Collateral Circulation in Acute Ischemic Stroke With Large Vessel Occlusion

NCT ID: NCT04882657

Last Updated: 2021-05-12

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

700 participants

Study Classification

OBSERVATIONAL

Study Start Date

2021-06-01

Study Completion Date

2022-12-31

Brief Summary

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Prospective multicenter study of consecutive patients with acute ischemic stroke and large intracranial vessel occlusion in which a thorough and systematic evaluation of all variables that may be related to the degree of collateral circulation is performed.

Detailed Description

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Introduction. In patients with an acute ischemic stroke due to a large-vessel intracranial occlusion (LVO), the status of the colateral circulation (CC) is related to clinical outcome and to the success of mechanical thrombectomy. However, CC is highly variable from patient to patient.

Methods. An observational, prospective, multicenter study of 700 consecutive patients with acute ischemic stroke and a LVO. Factors to be evaluated: 1) Modifiable: Vascular risk factors, blood analysis, prior medications, vital constants (with emphasis on continuous blood pressure monitoring), head position, metrics (time to admission, Computed tomography (CT), groin puncture, end of procedure), 2) Non-modifiable: age, sex, completeness of Circle of Willis, etiology, type of mechanical thrombectomy, plasma biomarkers, genetic/epigenetic factors (a discovery phase with GWAs study and a replication phase). CC grade will be assessed by the ASITN/SIR collateral score from CT-angiography (CTA) and the Digital substraction angiography (DSA, when performed). Statistics: bivariate analyses and a logistic regression to predict CC grade (poor versus good) and CC persistence comparing CTA with DSA (4 possibilities: poor-poor, poor-good, good-poor, good-good).

Expected results. Our study may find markers of the CC status, facilitate the design of clinical trials to improve CC grade, may find new therapeutic targets and new treatments to enhance the beneficial effects of mechanical thrombectomy.

Conditions

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Stroke, Ischemic Stroke, Acute Collateral Circulation, Any Site

Study Design

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Observational Model Type

COHORT

Study Time Perspective

PROSPECTIVE

Eligibility Criteria

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Inclusion Criteria

* Patients with acute ischemic stroke.
* Large vessel occlusion of an intracranial internal artery: M1, M2 or TICA. (terminal intracranial carotid artery), as demonstrated by CTA.
* CTA performed within the first 24 hours after stroke onset. Patients with wake-up stroke are included.
* A previous modified Rankin Scale score of 0 to 3.
* The patient or a legal representative signs a written consent to participate.

Exclusion Criteria

* More than 24 hours from last been known to be well.
* Occlusion of other arterial segments (vertebrobasilar circulation, A1, P1, M3, M4).
* Age below 18 years.
Minimum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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Instituto de Salud Carlos III

OTHER_GOV

Sponsor Role collaborator

Complejo Hospitalario Universitario de Albacete

OTHER

Sponsor Role collaborator

Hospital de Cruces

OTHER

Sponsor Role collaborator

Hospital Clínico Universitario de Valladolid

OTHER

Sponsor Role collaborator

Hospitales Universitarios Virgen del Rocío

OTHER

Sponsor Role collaborator

Fundación de Investigación Biomédica - Hospital Universitario de La Princesa

OTHER

Sponsor Role collaborator

Hospital Universitario La Paz

OTHER

Sponsor Role collaborator

Hospital del Mar

OTHER

Sponsor Role collaborator

Hospital Arnau de Vilanova

OTHER

Sponsor Role collaborator

Complexo Hospitalario Universitario de A Coruña

OTHER

Sponsor Role collaborator

Red de Enfermedades Vasculares Cerebrales INVICTUS PLUS (Rd1600190024)

UNKNOWN

Sponsor Role collaborator

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

Central Contacts

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Joan Martí-Fàbregas, MD, PhD

Role: CONTACT

+34935565986

Daniel Guisado-Alonso, MD

Role: CONTACT

+34935565986

Other Identifiers

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IIBSP-COL-2019-64

Identifier Type: -

Identifier Source: org_study_id

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