NCT06213870

Screening of Endovascular Thrombectomy With MRI in Acute Ischemic Stroke

• Status: Completed
• Phase: —
• Study type: Observational
• Enrollment: 309 (actual)
• Sponsor: Tianjin Huanhu Hospital · Academic / Other
• Sex: All
• Age: 18 Years
• Healthy volunteers: Not accepted

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.

Conditions

• Fluid-attenuated Inversion Recovery Sequence Vascular Hyperintensity-diffusion-weighted Imaging Mismatch(FVH-DWI Mismatch)
• Image Evaluation
• Endovascular Thrombectomy

Interventions

Type	Name	Description
DIAGNOSTIC_TEST	Surgical criteria	In the MRI group, patients with FVH-DWI mismatch underwent EVT surgery or were otherwise treated with medication. In the perfusion group, patients who meet the criteria of DEFUSE3 will receive EVT surgery, otherwise receive medication.

Timeline

• Start date: 2022-08-01
• Primary completion: 2023-08-01
• Completion: 2023-11-01
• First posted: 2024-01-19
• Last updated: 2024-01-19

Locations

1 site across 1 country: China