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

Acute Ischemic Stroke Clinical Trial

— LOMEVO  

Official title:

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

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT05779215
• Other study ID #: XMEC-2023-002
• Status: Recruiting
• Start date: April 25, 2023
• Est. completion date: December 30, 2032

Study information

• Verified date: May 2024
• Source: Xuanwu Hospital, Beijing
• Contact: Junwei Hao, MD; PhD
• Phone: 01083198277
• Email: haojunwei[@]vip.163.com
• Is FDA regulated: No
• Study type: Observational [Patient Registry]

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 50000
• Est. completion date: December 30, 2032
• Est. primary completion date: April 30, 2032
• Accepts healthy volunteers: No
• Gender: All
• Age group: N/A and older

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 exclusion criteria

Related Conditions & MeSH terms

• Acute Ischemic Stroke
• Cerebral Infarction
• Ischemia
• Ischemic Stroke
• Stroke

Intervention

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.

Locations

Country	Name	City	State
China	Xuanwu Hospital, Capital Medical University	Beijing	Beijing

Sponsors (1)

Lead Sponsor	Collaborator
Xuanwu Hospital, Beijing

Country where clinical trial is conducted

China, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Other	Incidence of clinically significant intracranial hemorrhage	Incidence of sICH (Heidelberg criteria) measured at 36 hours	36 hours
Other	Incidence of any intracranial hemorrhage	Incidence of any intracranial hemorrhage (Heidelberg criteria) measured at 36 hours	36 hours
Other	All-cause mortality	All-cause mortality at 90±7 days	90±7 days
Other	Complications related to intravenous thrombolysis	Complications related to intravenous thrombolysis during hospitalization	up to 7 days
Other	Complications related to endovascular treatment	Complications related to intravenous thrombolysis during hospitalization	up to 7 days
Primary	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	Excellent functional outcome	Proportion of subjects with mRS 0-1 at 90±7 days.	90±7 days
Secondary	Good functional outcome	Proportion of subjects with mRS 0-2 at 90±7 days.	90±7 days
Secondary	mRS 0-3	Proportion of subjects with mRS 0-3 at 90±7 days.	90±7 days
Secondary	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
Secondary	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
Secondary	Symptom-to-thrombolysis time (STT)	Time from onset of symptoms to thrombolytic therapy.	24 hours
Secondary	Door-to-Needle Time (DNT)	Time from the arrival of stroke patient in emergency to initiation of thrombolysis therapy.	24 hours
Secondary	Door-to-Puncture Time (DPT)	Time from the arrival of stroke patient in emergency to groin puncture.	24 hours
Secondary	Onset-to-recanalization time	Time from symptom onset to the beginning of recanalization (recanalization defined as expanded TICI scale=2b).	24 hours
Secondary	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
Secondary	Puncture-to-recanalization time	Time from groin puncture to recanalization (recanalization defined as expanded TICI scale=2b).	24 hours