To evaluate early cerebral perfusion changes of the ischemic brain after IVT and/or EVT in relation to progression of infarct core assessed by arterial Spin Labeling perfusion MRI.
ID
Source
Brief title
Condition
- Vascular haemorrhagic disorders
Synonym
Research involving
Sponsors and support
Intervention
Outcome measures
Primary outcome
The primary outcome of this study is the delta Cerebral Blood Flow (CBF) and
infarct volume between time points 0 and 60 minutes.
Secondary outcome
Secondary outcomes are the changes in CBF and concordant infarct volume
evolution over different time points early after treatment (+30, +90, +120,
+240 minutes).
Background summary
Intravenous tissue-type plasminogen activator (tPA) administration and
endovascular treatment (EVT) in patients with acute ischemic stroke has led to
recanalization rates up to 80% in recent clinical trials.
Although recanalization is essential for clinical recovery of stroke patients,
about one third of patients do not recover to functional independence even
despite fast and successful opening of the occluded vessel.
Recent findings suggest this discrepancy in treatment success and clinical
outcome can to some extent be attributed to incomplete microvascular
reperfusion (IMR).
Although IMR is suggested to be an important predictor of clinical outcome,
little is known about microvascular reperfusion in acute stroke population and
its relation to infarct evolution.
Study objective
To evaluate early cerebral perfusion changes of the ischemic brain after IVT
and/or EVT in relation to progression of infarct core assessed by arterial Spin
Labeling perfusion MRI.
Study design
Single center prospective observational cohort study
Study burden and risks
Patients will undergo repeated MRI directly after intravenous tPA and/or EVT at
multiple time points (+0, +30, +60, +90, +120, +240 minutes).
The current scan protocol does not require administration of any contrast media
or ionizing radiation.
The patients will not directly benefit from participation in the study.
Scientific benefit: Data on changes in cerebral perfusion and infarct evolution
seen on MRI directly after intravenous tPA and or EVT for ischemic stroke could
potentially differentiate successful from unsuccessful recovery.
Results from this study add to the pathophysiological knowledge of acute
ischemic stroke evolution, will provide novel imaging parameters useful as
early outcome measures in stroke trials and could potentially 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
-NIHSS >/=2
-Treated with intravenous tPA <4.5 h after symptom onset and/or treated with
EVT <6 hours after
symptom onset for a large vessel occlusion of the anterior circulation
(distal intracranial carotid artery or middle cerebral artery (M1 segment or
proximal M2 segment))
confirmed by neuroimaging (CTA or MRA) resulting in a successful
recanalization (defined as
mTICI 2B-3)
-Written informed consent obtained
Exclusion criteria
-Any previous stroke or known neurological disorder associated with structural
brain abnormalities
-Any contra-indication for MRI (e.g. ferromagnetic implant(s), claustrophobia,
pacemaker)
-Clinical condition unsuited for repetitive MRI imaging or prolonged stay at
the Radiology department.
-Pre-stroke modified Rankin Scale score > 2
-Participation in stroke trials interfering with the current study
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 | NL69823.078.19 |