Endovascular treatmenT for Acute Ischemic Stroke in China (DETECT-China)

February 8, 2023 updated by: Hui-Sheng Chen, General Hospital of Shenyang Military Region

Endovascular treatmenT for Acute Ischemic Stroke in China: a Retrospective, National, Multi-center, Registry Study

This is a retrospective real world registry study, aiming to explore the effectiveness and safety of endovascular treatment of acute ischemic stroke in a Chinese population.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Study Type

Observational

Enrollment (Actual)

1000

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

  • China
      • Shenyang, China, 110016
        • Department of Neurology, General Hospital of Northern Theater Command

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

N/A

Genders Eligible for Study

All

Sampling Method

Non-Probability Sample

Study Population

all patients must receive endovascular treatment regardless of the time from onset to treatment.

Description

Inclusion Criteria:

  • Age: ≥ 18;
  • Ischemic stroke confirmed by head CT or MRI;
  • Patients receiving endovascular treatment;
  • First ever stroke or mRS≤2 after previous disease;
  • Complete and clear pre- and post-operative DSA images are available

Exclusion Criteria:

  • Imaging data not qualified for evaluation;
  • Absence of important clinical data;
  • The first 50 patients receiving endovascular treatment in a single centerr.

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

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Proportion of patients with modified Rankin Score (mRS) 0 to 2
Time Frame: Day 90
the minimum and maximum values of mRS are 0 and 6, respectively; higher mRS mean a worse outcome
Day 90

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Proportion of symptomatic intracranial hemorrhage (sICH)
Time Frame: 48 hours
sICH was defined as 4 or more increase in NIHSS caused by hemorrhage
48 hours
Changes in National Institute of Health stroke scale (NIHSS)
Time Frame: Day 2, 7, 14
the minimum and maximum values of NIHSS are 0 and 42, respectively; higher NIHSS mean a worse outcome
Day 2, 7, 14
Proportion of patients with modified Rankin Score 0 to 2
Time Frame: Day180, 360
Proportion of patients with modified Rankin Score 0 to 2
Day180, 360
Distribution of modified Rankin Score
Time Frame: Day 90, 180, 360
Distribution of modified Rankin Score after treatment
Day 90, 180, 360
Proportion of intraparenchymal hemorrhage (PH1 and PH2)
Time Frame: 48 hours
Proportion of intraparenchymal hemorrhage (PH1 and PH2) after treatment
48 hours
Proportion of death
Time Frame: Day 7
death due to any cause
Day 7
Changes in cerebral edema
Time Frame: 48 hours, 7 days
edema is determined by middle shift.
48 hours, 7 days

Collaborators and Investigators

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

Sponsor

General Hospital of Shenyang Military Region

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)

March 22, 2021

Primary Completion (ACTUAL)

February 8, 2023

Study Completion (ACTUAL)

February 8, 2023

Study Registration Dates

First Submitted

February 10, 2021

First Submitted That Met QC Criteria

February 10, 2021

First Posted (ACTUAL)

February 12, 2021

Study Record Updates

Last Update Posted (ACTUAL)

February 10, 2023

Last Update Submitted That Met QC Criteria

February 8, 2023

Last Verified

February 1, 2023

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

  • y (2021)013

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

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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