Ischemic StrokeCIV-ABAONCT04611178
Cerebellar Infarct Volume in Basilar Artery Stroke
An observational study of Ischemic Stroke, run by University Hospital, Montpellier at 1 site in France.
Trial summary
Preprocedural predictors of outcome in patients with acute basilar artery occlusion (ABAO) who underwent endovascular treatment (EVT) remain controversial. Our aim was to analyze if pre-EVT diffusion-weighted images cerebellar infarct volume (CIV) was a predictor of 90-day outcomes. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Ischemic Stroke
- What is being tested?
- Mechanical thrombectomy
- Type of treatment
- Medical device
- How many people
- 110 participants
- Where
- 1 siteFrance
- Study dates
- 30 Jan 2011to 1 Jan 2019
- Phase
- Observational
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Study population: All patients >18 years, referred to our hospital, from January 2011 to October 2018, presenting acute basilar artery occlusion (ABAO) confirmed by magnetic resonance imaging treated by endovascular thrombectomy, with or without intravenous thrombolysis.
Who may be able to join
- 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; and
- ABAO confirmed by intra-arterial arteriography and treated using mechanical thrombectomy.
Who cannot join
- 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
Trial locations and contacts
1 site in 1 country.
About this study
Official title: DWI Cerebellar Infarct Volume as Predictor of Outcomes After Endovascular Treatment of Acute Basilar Artery Occlusion
Preprocedural predictors of outcome in patients with acute basilar artery occlusion (ABAO) who underwent endovascular treatment (EVT) remain controversial. Our aim was to analyze if pre-EVT diffusion-weighted images cerebellar infarct volume (CIV) was a predictor of 90-day outcomes.
Read the 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 guidelines from learned societies, and 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 conflicting results. The rational for the brainstem scoring system was based on the anatomic architecture and the regional eloquence of brainstem, which may negatively influence functional outcome.
Nevertheless, one of the most significant and immediate dreaded complication, in patients with ABAO and cerebellar infarcts, is the development of a space-occupying edema. Due to the small volume of posterior fossa, cerebellar infarct with mass effect (CIMASS) contribute to a risk of catastrophic herniation with direct brainstem compression, hydrocephalus due to blockage of the fourth ventricle, or both. Up to 25% of patients with CIMASS deteriorate clinically resulting in morbidity and in mortality in 85% of patients without intervention. This potential risk of CIMASS, lead clinicians to strengthen clinical and radiological monitoring and modify therapeutic management with the recourse of live-saving suboccipital decompressive craniectomy (SDC), as recommended by learned societies.
Until now, little is known about predicting factors of outcomes in patients with ABAO treated by EVT and associated cerebellar infarct. In fact, there are no focusing research to assess if baseline cerebellar infarct volume (CIV) may correlate with 90-day clinical outcome and mortality, nor if such lesions would affect a reperfusion decision.
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 CIV was calculated in mL, on an apparent diffusion-coefficient map reconstruction (Olea sphere software).
CIV 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 CIV.
Our aim was to evaluate the frequency, the clinical, and radiological characteristics of cerebellar infarct, in a large cohort of ABAO selected by MRI prior to EVT, and to investigate the baseline CIV as a predictor of 90-day functional outcome and mortality.
- Conditions
- Ischemic Stroke
- Being tested
- Mechanical thrombectomy
- Keywords
- MRI, Posterior fossa, Thrombectomy, Stroke
- Medical subject headings
- Ischemic Stroke, Stroke
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Mechanical thrombectomyDevice
Stent retriever for treatment of cerebral arterial occlusions
| Study group | Role | What they receive |
|---|---|---|
| CIV-ABAO | CIV-ABAO Receives: Device: Mechanical thrombectomy |
What is being measured
The primary outcome is the main question the study is designed to answer.
Rate of Functional outcome at 90-day
90-day functional outcome A favorable outcome was defined as a 90-day mRS≤2.
Measured: 90 day
Secondary outcomes (1)
Mortality rate
Mortality and the cause of death at 90 days
Measured: 90 day
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted2 Nov 2020
- Study start30 Jan 2011
- Primary completion1 Oct 2018
- Study completion1 Jan 2019
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Ischemic StrokeStudies of the same condition, open and under way.
