The objective of this study is to assess the prognostic value of early perfusion changes and infarct evolution detected with magnetic resonance imaging (MRI) acquired directly after EVT.
ID
Source
Brief title
Condition
- Central nervous system vascular disorders
- Embolism and thrombosis
Synonym
Research involving
Sponsors and support
Intervention
Outcome measures
Primary outcome
The primary outcome of this study is the National Institutes of Health Stroke
Scale (NIHSS) 24 hours after successful recanalization.
Secondary outcome
Secondary radiological outcomes at 24 hours after successful recanalization:
- infarct volume on DWI/FLAIR
- intracerebral haemorrhage according to the Heidelberg Bleeding
Classification10 on SWI
- recanalization status on MRA
Secondary clinical outcomes:
- Modified Rankin Scale (mRS) score at 90 days (± 14 days)
- symptomatic intracranial haemorrhage (defined as haemorrhage detected on
brain imaging with >=4 points increase in NIHSS)
Background summary
Endovascular thrombectomy (EVT) is a highly effective treatment for acute
ischemic stroke, leading to recanalization rates of up to 80%. However, still
approximately one-third of patients do not recover to functional independence,
despite fast and complete reopening of the occluded artery by EVT. Clinical
evidence suggests that tissue reperfusion (i.e., complete restoration of the
downstream blood flow) is a better predictor of outcome than recanalization
(i.e., opening of the occluded artery). However, post-procedural surrogate
markers useful for discriminating successful from unsuccessful reperfusion are
lacking. Such markers are highly needed for selecting patients who may benefit
from additional (pharmacological) treatment.
Study objective
The objective of this study is to assess the prognostic value of early
perfusion changes and infarct evolution detected with magnetic resonance
imaging (MRI) acquired directly after EVT.
Study design
This is a single center prospective, observational cohort study conducted
within the Erasmus MC University Medical Center. It is a within-subject
ischemic stroke evaluation carried out with MRI. The expected study duration is
18 months.
Study burden and risks
Participants will undergo an MRI scan with administration of contrast material
directly after successful EVT and a second MRI scan without administration of
contrast material 24 hours after treatment. The current scan protocol does not
require exposing patients to any ionizing radiation. Additionally, functional
status (mRS score) will be assessed by telephone interview at 90 days after
treatment. Participants will not directly benefit from participation in this
study. Data on changes in cerebral perfusion and infarct evolution seen on MRI
directly after treatment could potentially differentiate successful from
unsuccessful recovery. Results from this study may thereby provide novel
imaging biomarkers useful as early outcome measures and contribute to the
selection of patients eligible for additional (pharmacological) treatment.
Dr. Molewaterplein 40
Rotterdam 3015 GD
NL
Dr. Molewaterplein 40
Rotterdam 3015 GD
NL
Listed location countries
Age
Inclusion criteria
- A clinical diagnosis of acute ischemic stroke
- Age 18 years or older
- Treated with EVT for a large vessel occlusion of the anterior circulation
(intracranial carotid artery or middle cerebral artery (M1 segment or M2
segment) confirmed by neuroimaging (CTA or MRA) resulting in a successful
recanalization (defined as eTICI >= 2B)
- Written informed consent obtained
Exclusion criteria
- Pre-stroke disability which interferes with assessment of functional outcome
at 90 days, i.e. mRS >2
- Contraindication(s) for MRI (e.g. claustrophobia, pacemaker, metallic
implant, known contrast allergy)
- Clinical condition unsuited for MRI imaging or prolonged stay at the
Radiology department (e.g. agitation and restlessness, neurologic deterioration)
- Use of general anesthesia during EVT
Design
Recruitment
Followed up by the following (possibly more current) registration
No registrations found.
Other (possibly less up-to-date) registrations in this register
No registrations found.
In other registers
| Register | ID |
|---|---|
| CCMO | NL79093.078.21 |