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

Acute Ischemic Stroke Clinical Trial

— Asgctsis  

Official title:

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

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT05424978
• Other study ID #: SYLL-2021-024
• Status: Recruiting
• Start date: June 1, 2022
• Est. completion date: July 31, 2028

Study information

• Verified date: January 2024
• Source: Xi'an No.3 Hospital
• Contact: Mingze Chang, Doctor
• Phone: 8615609250698
• Email: changmingze191[@]163.com
• Is FDA regulated: No
• Study type: Observational [Patient Registry]

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 3600
• Est. completion date: July 31, 2028
• Est. primary completion date: July 31, 2025
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years to 100 Years

Eligibility

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

Related Conditions & MeSH terms

• Acute Ischemic Stroke
• Cerebral Infarction
• Endovascular Treatment
• Ischemia
• Ischemic Stroke
• Stroke
• Thrombolysis

Intervention

Other:
• Standardized green channel treatment methods for stroke
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.

Locations

Country	Name	City	State
China	Xi 'an No.3 Hospital	Xi'an	Shaanxi

Sponsors (1)

Lead Sponsor	Collaborator
Xi'an No.3 Hospital

Country where clinical trial is conducted

China, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Rate of function independent	Rate of modified Rankin Scale(mRS) score less than 3 at 90 days	90 days after onset
Secondary	Rate of mortality	90-day mortality rate	90 days after onset
Secondary	Rate of stroke recurrence	90-day stroke recurrence rate	90 days after onset
Secondary	Rate of cerebral hemorrhage and pneumonia	Incidence of cerebral hemorrhage and pneumonia after thrombolysis or intravascular therapy	During hospitalization.