-reviewed publications indexed yet for this trial.