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

Recruiting

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

• Registration Number: NCT05779215
• Lead Sponsor: Xuanwu Hospital, Beijing

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

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.

Study Timeline

• Study First Submitted: 2023-03-07
• Study First Submitted QC: 2023-03-19
• Study First Posted: 2023-03-22
• Study Start: 2023-04-25
• Status Verified: 2024-05
• Last Update Submitted: 2024-05-28
• Last Update Posted: 2024-05-30
• Primary Completion: 2032-04-30
• Study Completion: 2032-12-30

Recruitment & Eligibility

• Status: RECRUITING
• Sex: All
• Target Recruitment: 50000

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
mRS 0-3	90±7 days	Proportion of subjects with mRS 0-3 at 90±7 days.
Excellent functional outcome	90±7 days	Proportion of subjects with mRS 0-1 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.
Door-to-Puncture Time (DPT)	24 hours	Time from the arrival of stroke patient in emergency to groin puncture.
Good functional outcome	90±7 days	Proportion of subjects with mRS 0-2 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).
Symptom-to-thrombolysis time (STT)	24 hours	Time from onset of symptoms to thrombolytic therapy.
Door-to-Needle Time (DNT)	24 hours	Time from the arrival of stroke patient in emergency to initiation of thrombolysis therapy.
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)

Xuanwu Hospital, Capital Medical University; 🇨🇳 Beijing, Beijing, China