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This study is designed to observe the treatment options in real-world clinical practice as well as the safety and efficacy of different treatment strategies.
LOMEVO is a prospective, multicenter, real-world registry lasting for 10 years. A total of 50000 patients with large- or medium-vessel occlusion will be enrolled at approximately 30 centers around China.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| acute ischemic stroke with large- or medium-vessel occlusion | acute ischemic stroke patients with large- or medium-vessel occlusion including all treatments. |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Visit at D90 | Other | Visits at 90±7 days after stroke onset were conducted by trained and blinded investigators, with face-to-face, telephone call or Internet access. |
|
| Measure | Description | Time Frame |
|---|---|---|
| modified Rankin Scale (mRS) score | Ordinal distribution of mRS at 90±7 days; modified Rankin scale (range, 0 to 6, with a score of 0 indicating no disability, 1 no clinically significant disability, 2 slight disability, 3 moderate disability but remaining able to walk unassisted, 4 moderately severe disability, 5 severe disability, and 6 death) | 90±7 days |
| Measure | Description | Time Frame |
|---|---|---|
| Excellent functional outcome | Proportion of subjects with mRS 0-1 at 90±7 days. | 90±7 days |
| Good functional outcome | Proportion of subjects with mRS 0-2 at 90±7 days. |
| Measure | Description | Time Frame |
|---|---|---|
| Incidence of clinically significant intracranial hemorrhage | Incidence of sICH (Heidelberg criteria) measured at 36 hours | 36 hours |
| Incidence of any intracranial hemorrhage | Incidence of any intracranial hemorrhage (Heidelberg criteria) measured at 36 hours |
Inclusion Criteria:
Exclusion Criteria:
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Patients with acute ischemic stroke due to large- or medium-vessel occlusion will be enrolled and no additional exclusion criteria are set.
| Name | Role | Phone | Extension | |
|---|---|---|---|---|
| Junwei Hao, MD; PhD | Contact | 01083198277 | haojunwei@vip.163.com | |
| Gaoting Ma, MD | Contact | 18301579891 | demo_doctor@163.com |
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| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Xuanwu Hospital, Capital Medical University | 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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| 90±7 days |
| mRS 0-3 | Proportion of subjects with mRS 0-3 at 90±7 days. | 90±7 days |
| Change of National Institutes of Health Stroke Scale (NIHSS) | Change of National Institutes of Health Stroke Scale (NIHSS, a scale between 0 and 42 on which higher scores indicate more severe neurologic deficits) from baseline to 24 hours. | 24 hours |
| Change of National Institutes of Health Stroke Scale (NIHSS) | Change of National Institutes of Health Stroke Scale (NIHSS, a scale between 0 and 42 on which higher scores indicate more severe neurologic deficits) from baseline to 7 days. | 7 days |
| Symptom-to-thrombolysis time (STT) | Time from onset of symptoms to thrombolytic therapy. | 24 hours |
| Door-to-Needle Time (DNT) | Time from the arrival of stroke patient in emergency to initiation of thrombolysis therapy. | 24 hours |
| Door-to-Puncture Time (DPT) | Time from the arrival of stroke patient in emergency to groin puncture. | 24 hours |
| Onset-to-recanalization time | Time from symptom onset to the beginning of recanalization (recanalization defined as expanded TICI scale≥2b). | 24 hours |
| Door-to-Recanalization Time (DRT) | Time from the arrival of stroke patient in emergency to the beginning of recanalization (recanalization defined as expanded TICI scale≥2b). | 24 hours |
| Puncture-to-recanalization time | Time from groin puncture to recanalization (recanalization defined as expanded TICI scale≥2b). | 24 hours |
| 36 hours |
| All-cause mortality | All-cause mortality at 90±7 days | 90±7 days |
| Complications related to intravenous thrombolysis | Complications related to intravenous thrombolysis during hospitalization | up to 7 days |
| Complications related to endovascular treatment | Complications related to intravenous thrombolysis during hospitalization | up to 7 days |
| D009422 |
| Nervous System Diseases |
| D014652 | Vascular Diseases |
| D002318 | Cardiovascular Diseases |