Clinical Trial Details
— Status: Recruiting
Administrative data
NCT number |
NCT05735301 |
Other study ID # |
wm-v1003 |
Secondary ID |
|
Status |
Recruiting |
Phase |
N/A
|
First received |
|
Last updated |
|
Start date |
January 1, 2019 |
Est. completion date |
May 2024 |
Study information
Verified date |
March 2023 |
Source |
Tianjin Huanhu Hospital |
Contact |
Ming Wei, doctorate |
Phone |
13502182903 |
Email |
drweiming[@]163.com |
Is FDA regulated |
No |
Health authority |
|
Study type |
Interventional
|
Clinical Trial Summary
The acute management of stroke patients requires a fast and efficient screening imaging
modality. The primary modalities used to select patients for endovascular thrombectomy (EVT)
are magnetic resonance imaging (MRI) and CT/MR perfusion. The investigators prospectively
assessed MRI and CTP concordance/discordance and correlated the imaging on both with EVT
treatment decisions and clinical outcomes to verify the validity of MRI (FVH-DWI mismatch)
for the preoperative assessment of EVT in patients with an extended time window (6h to 24h).
Description:
The efficacy and safety of endovascular thrombectomy(EVT) in patients with acute ischemic
stroke(AIS) due to anterior circulation large vessel occlusion(LVO) is well established in
multiple randomized controlled trials (RCTs) in late (treatment) time windows (6-16hours),and
compared with medical therapy, EVT can significantly improve the prognosis. DEFUSE
3(EndovascularTherapy FollowingImagingEvaluationforIschemicStroke3)andDAWN
(DWIorCTPAssessmentWithClinicalMismatchintheTriageof
Wake-UpandLatePresentingStrokesUndergoing NeurointerventionWithTrevo)
reliedonCT-perfusion(CTP) or magneticresonancediffusion(DWI)and/orperfusion(PWI), and
utilized automated imaging analysis with Rapid Processing of Perfusion and Diffusion (RAPID;
iSchemaView, Menlo Park, CA) software to determine eligibility[2,3,4].Some use cerebral
infarction volume, presence or absence of cerebral hemorrhage and bleeding tendency, arterial
occlusion location, perfusion parameters (CBV<70 mL; The gold standard for mismatch ratio
≥1.8; mismatch volume >15 ml) toassess patients who were compatible with acute anterior
circulation LVO ischemic stroke undergoing arterial thrombectomy. The advantages of using
perfusion imaging assessment are the ability to identify DWI-negative cerebral ischaemia,
objectively evaluate ischemic semi-dark bands, and identify some cases of overperfusion.
However, for most centers, CT OR MRperfusion in the emergency department is limited, or the
appropriate analysis software is not available, and even imaging equipment does not support
perfusion.
As a result, most of the centers use multiparametric MR to screen EVT-eligible LVO patients.
In the study of DAWN,researchers use MR and some complicated criterias such as clinical
symptom-imaging mismatch, the relationship between age and NIHSS score to select patients who
meet 6-24hours with acute anterior circulation LVO, It wasa certain complex way to used in
clinical work, and difficult to promoting the application clinically.
All the acute ischemic stroke protocols are trying to find a way to balance theoptimal
screening assessment of EVT patients (with)and minimal imaging time to facilitate rapid and
effective treatment. Fast multiparametric MR sequences typically include DWI, FLAIR, MRA, and
gradient echo(GRE) sequences, further reducing the time and versatility of multiparametricMRI
scans, requiring more informations to be extracted from fewer sequences.
Early researches described that a rounded or serpentine brightening of the parenchyma or
cortical surface bordering the subarachnoid space in FLIAR sequence on MRI scan is called
fluid attenuation inversion recovery vascular hyperintensity(FVH). In a prospective study,
slow blood flow on the FLAIR sequence was associated with cerebral collateral circulation and
prognosis [12].At the same time, it has been suggested that FVH in the FLAIR sequence of the
MRI scan sequence can indirectly indicate LVO or vascular stenosis, and insufficient
collateral circulation leads to FVH and early ischemia [1]. According to our completed
retrospective study, FVH-DWI mismatch assessment and perfusion assessment showed good
interrater reliability( κ= 0.71,[95% CI, 0.62-0.81]). There is no statistical difference in
the rate of good clinical prognosis of patients undergoing EVT based on the two evaluation
methods(X2=0.204,P=0.652).
It has been found that FVHsign is an indicator of LVO or vascular stenosis, inadequate
collateral circulation leading to slow blood flow and early ischaemia. The presence of the
FVH sign is not only fairly consistent with areas of low perfusion, but its sensitivity and
specificity is similar to that of time-flight magnetic resonance angiography(MRA) for the
diagnosis of large vessel occlusion.DWI volume and FVH-DWI mismatch in acute stroke patients
might be useful for predicting functional outcome after stroke[10]. It was thus hypothesized
that FVH sign could be an important and convenient imaging manifestation reflecting the
under-perfusion of brain tissue in patients with cerebral infarction with LVO.
. In this study, a randomised controlled approach was adopted to assess the risk and
prognosis of endovascular treatment by using the "FVH-DWI mismatch" to determine the presence
of an ischemic penumbra and collateral circulation in patients, with the aim of establishing
a simple evaluation method based on the indirect evaluation of collateral circulation on MR
to screen patients who underwent thrombolysis at 6 to 24 hours overtime. It may be similar to
the perfuse evaluation system, but is more easily replicable.