Screening of Endovascular Thrombectomy With MRI in Acute Ischemic Stroke

Endovascular Thrombectomy Clinical Trial

Official title:

Screening of Endovascular Thrombectomy With MRI in Acute Ischemic Stroke

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT06213870
• Other study ID #: TJHH-2023-WM51
• Status: Completed
• 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
• 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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 309
• Est. completion date: November 1, 2023
• Est. primary completion date: August 1, 2023
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

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

Related Conditions & MeSH terms

• Endovascular Thrombectomy
• Image Evaluation
• Ischemic Stroke

Intervention

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.

Locations

Country	Name	City	State
China	Tianjin Huanhu Hospital	Tianjin	Tianjin

Sponsors (1)

Lead Sponsor	Collaborator
Tianjin Huanhu Hospital

Country where clinical trial is conducted

China, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Other	90-day mortality	Death from any cause within 90 days	90days
Primary	90-day functional independence rate	Proportion of patients with mRS0-2 scores at 90 days	90days
Secondary	symptomatic intracranial hemorrhage	according to the definition proposed by European Cooperative Acute Stroke Study III: intracranial hemorrhage that is associated with deterioration in NIHSS of 4 or more points and the main reason for neurological deterioration	90days