Clinical trial NCT06213870: Screening of Endovascular Thrombectomy With MRI in Acute Ischemic Stroke
Official title: Screening of Endovascular Thrombectomy With MRI in Acute Ischemic Stroke
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Fluid-attenuated Inversion Recovery Sequence Vascular Hyperintensity-diffusion-weighted Imaging Mismatch(FVH-DWI Mismatch)
Image Evaluation
Endovascular Thrombectomy
Keywords: FVH-DWI mismatch;Endovascular Thrombectomy
Lead sponsor: Tianjin Huanhu Hospital
Sponsor class: OTHER
First posted: 2024-01-19
Enrollment: 309
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: COHORT
Time perspective: RETROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: Patients were recruited in Tianjin Huanhu hospital in China between August 1, 2022, and Augut 1, 2023.

Brief 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.

Detailed 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.

Eligibility criteria: Inclusion Criteria:

* (1) age ≥ 18 years old;
* (2) symptoms consistent with acute ischemic stroke and an onset time of 6-24h;
* (3) CT ASPECTS score≥6 points;NIHSS≥6points; modified Rankin scale (mRS) of 0-2 points prior to stroke;
* (4) internal carotid artery (ICA) and/or M1 segment of middle cerebral artery (MCA-M1) and M2 proximal segment occlusion with definite diagnosis.
* (5)agree to comply with the protocol follow-up requirements.

Exclusion Criteria:

* (1)Image unanalyzable.
* (2)3 months follow-up was not completed

Primary outcomes:
measure: 90-day functional independence rate
timeFrame: 90days
Secondary outcomes:
measure: symptomatic intracranial hemorrhage
timeFrame: 90days
Other outcomes:
measure: 90-day mortality
timeFrame: 90days
Locations:
city: Tianjin
country: China
facility: Tianjin Huanhu Hospital
state: Tianjin
Study officials:
affiliation: Tianjin Huanhu Hospital
name: Ming Wei, PhD
role: PRINCIPAL_INVESTIGATOR
References: