Registry of Acute Ischemic Stroke With Large- or Medium-vessel Occlusion

Study Overview
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Brief Summary
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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.

Detailed Description
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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.

Official Title
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The Multicenter, Prospective, Real-world Registry of Acute Ischemic Stroke With Large- or Medium-vessel Occlusion

Conditions
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Acute Ischemic Stroke

Intervention / Treatment
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* Other: Visit at D90


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: The clinical diagnosis is acute ischemic stroke with large- or medium- vessel occlusion (the criteria followed the Chinese Guidelines for the Diagnosis and Treatment of Acute Ischemic Stroke 2018) Informed consent from the patient or surrogate Exclusion Criteria: No additional exclusion criteria
Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| acute ischemic stroke with large- or medium-vessel occlusion<br>acute ischemic stroke patients with large- or medium-vessel occlusion including all treatments. | Other: Visit at D90<br>* Visits at 90±7 days after stroke onset were conducted by trained and blinded investigators, with face-to-face, telephone call or Internet access.<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | 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 | 

Secondary Outcome Measures

| Outcome Measure | 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. | 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 | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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acute ischemic stroke, large vessel occlusion, medium vessel occlusion, real-world registry