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

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

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.

Study Overview

• Status: Recruiting
• Conditions: Acute Ischemic Stroke
• Intervention / Treatment: Other: Visit at D90

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 Type: Observational
• Enrollment (Estimated): 50000

Contacts and Locations

• Study Contact: Name: Gaoting Ma, MD; Phone Number: 18301579891; Email: demo_doctor@163.com
• Study Contact Backup: Name: Junwei Hao, MD; PhD; Phone Number: 01083198277; Email: haojunwei@vip.163.com

Study Locations

• China
  • Beijing
    • Beijing, Beijing, China, 100053
      • Recruiting
      • Xuanwu Hospital, Capital Medical University
      • Contact: Gaoting Ma, MD; Phone Number: 18301579891; Email: demo_doctor@163.com
      • Contact: Junwei Hao, MD; PhD; Phone Number: 01083198277; Email: haojunwei@vip.163.com

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Child; Adult; Older Adult
• Accepts Healthy Volunteers: No

• Sampling Method: Non-Probability Sample

Study Population

Patients with acute ischemic stroke due to large- or medium-vessel occlusion will be enrolled and no additional exclusion criteria are set.

Description

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 Plan

How is the study designed?

Number of groups / cohorts

1

Cohorts and Interventions

Group / Cohort	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.

What is the study measuring?

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

Other Outcome Measures

Outcome Measure	Measure Description	Time Frame
Incidence of any intracranial hemorrhage	Incidence of any intracranial hemorrhage (Heidelberg criteria) measured at 36 hours	36 hours
Incidence of clinically significant intracranial hemorrhage	Incidence of sICH (Heidelberg criteria) measured at 36 hours	36 hours
All-cause mortality	All-cause mortality at 90±7 days	90±7 days
Complications related to intravenous thrombolysis	Complications related to intravenous thrombolysis during hospitalization	up to 7 days
Complications related to endovascular treatment	Complications related to intravenous thrombolysis during hospitalization	up to 7 days

Collaborators and Investigators

• Sponsor: Xuanwu Hospital, Beijing

Study record dates

Study Major Dates

• Study Start (Actual): April 25, 2023
• Primary Completion (Estimated): April 30, 2032
• Study Completion (Estimated): December 30, 2032

Study Registration Dates

• First Submitted: March 7, 2023
• First Submitted That Met QC Criteria: March 19, 2023
• First Posted (Actual): March 22, 2023

Study Record Updates

• Last Update Posted (Actual): May 30, 2024
• Last Update Submitted That Met QC Criteria: May 28, 2024
• Last Verified: May 1, 2024

More Information

Terms related to this study

• Keywords: acute ischemic stroke; large vessel occlusion; medium vessel occlusion; real-world registry
• Additional Relevant MeSH Terms: Pathologic Processes; Necrosis; Cardiovascular Diseases; Vascular Diseases; Cerebrovascular Disorders; Brain Diseases; Central Nervous System Diseases; Nervous System Diseases; Brain Ischemia; Infarction; Brain Infarction; Stroke; Ischemic Stroke; Ischemia; Cerebral Infarction
• Other Study ID Numbers: XMEC-2023-002

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No