COLISEUM: Collateral Circulation in Acute Ischemic Stroke With Large Vessel Occlusion
Study Details
Study Description
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.
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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 Design
Outcome Measures
Primary Outcome Measures
- Collateral Circulation grade [Trough the acute phase of stroke, an average of 24 hours]
Eligibility Criteria
Criteria
Inclusion Criteria:
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Patients with acute ischemic stroke.
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Large vessel occlusion of an intracranial internal artery: M1, M2 or TICA. (terminal intracranial carotid artery), as demonstrated by CTA.
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CTA performed within the first 24 hours after stroke onset. Patients with wake-up stroke are included.
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A previous modified Rankin Scale score of 0 to 3.
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The patient or a legal representative signs a written consent to participate.
Exclusion Criteria:
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More than 24 hours from last been known to be well.
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Occlusion of other arterial segments (vertebrobasilar circulation, A1, P1, M3, M4).
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Age below 18 years.
Contacts and Locations
Locations
No locations specified.Sponsors and Collaborators
- Fundació Institut de Recerca de l'Hospital de la Santa Creu i Sant Pau
- Instituto de Salud Carlos III
- Complejo Hospitalario Universitario de Albacete
- Hospital de Cruces
- Hospital Clínico Universitario de Valladolid
- Hospitales Universitarios Virgen del Rocío
- Fundación de Investigación Biomédica - Hospital Universitario de La Princesa
- Hospital Universitario La Paz
- Hospital del Mar
- Hospital Arnau de Vilanova
- Complexo Hospitalario Universitario de A Coruña
- Red de Enfermedades Vasculares Cerebrales INVICTUS PLUS (Rd1600190024)
Investigators
None specified.Study Documents (Full-Text)
None provided.More Information
Publications
None provided.- IIBSP-COL-2019-64