Registration of Acute Ischemic Stroke With Large and Medium-sized Vascular Occlusion in Southwest China(LMVOS)

Recruiting

• Conditions: Acute Ischemic Stroke
• Interventions: Other: Visit at D90

• Registration Number: NCT06125236
• Lead Sponsor: Zhengzhou Yuan

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.

Study Timeline

• Status Verified: 2023-11
• Study First Submitted: 2023-11-06
• Study First Submitted QC: 2023-11-06
• Study Start: 2023-11-09
• Study First Posted: 2023-11-09
• Last Update Submitted: 2023-11-09
• Last Update Posted: 2023-11-13
• Primary Completion: 2045-12-01
• Study Completion: 2046-05-01

Recruitment & Eligibility

• Status: RECRUITING
• Sex: All
• Target Recruitment: 8000

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.

Study & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Arm && Interventions

Group	Intervention	Description
Acute ischemic stroke with large- or medium-vessel occlusion	Visit at D90	Acute ischemic stroke patients with large- or medium-vessel occlusion including all treatments.

Primary Outcome Measures

Name	Time	Method
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

Name	Time	Method
Excellent functional outcome	90±7 days	Proportion of subjects with mRS 0-1 at 90±7 days.
Onset-to-recanalization time	24 hours	Time from symptom onset to the beginning of recanalization (recanalization defined as expanded TICI scale≥2b).
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)	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.
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).

Trial Locations

Locations (1)

Affiliated Hospital of Southwest Medical University; 🇨🇳 Luzhou, China