Collateral Circulation in Acute Ischemic Stroke With Large Vessel

Status Not yet recruiting

Clinical Trial 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.

Clinical Trial 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

Related Conditions & MeSH terms

Clinical Trial Details

NCT number	NCT04882657
Study type	Observational
Source	Fundació Institut de Recerca de l'Hospital de la Santa Creu i Sant Pau
Contact	Joan Martí-Fàbregas, MD, PhD
Phone	+34935565986
Email	jmarti@santpau.cat
Status	Not yet recruiting
Phase
Start date	June 1, 2021
Completion date	December 31, 2022

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Clinical trials are conducted in a series of steps, called phases - each phase is designed to answer a separate research question.

Phase 1: Researchers test a new drug or treatment in a small group of people for the first time to evaluate its safety, determine a safe dosage range, and identify side effects.
Phase 2: The drug or treatment is given to a larger group of people to see if it is effective and to further evaluate its safety.
Phase 3: The drug or treatment is given to large groups of people to confirm its effectiveness, monitor side effects, compare it to commonly used treatments, and collect information that will allow the drug or treatment to be used safely.
Phase 4: Studies are done after the drug or treatment has been marketed to gather information on the drug's effect in various populations and any side effects associated with long-term use.

Collateral Circulation in Acute Ischemic Stroke With Large Vessel Occlusion — COLISEUM

Clinical Trial Summary

Clinical Trial Description

Study Design

Related Conditions & MeSH terms