Total Posterior-circulation Infarct Volume in Basilar Artery Stroke

NCT ID: NCT04650022

Last Updated: 2020-12-08

Basic Information

• Recruitment Status: COMPLETED
• Total Enrollment: 110 participants
• Study Classification: OBSERVATIONAL
• Study Start Date: 2011-01-30
• Study Completion Date: 2019-01-01

Brief Summary

Preprocedural predictors of outcome in patients with acute basilar artery occlusion (ABAO) who underwent endovascular treatment (EVT) remain controversial. The Investigators aimed to analyse, in patients with ABAO treated by EVT, if pre-EVT DWI total posterior-circulation infarct volume (TPIV) was a predictor of 90-days outcomes

Detailed Description

Acute basilar artery occlusion (ABAO) is a rare and devastating type of stroke. Endovascular treatment (EVT) is routinely performed in real-world practice, encouraged by the recent result of the basilar artery international cooperation study (BASICS), a randomized controlled study.

ABAO may result in infarcts in the brainstem, cerebellar lobes, thalamus and subthalamic area, or occipitotemporal lobes. Previously, studies using the DWI Posterior-circulation Alberta Stroke Program Early CT (Pc-ASPECT) Score or brainstem score, for predicting outcome in patients with ABAO, showed that the initial infarct extend can affect outcome. Some of these studies included patients tretaed by EVT. But, results showed conflicting findings.

To date, evidence regarding the association between pre-ETVT DWI lesion volume and outcomes is relatively weak and has not yet be determined. Predictors of the outcomes of EVT for anterior circulation include infarcts volume. More recently, authors reported a predictive model of good outcome combining initial DWI infarct volume of less than 10 ml, onset-to-puncture time less than 8 hours and embolic origin in 71 Korean patients undergoing EVT for vertebrobasilar occlusion. Nevertheless, up now, there is not sufficient evidence to reach a consensus.

Using data of our prospective registry, the investigators analyzed consecutive MRI selected, endovascularly treated ABAO patients within the first 24h after symptom-onset. Using the initial Magnetic Resonance Imaging (MRI), baseline total posterior-Circulation infarct volume (TPCIV) was calculated in mL, on an apparent diffusion-coefficient map reconstruction (Olea sphere software).

TPCIV was analyzed in univariate and multivariable models as a predictor of 90-day functional independence (modified Rankin Scale [mRS] 0-2) and mortality. According to received operating characteristic (ROC) analysis, the optimal cut-off was determined by maximizing the Youden index, to evaluate the prognostic value of TPCIV.

The Investigators aimed to investigate the relationship between baseline DWI total TPCIV and the 90-days functional outcome and mortality, in a large cohort of ABAO selected by MRI prior to EVT.

Conditions

Ischemic Stroke

Keywords

MRI; Posterior fossa; Thrombectomy; Stroke

Study Design

• Observational Model Type: COHORT
• Study Time Perspective: RETROSPECTIVE

Study Groups

TPCIV-ABAO

TPCIV-ABAO

Mechanical thrombectomy

Intervention Type: DEVICE

Stent retriever for treatment of cerebral arterial occlusions

Interventions

Mechanical thrombectomy

Stent retriever for treatment of cerebral arterial occlusions

Intervention Type: DEVICE

Eligibility Criteria

Inclusion Criteria

• patient with a clinical diagnosis of acute stroke in the posterior-circulation within 24 hours from symptom onset;
• patient with a pertinent clinical deficit following physician evaluation (no NIHSS limit);
• acute basilar ischemia assessed on MRI matching clinical symptoms and including DWI;
• ABAO confirmed by intra-arterial arteriography and treated using mechanical thrombectomy.

Exclusion Criteria

Patients were excluded if they were ineligible for an MRI or ineligible for MT for the following reasons:

• prestroke modified Rankin Scale (mRS) score of >2;
• life expectancy <3 months;
• brainstem ischemia on DWI involving more than 80% of the area in axial view

• Minimum Eligible Age: 18 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

University Hospital, Montpellier

OTHER

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Principal Investigators

Isabelle Mourand, MD

Role: PRINCIPAL_INVESTIGATOR

University Hospital, Montpellier

Locations

Uhmontpellier

Montpellier, , France

Countries

France

Other Identifiers

RECHMPL20_0636

Identifier Type: -

Identifier Source: org_study_id