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Completed

NCT Number: NCT06213870

Screening of Endovascular Thrombectomy With MRI in Acute Ischemic Stroke

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.

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Key information

Age range

18 year and older

Sex eligibility

All sexes

Study type

Observational

Primary location

Tianjin Huanhu Hospital

Tianjin, Tianjin Municipality, China

About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

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.

Primary outcomes

  1. 90-day functional independence rate

    Time frame: 90days

    Proportion of patients with mRS0-2 scores at 90 days

Secondary outcomes

  1. symptomatic intracranial hemorrhage

    Time frame: 90days

    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

Other outcomes

  1. 90-day mortality

    Time frame: 90days

    Death from any cause within 90 days

Sponsors and collaborators

Lead sponsor

Tianjin Huanhu Hospital

Other

Registry information

Important dates

Study start
2022
Primary completion
2023
Study completion
2023
First posted
Jan 19, 2024
Registry last updated
Jan 19, 2024

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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