- More trials run by University Hospital, MontpellierThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Cohort
- Time perspective
- Retrospective
- Enrolment
- 110 participants (actual)
Sponsor and investigators
- Lead sponsor
- University Hospital, Montpellier
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Isabelle Mourand, MD, Principal investigator, University Hospital, Montpellier
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04611178
- Sponsor's protocol ID
- RECHMPL20_0596
- Acronym
- CIV-ABAO
- Status last verified
- Oct 2020
- First submitted
- 26 Oct 2020
- Last updated
- 10 Nov 2020
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Undecided: NC
Study at a glance
From the registry record, last updated by the sponsor on 10 Nov 2020. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- DWI Cerebellar Infarct Volume as Predictor of Outcomes After Endovascular Treatment of Acute Basilar Artery Occlusion
- ClinicalTrials.gov ID
- NCT04611178
- Acronym / sponsor ID
- CIV-ABAO / RECHMPL20_0596
- Conditions
- Ischemic Stroke
- Keywords
- MRI, Posterior fossa, Thrombectomy, Stroke
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 110 participants (actual)
- Lead sponsor
- University Hospital, MontpellierUniversity, hospital or other
- Study start
- 30 Jan 2011 (actual)
- Primary completion
- 1 Oct 2018 (actual)
- Study completion
- 1 Jan 2019 (actual)
- First posted
- 2 Nov 2020 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
Preprocedural predictors of outcome in patients with acute basilar artery occlusion (ABAO) who underwent endovascular treatment (EVT) remain controversial. Our aim was to analyze if pre-EVT diffusion-weighted images cerebellar infarct volume (CIV) was a predictor of 90-day 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 guidelines from learned societies, and 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 conflicting results. The rational for the brainstem scoring system was based on the anatomic architecture and the regional eloquence of brainstem, which may negatively influence functional outcome.
Nevertheless, one of the most significant and immediate dreaded complication, in patients with ABAO and cerebellar infarcts, is the development of a space-occupying edema. Due to the small volume of posterior fossa, cerebellar infarct with mass effect (CIMASS) contribute to a risk of catastrophic herniation with direct brainstem compression, hydrocephalus due to blockage of the fourth ventricle, or both. Up to 25% of patients with CIMASS deteriorate clinically resulting in morbidity and in mortality in 85% of patients without intervention. This potential risk of CIMASS, lead clinicians to strengthen clinical and radiological monitoring and modify therapeutic management with the recourse of live-saving suboccipital decompressive craniectomy (SDC), as recommended by learned societies.
Until now, little is known about predicting factors of outcomes in patients with ABAO treated by EVT and associated cerebellar infarct. In fact, there are no focusing research to assess if baseline cerebellar infarct volume (CIV) may correlate with 90-day clinical outcome and mortality, nor if such lesions would affect a reperfusion decision.
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 CIV was calculated in mL, on an apparent diffusion-coefficient map reconstruction (Olea sphere software).
CIV 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 CIV.
Our aim was to evaluate the frequency, the clinical, and radiological characteristics of cerebellar infarct, in a large cohort of ABAO selected by MRI prior to EVT, and to investigate the baseline CIV as a predictor of 90-day functional outcome and mortality.
Study design
- Observational model
- Cohort
- Time perspective
- Retrospective
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| CIV-ABAO | – | Device: Mechanical thrombectomyCIV-ABAO |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- All patients >18 years, referred to our hospital, from January 2011 to October 2018, presenting acute basilar artery occlusion (ABAO) confirmed by magnetic resonance imaging treated by endovascular thrombectomy, with or without intravenous thrombolysis.
Key inclusion criteria (4 listed)
- 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; and
- ABAO confirmed by intra-arterial arteriography and treated using mechanical thrombectomy.
Key exclusion criteria (4 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Mechanical thrombectomyStent retriever for treatment of cerebral arterial occlusions | Device | CIV-ABAO |
Primary outcome
Rate of Functional outcome at 90-day
Time frame: 90 day
90-day functional outcome A favorable outcome was defined as a 90-day mRS≤2.
1 secondary outcome
Mortality rate
Time frame: 90 day
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 10 Nov 2020.
- Individual participant dataSharing planned: Undecided. NC
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Isabelle Mourand, MD principal investigator
University Hospital, Montpellier
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Ischemic Stroke, run by University Hospital, Montpellier at 1 site in France.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 4 inclusion and 4 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 10 Nov 2020. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in France. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Rate of Functional outcome at 90-day (time frame: 90 day). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 10 Nov 2020.