Registration of Acute Ischemic Stroke With Large and Medium-sized Vascular Occlusion in Southwest China(LMVOS)
Study Details
Study Description
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.
| Condition or Disease | Intervention/Treatment | Phase |
|---|---|---|
|
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.
Study Design
Arms and Interventions
| Arm | Intervention/Treatment |
|---|---|
| Acute ischemic stroke with large- or medium-vessel occlusion Acute ischemic stroke patients with large- or medium-vessel occlusion including all treatments. |
Other: Visit at D90
Visits at 90±7 days after stroke onset were conducted by trained and blinded investigators, with face-to-face, telephone call or Internet access.
|
Outcome Measures
Primary Outcome Measures
- 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 Outcome Measures
- 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.
- 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.
- Change of National Institutes of Health Stroke Scale (NIHSS) [7 days]
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.
- Symptom-to-thrombolysis time (STT) [24 hours]
Time from onset of symptoms to thrombolytic therapy.
- 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).
Other Outcome Measures
- Incidence of clinically significant intracranial hemorrhage [36 hours]
Incidence of sICH (Heidelberg criteria) measured at 36 hours
- Incidence of any intracranial hemorrhage [36 hours]
Incidence of any intracranial hemorrhage (Heidelberg criteria) measured at 36 hours
- 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
Eligibility Criteria
Criteria
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.
Contacts and Locations
Locations
| Site | City | State | Country | Postal Code | |
|---|---|---|---|---|---|
| 1 | Affiliated Hospital of Southwest Medical University | Luzhou | China | 646000 |
Sponsors and Collaborators
- Zhengzhou Yuan
Investigators
- Study Chair: Zhengzhou Yuan, MD, Department of Neurology, Affiliated Hospital of Southwest Medical University, LuZhou, China.
Study Documents (Full-Text)
None provided.More Information
Publications
None provided.- SWMU202309