Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Acute ischemic stroke is the most common type of stroke in China, accounting for 69.6% -72.8% of new strokes. In recent years, the proportion of mild stroke (NIHSS ≤ 5 points) has gradually increased, exceeding 50%, and the recurrence rate of stroke within one year is 13.2%, with a mortality rate of 6.3%, and 4% -10% may experience early deterioration of neurological function within 72 hours. At present, the main treatment for mild ischemic stroke is antiplatelet aggregation or anticoagulation drugs, but there are still 10% -20% of patients with residual neurological disability. There is still controversy over whether acute reperfusion therapy (including intravenous thrombolysis and endovascular intervention therapy) can improve the prognosis of such patients. In addition, it has been confirmed that beyond the time window thrombolysis is effective for selected ischemic stroke patients, but it is urgent to clarify whether mild ischemic stroke patients can benefit from receiving beyond the time window thrombolysis. Due to the limited evidence and inconsistent conclusions on the efficacy and safety of reperfusion therapy in patients with mild stroke, it is urgent to have a deeper understanding of the current status of reperfusion therapy for mild ischemic stroke in China based on real clinical data, and systematically compare the efficacy and safety of reperfusion therapy (including intravenous thrombolysis and endovascular intervention therapy) with standard drug therapy for this type of patient. This project plans to conduct a nationwide multicenter prospective cohort study to evaluate the differences in excellent neurological function prognosis (mRS ≤ 1) and symptomatic intracranial hemorrhage rate among patients with mild ischemic stroke who receive reperfusion therapy (intravenous thrombolysis ± endovascular intervention therapy) compared to standard drug therapy at 90 days, in order to guide accurate clinical decision-making. The research results have significant implications for improving the prognosis of patients with mild ischemic stroke, and will also lay an important foundation for future large-scale randomized controlled studies to explore the optimal treatment strategies for mild stroke.
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Reperfusion therapy cohort | intravenous thrombolysis ± endovascular therapy, endovascular therapy alone | ||
| Standard of care cohort | Recommended by guidelines for secondary stroke prevention, e.g. dual/mono antiplatelet, antihypertensive or lipid-lowing therapy, et al |
Not provided
| Measure | Description | Time Frame |
|---|---|---|
| Proportion of modified Rankin scale score 0-1 | Modified Rankin Scale score ranges from 0 to 6, and lower score means better functional independence. | Day 90 |
| Measure | Description | Time Frame |
|---|---|---|
| Proportion of Modified Rankin Scale score 0-2 | Modified Rankin Scale score ranges from 0 to 6, and lower score means better functional independence. | Day 90 |
| Proportion of Modified Rankin Scale score 0-3 |
| Measure | Description | Time Frame |
|---|---|---|
| Proportion of symptomatic intracerebral hemorrhage (ECASS III) | Day 7 or discharge | |
| Proportion of moderate or severe systemic bleeding (The GUSTO criteria) | Day 7 or discharge | |
Inclusion Criteria:
Exclusion Criteria:
Not provided
Not provided
Not provided
Patients with minor ischemic stroke (NIHSS ≤ 5) within 24h from onset
| Name | Role | Phone | Extension | |
|---|---|---|---|---|
| Jinsheng Zeng, MD, PhD | Contact | +86-13322800657 | zengjs@pub.guangzhou.gd.cn | |
| Yicong Chen, MD, PhD | Contact | +86-15914325270 | chenyc37@mail.sysu.edu.cn |
| Name | Affiliation | Role |
|---|---|---|
| Jinsheng Zeng, MD, PhD | First Affiliated Hospital, Sun Yat-Sen University | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| The First Affiliated Hospital, Sun Yat-Sen University | Guangzhou | Guangdong | 510080 | China |
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Modified Rankin Scale score ranges from 0 to 6, and lower score means better functional independence.
| Day 90 |
| Ordinal Modified Rankin Scale score | Modified Rankin Scale score ranges from 0 to 6, and lower score means better functional independence. | Day 90 |
| Change from baseline in National Institutes of Health Stroke Scale | National Institutes of Health Stroke Scale ranges from 0 to 42, and higher score indicates more severe neurologic deficits. | Hour 24 |
| Change from baseline in National Institutes of Health Stroke Scale | National Institutes of Health Stroke Scale ranges from 0 to 42, and higher score indicates more severe neurologic deficits. | Hour 72 |
| National Institutes of Health Stroke Scale | National Institutes of Health Stroke Scale ranges from 0 to 42, and higher score indicates more severe neurologic deficits. | Day 7 or discharge (whichever comes first) |
| Barthel Index score | Barthel Index ranges from 0 to 100, and higher score means more functional independence. | Day 90 |
| Proportion of patients with door-to-needle time < 60 minutes | immediately after the intervention |
| Mortality |
| Day 90 |