Collateral Circulation in Acute Ischemic Stroke With Large Vessel Occlusion
NCT ID: NCT04882657
Last Updated: 2021-05-12
Study Results
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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UNKNOWN
700 participants
OBSERVATIONAL
2021-06-01
2022-12-31
Brief Summary
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Detailed Description
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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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Study Design
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COHORT
PROSPECTIVE
Eligibility Criteria
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Inclusion Criteria
* 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
* Occlusion of other arterial segments (vertebrobasilar circulation, A1, P1, M3, M4).
* Age below 18 years.
18 Years
ALL
No
Sponsors
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Instituto de Salud Carlos III
OTHER_GOV
Complejo Hospitalario Universitario de Albacete
OTHER
Hospital de Cruces
OTHER
Hospital Clínico Universitario de Valladolid
OTHER
Hospitales Universitarios Virgen del Rocío
OTHER
Fundación de Investigación Biomédica - Hospital Universitario de La Princesa
OTHER
Hospital Universitario La Paz
OTHER
Hospital del Mar
OTHER
Hospital Arnau de Vilanova
OTHER
Complexo Hospitalario Universitario de A Coruña
OTHER
Red de Enfermedades Vasculares Cerebrales INVICTUS PLUS (Rd1600190024)
UNKNOWN
Fundació Institut de Recerca de l'Hospital de la Santa Creu i Sant Pau
OTHER
Responsible Party
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Central Contacts
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Other Identifiers
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IIBSP-COL-2019-64
Identifier Type: -
Identifier Source: org_study_id
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