Application of Standardized Green Channel Treatment System for Ischemic Stroke in Xi 'an (Asgctsis)

January 24, 2024 updated by: Xi'an No.3 Hospital
Objective: To observe the practical application of the standardized green channel treatment system for stroke in Xi 'an in the real world. Methods: Clinical data and information of patients with acute ischemic stroke who received standardized green channel treatment for stroke were collected, and a multicenter observational clinical study was carried out in the real world to evaluate the prognosis, mortality, incidence of asymptomatic and symptomatic cerebral hemorrhage, incidence of pneumonia, and recurrence rate of stroke after 90 days.

Study Overview

Status

Recruiting

Conditions

Intervention / Treatment

Detailed Description

The standardized green channel treatment system for acute ischemic stroke includes: Triage nurse triage timely, rapid assessment emergency doctor, suspected stroke the green channel, immediately start in the green channel of stroke accompanied by doctors and nurses stroke patients improve CT examination, intravenous thrombolysis or CT room, emergency room if considering large vascular lesions and the onset time in 6 hours, and rapidly to international for endovascular treatment, if the onset time of more than 6 hours, Rapid evaluation of ischemic penumbra and vascular occlusion by multi-mode imaging. If there are indications for endovascular treatment, go to the cath room for endovascular treatment as soon as possible.

Study Type

Observational

Enrollment (Estimated)

3600

Contacts and Locations

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

Study Contact

Study Locations

  • China
    • Shaanxi
      • Xi'an, Shaanxi, China, 710018

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 to 100 years (Adult, Older Adult)

Accepts Healthy Volunteers

No

Sampling Method

Non-Probability Sample

Study Population

Patients with acute ischemic stroke within 24 hours of onset; Receive standardized green channel treatment for stroke

Description

Inclusion Criteria:

  • 18 years old;
  • Consistent with the diagnosis of acute ischemic stroke;
  • 24 hours from onset to enrollment;
  • Informed consent

Exclusion Criteria:

  • Patients who refuse to receive intravenous thrombolysis or intravascular intervention (including intravascular mechanical thrombolysis and arterial thrombolysis);
  • Stroke patients caused by brain tumor, brain trauma and blood diseases;
  • Those with a history of stroke and sequelae affecting the outcome assessment, namely, mRS 2 points before the onset of this stroke;
  • Combined with claudication osteoarthritis rheumatoid arthritis gout arthritis and other limb dysfunction and affect the neurological function examination;
  • Patients with severe hepatic and renal insufficiency (Note: Hepatic insufficiency refers to ALT or AST values greater than 2 times the upper normal limit; Renal insufficiency refers to blood creatinine value greater than 2 times the normal upper limit);
  • Suffering from other serious life-threatening diseases with an expected survival time of less than 3 months;
  • Other diseases that limit neurological function evaluation or affect patient follow-up;
  • A woman planning to be pregnant or breastfeeding;
  • Currently participating in other clinical trials;
  • Refuse to participate in the registration of investigators

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

  • Observational Models: Cohort
  • Time Perspectives: Prospective

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Rate of function independent
Time Frame: 90 days after onset
Rate of modified Rankin Scale(mRS) score less than 3 at 90 days
90 days after onset

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Rate of mortality
Time Frame: 90 days after onset
90-day mortality rate
90 days after onset
Rate of stroke recurrence
Time Frame: 90 days after onset
90-day stroke recurrence rate
90 days after onset
Rate of cerebral hemorrhage and pneumonia
Time Frame: During hospitalization.
Incidence of cerebral hemorrhage and pneumonia after thrombolysis or intravascular therapy
During hospitalization.

Collaborators and Investigators

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

Sponsor

Xi'an No.3 Hospital

Investigators

  • Study Director: Ye Tian, Doctor, The dean

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)

June 1, 2022

Primary Completion (Estimated)

July 31, 2025

Study Completion (Estimated)

July 31, 2028

Study Registration Dates

First Submitted

June 1, 2022

First Submitted That Met QC Criteria

June 17, 2022

First Posted (Actual)

June 21, 2022

Study Record Updates

Last Update Posted (Estimated)

January 26, 2024

Last Update Submitted That Met QC Criteria

January 24, 2024

Last Verified

January 1, 2024

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

  • SYLL-2021-024

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

UNDECIDED

IPD Plan Description

Data is managed by the project team and can be shared according to individual needs

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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