Clinical Trial Details
— Status: Completed
Administrative data
NCT number |
NCT06213870 |
Other study ID # |
TJHH-2023-WM51 |
Secondary ID |
|
Status |
Completed |
Phase |
|
First received |
|
Last updated |
|
Start date |
August 1, 2022 |
Est. completion date |
November 1, 2023 |
Study information
Verified date |
January 2024 |
Source |
Tianjin Huanhu Hospital |
Contact |
n/a |
Is FDA regulated |
No |
Health authority |
|
Study type |
Observational
|
Clinical Trial Summary
The goal of this observational study is to learn about the role of MRI evaluation based on
FVH-DWI mismatch principle in preoperative evaluation of endovascular thrombolectomy.
The main questions it aims to answer are:
- The consistency between MRI and perfusion examination in determining EVT indications.
- The consistency of functional independence rate between patients screening with MRI and
perfusion.
Description:
MRI is the preferred imaging mode in many centers,for the diffusion-weighted imaging (DWI)
sequences are highly sensitive to acute cerebral ischemia.In addition, MRI does not require
intravenous contrast agent, which is simpler and more popular than perfusion.Fluid-attenuated
inversion recovery (FLAIR)sequence vascular hyperintensity(FVH) is defined as focal,
serpentine, or linear hyperintensity that usually occurs in the Sylvian fissure and is
associated with large-vessel occlusion or stenosis.The FVH-DWI mismatch(defined as the FVH
extended beyond the boundary of the DWI cortical lesions) had been confirmed has excellent
sensitivity and specificity in predicting PWI-DWI mismatch.It is not well established whether
MRI based on FVH-DWI mismatch and perfusion evaluation differ in determining EVT indications
and outcomes.
The main objectives of this study were to (1) determine the proportion of patients eligible
for EVT surgery selected by MRI based on FVH-DWI mismatch vs perfusion in a large multicenter
registry and (2) identify statistical differences in functional outcomes and safety outcomes
between the two evaluation methods.
Patients with ischemic stroke with anterior-circulation large-vessel occlusion in the late
(6-24 h) time window from real-world, single center retrospective cohort registry were
compared.In the MRI group, patients with FVH-DWI mismatch underwent EVT surgery or were
otherwise treated with medication.In the perfusion group, surgical indications referring the
DEFUSE 3 standards. The primary outcome was 90-day functional independence rate (mRS score
≤2) in all patients included(including EVT patient and medication patients).Safety outcomes
included symptomatic intracranial hemorrhage (sICH), and 90-day mortality.