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Collateral Circulation in Acute Ischemic Stroke With Large Vessel Occlusion

Collateral Circulation (Collaterome) in Acute Ischemic Stroke With Large Vessel Occlusion: A Study of Clinical, Radiological, Plasma and Genetic Factors.

Status
UNKNOWN
Phases
Unknown
Study type
Observational
Source
ClinicalTrials.gov
Registry ID
NCT04882657
Acronym
COLISEUM
Enrollment
700
Registered
2021-05-12
Start date
2021-06-01
Completion date
2022-12-31
Last updated
2021-05-12

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Collateral Circulation, Any Site, Stroke, Acute, Stroke, Ischemic

Keywords

Collateral Circulation, Ischemic Stroke, Large Vessel Occlusion

Brief summary

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

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.

Interventions

None listed

Sponsors

Instituto de Salud Carlos III
CollaboratorOTHER_GOV
Complejo Hospitalario Universitario de Albacete
CollaboratorOTHER
Hospital de Cruces
CollaboratorOTHER
Hospital Clínico Universitario de Valladolid
CollaboratorOTHER
Hospitales Universitarios Virgen del Rocío
CollaboratorOTHER
Fundación de Investigación Biomédica - Hospital Universitario de La Princesa
CollaboratorOTHER
Hospital Universitario La Paz
CollaboratorOTHER
Hospital del Mar
CollaboratorOTHER
Hospital Arnau de Vilanova
CollaboratorOTHER
Complexo Hospitalario Universitario de A Coruña
CollaboratorOTHER
Red de Enfermedades Vasculares Cerebrales INVICTUS PLUS (Rd1600190024)
CollaboratorUNKNOWN
Fundació Institut de Recerca de l'Hospital de la Santa Creu i Sant Pau
Lead SponsorOTHER

Study design

Observational model
COHORT
Time perspective
PROSPECTIVE

Eligibility

Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No

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.

Design outcomes

Primary

MeasureTime frame
Collateral Circulation gradeTrough the acute phase of stroke, an average of 24 hours

Contacts

Primary ContactJoan Martí-Fàbregas, MD, PhD
jmarti@santpau.cat+34935565986
Backup ContactDaniel Guisado-Alonso, MD
dguisado@santpau.cat+34935565986

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026