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Telemedicine-supported stroke care can provide standardized guidance to hospitals and regions with limited medical resources, thereby improving treatment outcomes for stroke patients in these areas. While this approach has been widely adopted in many developed countries, its efficacy in guiding basic-level hospitals to manage acute ischemic stroke requires further investigation through large-scale, high-quality studies.
This study focused on patients with acute ischemic stroke who sought treatment at basic-level hospitals, aiming to investigate the efficacy and safety of treating acute ischemic stroke with telemedicine-supported management. Hospitals assigned to the experimental group received remote consultation guidance, quality control and professional training from expert teams at leading stroke centers, China National Center for Neurological Disorders. Hospitals in the control group did not receive telemedicine-supported management.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Telemedicine-Supported Group | Experimental | Receive remote guidance from expert stroke centers for treatment of patients with intravenous thrombolysis, along with quality control for standardized workflow support, and professional training. |
|
| Standard Treatment Group without Telemedicine-Supported Management | No Intervention | Control-group patients will receive routine stroke care at their primary care hospitals, with no remote consultation, study-related quality control, or extra training. Care will follow the hospitals' usual protocols, including emergency assessment, neurological evaluation, imaging, and intravenous thrombolysis. Hospitals may continue their regular stroke-related training during the study to reflect real-world practice. |
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Telemedicine-Supported Management | Other | Receive round-the-clock 7×24h remote consultation guidance from expert teams at leading stroke centers, covering patient triage and initial assessment, thrombolysis decision-making, and treatment guidance. Undergo quality control for standardized workflow implementation, and professional training. |
| Measure | Description | Time Frame |
|---|---|---|
| Proportion of patients with mRS scores of 0-1 | 90 days |
| Measure | Description | Time Frame |
|---|---|---|
| Intravenous thrombolysis rate | 4.5 hours | |
| mRS score | Ranges from 0 to 6 points, with lower scores indicating better functional outcome. | 90 days |
| Measure | Description | Time Frame |
|---|---|---|
| Proportion of sICH | The time frame is within 36 hours after thrombolysis in patients. Symptomatic intracranial hemorrhage occurring during this period is considered an endpoint event. If the patient is discharged within 36 hours, the endpoint event is observed during the hospitalization period. | Within 36 hours of thrombolysis |
Inclusion Criteria:
Hospital Inclusion Criteria:
Patient Inclusion Criteria:
Exclusion Criteria:
Hospital Exclusion Criteria:
Patient Exclusion Criteria:
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| Name | Role | Phone | Extension | |
|---|---|---|---|---|
| Xunming Ji | Contact | 01083198962 | jixm@ccmu.edu.cn | |
| Chuanjie Wu | Contact | 01083199439 | wuchuanjie@ccmu.edu.cn |
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| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Xuanwu Hospital | Recruiting | Beijing | Beijing Municipality | 100053 | China |
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| ID | Term |
|---|---|
| D000083242 | Ischemic Stroke |
| ID | Term |
|---|---|
| D020521 | Stroke |
| D002561 | Cerebrovascular Disorders |
| D001927 | Brain Diseases |
| D002493 | Central Nervous System Diseases |
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| Door-to-(thrombolysis)needle-time | The time calculation begins when the patient arrives at the hospital and ends upon receiving thrombolytic therapy. The theoretical range is 0 to 270 minutes. | 4.5 hours |
| Rate of endovascular therapy receipt among eligible patients | 24 hours |
| Proportion of any type of ICH |
The time frame is within 36 hours of thrombolysis administration. Any type of intracerebral hemorrhage occurring during this period is considered an endpoint event. If the patient is discharged within 36 hours, the endpoint event is observed during the hospitalization period. |
| Within 36 hours of thrombolysis |
| All-cause mortality rate | 90 days |
| D009422 |
| Nervous System Diseases |
| D014652 | Vascular Diseases |
| D002318 | Cardiovascular Diseases |