Carotid Duplex Ultrasound for Selecting Patients for Endovascular Thrombectomy in Acute Stroke Patients (ECHO-SELECT)

February 18, 2020 updated by: Ryo Itabashi

Emergent Carotid Ultrasound in Hyperacute Cerebral Vessel Occlusion for Selecting Patients to be Treated With Endovascular Clot Retrieval Treatment

The aim of this study is to address the usefulness of carotid duplex ultrasound as vascular imaging for selecting acute stroke patients for endovascular thrombectomy.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Study Type

Interventional

Enrollment (Actual)

40

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • Japan
    • Miyagi
      • Sendai, Miyagi, Japan, 9828523
        • Kohnan Hospital

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years and older (ADULT, OLDER_ADULT)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

Inclusion Criteria:

  • Endovascular treatment can be initiated within 6 hours of symptom onset.
  • ASPECTS of >=6 is diagnosed by two or more stroke physicians.
  • The end diastolic velocity in the common carotid arteries or internal carotid artery is evaluated by carotid duplex ultrasound
  • NIHSS score of >=6.
  • Age>=18 years.
  • Written informed consent is obtained.

Exclusion Criteria:

  • Pre-stroke modified Rankin Scale (mRS) score >=2.
  • Difficulties to evaluate ASPECTS on initial CT.
  • Difficulties to groin puncture.
  • History of severe allergic reaction to contrast medium.
  • End stage renal disease.

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: TREATMENT
  • Allocation: NA
  • Interventional Model: SINGLE_GROUP
  • Masking: NONE

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
EXPERIMENTAL: carotid duplex ultrasound
Single arm study. After detection of occluded vessels by vascular imaging using carotid duplex ultrasound, digital subtraction angiography is immediately performed before acute endovascular treatment.
Procedure: After detection of occluded vessels by vascular imaging using carotid duplex ultrasound, digital subtraction angiography is immediately performed before acute endovascular treatment.
When the ratio of the end diastolic velocity in the common carotid arteries is greater than 1.4 or the diastolic flow in the internal carotid artery is not detected by vascular imaging using carotid duplex ultrasound, digital subtraction angiography is immediately performed before acute endovascular treatment. If vessel occlusion is not detected by carotid duplex ultrasound, additional vascular imaging including MR angiography or CT angiography is considered.

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Time Frame
modified Rankin Scale
Time Frame: at 90 days after onset
at 90 days after onset

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Ryo Itabashi

Investigators

  • Principal Investigator: Ryo Itabashi, MD, Kohnan Hospital

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (ACTUAL)

October 1, 2016

Primary Completion (ACTUAL)

June 30, 2019

Study Completion (ACTUAL)

October 30, 2019

Study Registration Dates

First Submitted

December 8, 2016

First Submitted That Met QC Criteria

December 9, 2016

First Posted (ESTIMATE)

December 12, 2016

Study Record Updates

Last Update Posted (ACTUAL)

February 20, 2020

Last Update Submitted That Met QC Criteria

February 18, 2020

Last Verified

February 1, 2020

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

  • KohnanSN01

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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