Collateral Circulation in Acute Ischemic Stroke With Large Vessel Occlusion (COLISEUM)

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

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.

Study Overview

• Status: Not yet recruiting
• Conditions: Stroke, Ischemic; Stroke, Acute; Collateral Circulation, Any Site

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.

• Study Type: Observational
• Enrollment (Anticipated): 700

Contacts and Locations

• Study Contact: Name: Joan Martí-Fàbregas, MD, PhD; Phone Number: +34935565986; Email: jmarti@santpau.cat
• Study Contact Backup: Name: Daniel Guisado-Alonso, MD; Phone Number: +34935565986; Email: dguisado@santpau.cat

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 14 years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

• Sampling Method: Probability Sample

Study Population

Patients with acute ischemic stroke and a large-vessel intracranial occlusion.

Description

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.

Study Plan

How is the study designed?

Design Details

• Observational Models: Cohort
• Time Perspectives: Prospective

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Time Frame
Collateral Circulation grade	Trough the acute phase of stroke, an average of 24 hours

Collaborators and Investigators

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

Study record dates

Study Major Dates

• Study Start (Anticipated): June 1, 2021
• Primary Completion (Anticipated): September 30, 2022
• Study Completion (Anticipated): December 31, 2022

Study Registration Dates

• First Submitted: December 5, 2019
• First Submitted That Met QC Criteria: May 11, 2021
• First Posted (Actual): May 12, 2021

Study Record Updates

• Last Update Posted (Actual): May 12, 2021
• Last Update Submitted That Met QC Criteria: May 11, 2021
• Last Verified: May 1, 2021

More Information

Terms related to this study

• Keywords: Ischemic Stroke; Large Vessel Occlusion; Collateral Circulation
• Additional Relevant MeSH Terms: Pathologic Processes; Cardiovascular Diseases; Vascular Diseases; Cerebrovascular Disorders; Brain Diseases; Central Nervous System Diseases; Nervous System Diseases; Stroke; Ischemic Stroke; Ischemia
• Other Study ID Numbers: IIBSP-COL-2019-64

Plan for Individual participant data (IPD)

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

Drug and device information, study documents

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