NCT05424978

Brief Summary

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.

Trial Health

77
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
3,600

participants targeted

Target at P75+ for all trials

Timeline
27mo left

Started Jun 2022

Longer than P75 for all trials

Geographic Reach
1 country

1 active site

Status
recruiting

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

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Study Timeline

Key milestones and dates

Study Progress64%
Jun 2022Jul 2028

First Submitted

Initial submission to the registry

June 1, 2022

Completed
Same day until next milestone

Study Start

First participant enrolled

June 1, 2022

Completed
20 days until next milestone

First Posted

Study publicly available on registry

June 21, 2022

Completed
3.1 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

July 31, 2025

Completed
3 years until next milestone

Study Completion

Last participant's last visit for all outcomes

July 31, 2028

Expected
Last Updated

January 26, 2024

Status Verified

January 1, 2024

Enrollment Period

3.2 years

First QC Date

June 1, 2022

Last Update Submit

January 24, 2024

Conditions

Outcome Measures

Primary Outcomes (1)

  • Rate of function independent

    Rate of modified Rankin Scale(mRS) score less than 3 at 90 days

    90 days after onset

Secondary Outcomes (3)

  • Rate of mortality

    90 days after onset

  • Rate of stroke recurrence

    90 days after onset

  • Rate of cerebral hemorrhage and pneumonia

    During hospitalization.

Interventions

The measures include six measures: timely triage by triage desk nurses; Rapid evaluation by emergency room physician; If stroke is suspected, the green channel for nosocomial stroke should be activated immediately. Stroke greenway doctors and stroke nurses accompanied patients to complete CT examination; Intravenous thrombolysis in emergency rooms or CT rooms; Suspected macrovascular disease, if the onset time is less than 6 hours, quickly go to the catheter room for intravascular treatment; If the onset time was more than 6 hours, multi-mode imaging was used to quickly evaluate the ischemic penumbra and vascular occlusion, and then the patients were sent to the catheter room for intravascular treatment as soon as possible.

Eligibility Criteria

Age18 Years - 100 Years
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)
Sampling MethodNon-Probability Sample
Study Population

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

You may qualify if:

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

You may not qualify if:

  • 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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Xi 'an No.3 Hospital

Xi'an, Shaanxi, 710018, China

RECRUITING

MeSH Terms

Conditions

Ischemic Stroke

Condition Hierarchy (Ancestors)

StrokeCerebrovascular DisordersBrain DiseasesCentral Nervous System DiseasesNervous System DiseasesVascular DiseasesCardiovascular Diseases

Study Officials

  • Ye Tian, Doctor

    The dean

    STUDY DIRECTOR

Central Study Contacts

Mingze Chang, Doctor

CONTACT

Study Design

Study Type
observational
Observational Model
COHORT
Time Perspective
PROSPECTIVE
Target Duration
90 Days
Sponsor Type
OTHER GOV
Responsible Party
SPONSOR

Study Record Dates

First Submitted

June 1, 2022

First Posted

June 21, 2022

Study Start

June 1, 2022

Primary Completion

July 31, 2025

Study Completion (Estimated)

July 31, 2028

Last Updated

January 26, 2024

Record last verified: 2024-01

Locations