Screening of Endovascular Thrombectomy With MRI in Acute Ischemic Stroke

NCT06213870 | Completed DMC

• 1 other identifier: TJHH-2023-WM51
• Study Type: observational
• Target: 309
• Locations: 1 country
• Sites: 1

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.

Conditions

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

Keywords

FVH-DWI mismatch;Endovascular Thrombectomy

Outcome Measures

Primary Outcomes (1)

• 90-day functional independence rate

  Proportion of patients with mRS0-2 scores at 90 days

  90days

Secondary Outcomes (1)

• symptomatic intracranial hemorrhage

  90days

Other Outcomes (1)

• 90-day mortality

  90days

Study Arms (2)

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.

Diagnostic Test: Surgical criteria

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.

Diagnostic Test: Surgical criteria

Interventions

Surgical criteria 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.

MRI group; Perfusion group

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)
• Sampling Method: Non-Probability Sample

Study Population

Patients were recruited in Tianjin Huanhu hospital in China between August 1, 2022, and Augut 1, 2023.

You may qualify if:

• (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.

You may not qualify if:

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

Sponsors & Collaborators

• Tianjin Huanhu Hospital: lead

Study Sites (1)

Tianjin Huanhu Hospital

Tianjin, Tianjin Municipality, China

Location

Study Officials

• Ming Wei, PhD

  Tianjin Huanhu Hospital

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: RETROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Chief Physician

Study Record Dates

• First Submitted: January 9, 2024
• First Posted: January 19, 2024
• Study Start: August 1, 2022
• Primary Completion: August 1, 2023
• Study Completion: November 1, 2023
• Last Updated: January 19, 2024

Record last verified: 2024-01

Locations

CN (1)