Acute Ischemic StrokeAsgctsisNCT05424978
Application of Standardized Green Channel Treatment System for Ischemic Stroke in Xi 'an
An observational study of Acute Ischemic Stroke and Thrombolysis, run by Xi'an No.3 Hospital at 1 site in China.
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… Read more about this study
- Who is it for?
- Ages 18 to 100 years
- Conditions the study is for
- Acute Ischemic Stroke, Thrombolysis, Endovascular Treatment
- What is being tested?
- Standardized green channel treatment methods for stroke
- Type of treatment
- Injection or infusion
- How many people
- 3,600 participants
- Where
- 1 siteChina
- Study dates
- 1 Jun 2022to 31 Jul 2028
- How long will I take part?
- 90 Days
- Phase
- Observational
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 100 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Study population: Patients with acute ischemic stroke within 24 hours of onset; Receive standardized green channel treatment for stroke
Who may be able to join
- 18 years old;
- Consistent with the diagnosis of acute ischemic stroke;
- 24 hours from onset to enrollment;
- Informed consent
Who cannot join
- 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;
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- 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
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
China1 site, 1 recruiting
- Recruiting
Xi 'an No.3 Hospital
Xi'an, Shaanxi, 710018
Mingze Chang, Doctor, 8615609250698, changmingze191@163.com
Shilin Li, Doctor, 8615398076154, lihuashiling@126.com
About this study
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.
Read the 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.
- Conditions
- Acute Ischemic Stroke, Thrombolysis, Endovascular Treatment
- Being tested
- Standardized green channel treatment methods for stroke
- Medical subject headings
- Ischemic Stroke
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Standardized green channel treatment methods for strokeOther
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.
What is being measured
The primary outcome is the main question the study is designed to answer.
Rate of function independent
Rate of modified Rankin Scale(mRS) score less than 3 at 90 days
Measured: 90 days after onset
Secondary outcomes (3)
Rate of mortality
90-day mortality rate
Measured: 90 days after onset
Rate of stroke recurrence
90-day stroke recurrence rate
Measured: 90 days after onset
Rate of cerebral hemorrhage and pneumonia
Incidence of cerebral hemorrhage and pneumonia after thrombolysis or intravascular therapy
Measured: During hospitalization.
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted21 Jun 2022
- Study start1 Jun 2022
- Primary completion31 Jul 2025 (estimated)
- Study completion31 Jul 2028 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Acute Ischemic StrokeStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Cohort
- Time perspective
- Prospective
- Enrolment
- 3,600 participants (estimated)
- Target duration
- 90 Days
Sponsor and investigators
- Lead sponsor
- Xi'an No.3 Hospital
- Sponsor type
- Other government
- Responsible party
- Sponsor
- Investigators
- Ye Tian, Doctor, Study director, The dean
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05424978
- Sponsor's protocol ID
- SYLL-2021-024
- Acronym
- Asgctsis
- Status last verified
- Jan 2024
- First submitted
- 1 Jun 2022
- Last updated
- 26 Jan 2024
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Undecided: Data is managed by the project team and can be shared according to individual needs
Study at a glance
From the registry record, last updated by the sponsor on 26 Jan 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Application of Standardized Green Channel Treatment System for Ischemic Stroke in Xi 'an
- ClinicalTrials.gov ID
- NCT05424978
- Acronym / sponsor ID
- Asgctsis / SYLL-2021-024
- Conditions
- Acute Ischemic Stroke, Thrombolysis, Endovascular Treatment
- Study type
- Observational
- Recruitment status
- Recruiting
- Enrolment
- 3,600 participants (estimated)
- Lead sponsor
- Xi'an No.3 HospitalOther government
- Study start
- 1 Jun 2022 (actual)
- Primary completion
- 31 Jul 2025 (estimated)
- Study completion
- 31 Jul 2028 (estimated)
- First posted
- 21 Jun 2022 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
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 design
- Observational model
- Cohort
- Time perspective
- Prospective
- Target follow-up
- 90 Days
Who may qualify
- Ages
- 18 to 100 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- Patients with acute ischemic stroke within 24 hours of onset; Receive standardized green channel treatment for stroke
Key inclusion criteria (4 listed)
- 18 years old;
- Consistent with the diagnosis of acute ischemic stroke;
- 24 hours from onset to enrollment;
- Informed consent
Key exclusion criteria (10 listed)
- 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);
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Standardized green channel treatment methods for strokeThe 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. | Other | – |
Primary outcome
Rate of function independent
Time frame: 90 days after onset
Rate of modified Rankin Scale(mRS) score less than 3 at 90 days
3 secondary outcomes
Rate of mortality
Time frame: 90 days after onset
Rate of stroke recurrence
Time frame: 90 days after onset
Rate of cerebral hemorrhage and pneumonia
Time frame: During hospitalization.
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 26 Jan 2024.
- Individual participant dataSharing planned: Undecided. Data is managed by the project team and can be shared according to individual needs
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
Ye Tian, Doctor study director
The dean
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Acute Ischemic Stroke and Thrombolysis, run by Xi'an No.3 Hospital at 1 site in China.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 4 inclusion and 10 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: looking for participants now, as of the sponsor's last update on 26 Jan 2024. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in China. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Mingze Chang, Doctor (8615609250698, changmingze191@163.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Rate of function independent (time frame: 90 days after onset). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 26 Jan 2024.