Total Posterior-circulation Infarct Volume in Basilar Artery Stroke (TPCIV-ABAO)
Predicting Value of DWI Total Posterior-circulation Infarct Volume for Endovascular Treatment Outcomes of Acute Basilar Artery Occlusion
Study Overview
Status
Conditions
Intervention / Treatment
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.
Study Type
Enrollment (Actual)
Contacts and Locations
Study Locations
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Montpellier, France, 34295
- Uhmontpellier
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Participation Criteria
Eligibility Criteria
Ages Eligible for Study
Accepts Healthy Volunteers
Genders Eligible for Study
Sampling Method
Study Population
Description
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
Study Plan
How is the study designed?
Design Details
Cohorts and Interventions
Group / Cohort |
Intervention / Treatment |
|---|---|
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TPCIV-ABAO
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Stent retriever for treatment of cerebral arterial occlusions
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What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
|---|---|---|
|
measuring the degree of disability or dependence in the daily activities of people who have suffered a stroke or other causes of neurological disability
Time Frame: 90 day
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90-day functional outcome A favorable outcome was defined as a 90-day mRS≤2
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90 day
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Secondary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
|---|---|---|
|
Mortality rate
Time Frame: 90 day
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Mortality and the cause of death at 90 days
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90 day
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Collaborators and Investigators
Sponsor
Study record dates
Study Major Dates
Study Start (ACTUAL)
Primary Completion (ACTUAL)
Study Completion (ACTUAL)
Study Registration Dates
First Submitted
First Submitted That Met QC Criteria
First Posted (ACTUAL)
Study Record Updates
Last Update Posted (ACTUAL)
Last Update Submitted That Met QC Criteria
Last Verified
More Information
Terms related to this study
Keywords
Additional Relevant MeSH Terms
Other Study ID Numbers
- RECHMPL20_0636
Plan for Individual participant data (IPD)
Plan to Share Individual Participant Data (IPD)?
IPD Plan Description
Drug and device information, study documents
Studies a U.S. FDA-regulated drug product
Studies a U.S. FDA-regulated device product
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