Acute Ischemic Stroke Clinical Trial
— AsgctsisOfficial title:
Application of Standardized Green Channel Treatment System for Ischemic Stroke in Xi 'an
NCT number | NCT05424978 |
Other study ID # | SYLL-2021-024 |
Secondary ID | |
Status | Recruiting |
Phase | |
First received | |
Last updated | |
Start date | June 1, 2022 |
Est. completion date | July 31, 2028 |
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.
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 |
Country | Name | City | State |
---|---|---|---|
China | Xi 'an No.3 Hospital | Xi'an | Shaanxi |
Lead Sponsor | Collaborator |
---|---|
Xi'an No.3 Hospital |
China,
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. |
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