Acute Ischemic Stroke
Conditions
Brief summary
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
LMVOS is a prospective, real-world registry lasting for 22 years. A total of 8000 patients with large- or medium-vessel occlusion will be enrolled.
Interventions
Visits at 90±7 days after stroke onset were conducted by trained and blinded investigators, with face-to-face, telephone call or Internet access.
Sponsors
Study design
Eligibility
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
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| modified Rankin Scale (mRS) score | 90±7 days | 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) |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Change of National Institutes of Health Stroke Scale (NIHSS) | 24 hours | 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. |
| Door-to-Needle Time | 24 hours | Time from the arrival of stroke patient in emergency to initiation of thrombolysis therapy. |
| Door-to-Puncture Time (DPT) | 24 hours | ime from the arrival of stroke patient in emergency to groin puncture. |
| Onset-to-recanalization time | 24 hours | Time from symptom onset to the beginning of recanalization (recanalization defined as expanded TICI scale≥2b). |
| Door-to-Recanalization Time (DRT) | 24 hours | Time from the arrival of stroke patient in emergency to the beginning of recanalization (recanalization defined as expanded TICI scale≥2b). |
| Puncture-to-recanalization time | 24 hours | Time from groin puncture to recanalization (recanalization defined as expanded TICI scale≥2b). |
| Excellent functional outcome | 90±7 days | Proportion of subjects with mRS 0-1 at 90±7 days. |
| Good functional outcome | 90±7 days | Proportion of subjects with mRS 0-2 at 90±7 days. |
| mRS 0-3 | 90±7 days | Proportion of subjects with mRS 0-3 at 90±7 days. |
| Symptom-to-thrombolysis time (STT) | 24 hours | Time from onset of symptoms to thrombolytic therapy. |
Other
| Measure | Time frame | Description |
|---|---|---|
| All-cause mortality | 90±7 days | All-cause mortality at 90±7 days |
| Complications related to intravenous thrombolysis | up to 7 days | Complications related to intravenous thrombolysis during hospitalization |
| Complications related to endovascular treatment | up to 7 days | Complications related to intravenous thrombolysis during hospitalization |
| Incidence of any intracranial hemorrhage | 36 hours | Incidence of any intracranial hemorrhage (Heidelberg criteria) measured at 36 hours |
| Incidence of clinically significant intracranial hemorrhage | 36 hours | Incidence of sICH (Heidelberg criteria) measured at 36 hours |
Countries
China