Screening of Endovascular Thrombectomy With MRI in Acute Ischemic Stroke

NCT ID: NCT06213870

Last Updated: 2024-01-19

Basic Information

• Recruitment Status: COMPLETED
• Total Enrollment: 309 participants
• Study Classification: OBSERVATIONAL
• Study Start Date: 2022-08-01
• Study Completion Date: 2023-11-01

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.

Conditions

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

Study Design

• Observational Model Type: COHORT
• Study Time Perspective: RETROSPECTIVE

Study Groups

MRI group

MRI Images were acquired on a 3T Siemens Prisma scanner (Siemens AG, Munich, Germany).Image sequences and typical parameter ranges were diffusion tensor imaging (repetition time [TR], 5200ms; echo time [TE], 80 ms; 4mm slice thickness; 40 slices) by using SE-EPI sequence; T1 imaging (TR, 240 ms; TE, 2.47 ms; 5 mm slice thickness; 17 slices) by using SE sequence;T2 imaging (TR, 4480 ms; TE, 99 ms; 4 mm slice thickness; 24 slices) by using FSE sequence; FLAIR imaging (TR, 8500 ms; TE, 95 ms; 5 mm slice thickness; 21 slices) by using IR sequence; time-of-flight magnetic resonance angiography images (TR, 20 ms; TE, 3 ms; 0.55 mm slice thickness; 40 slices) by using 3D-TOF sequence;

In the MRI group, patients with FVH-DWI mismatch were considered to have EVT indications and were treated with EVT, while patients without FVH-DWI mismatch were treated with medication.

Surgical criteria

Intervention Type: DIAGNOSTIC_TEST

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.

Perfusion group

The protocol of CT Perfusion was as follows: 100 mm coverage in the z-axis, tube voltage, 80 kV; tube current, 120 mA; section thickness, 5 mm. Twenty-four consecutive spiral acquisitions with 0.28 seconds of rotation time and 1.70 seconds of inter scan delay time were performed.

Patients in the perfusion group were treated with EVT when there exist perfusion mismatch(defined as regional cerebral blood flow (<30%) was < 70 ml with mismatch ratio ≥ 1.8 and mismatch volume ≥ 15 ml), and were treated with medication when there was no perfusion mismatch.

Surgical criteria

Intervention Type: DIAGNOSTIC_TEST

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.

Interventions

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.

Intervention Type: DIAGNOSTIC_TEST

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

• Minimum Eligible Age: 18 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Tianjin Huanhu Hospital

OTHER

Sponsor Role: lead

Responsible Party

Ming Wei

Chief Physician

Responsibility Role: PRINCIPAL_INVESTIGATOR

Principal Investigators

Ming Wei, PhD

Role: PRINCIPAL_INVESTIGATOR

Tianjin Huanhu Hospital

Locations

Tianjin Huanhu Hospital

Tianjin, Tianjin Municipality, China

Countries

China

Other Identifiers

TJHH-2023-WM51

Identifier Type: -

Identifier Source: org_study_id