Acute Ischemic StrokeLOMEVONCT05779215
Registry of Acute Ischemic Stroke With Large- or Medium-vessel Occlusion
An observational study of Acute Ischemic Stroke, run by Xuanwu Hospital, Beijing at 1 site in China.
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. Read more about this study
- Who is it for?
- Any age
- Conditions the study is for
- Acute Ischemic Stroke
- What is being tested?
- Visit at D90
- How many people
- 50,000 participants
- Where
- 1 siteChina
- Study dates
- 25 Apr 2023to 30 Dec 2032
- How long will I take part?
- 90 Days
- Phase
- Observational
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages Any age
- All sexes
- No healthy volunteers
- Child, Adult, Older adult
Study population: Patients with acute ischemic stroke due to large- or medium-vessel occlusion will be enrolled and no additional exclusion criteria are set.
Who may be able to join
- 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
Who cannot join
- No additional exclusion criteria
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
China1 site, 1 recruiting
- Recruiting
Xuanwu Hospital, Capital Medical University
Beijing, Beijing Municipality, 100053
Junwei Hao, MD; PhD, 01083198277, haojunwei@vip.163.com
Gaoting Ma, MD, 18301579891, demo_doctor@163.com
About this study
Official title: 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.
Read the 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.
- Conditions
- Acute Ischemic Stroke
- Being tested
- Visit at D90
- Keywords
- acute ischemic stroke, large vessel occlusion, medium vessel occlusion, real-world registry
- Medical subject headings
- Ischemic Stroke
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Visit at D90Other
Visits at 90±7 days after stroke onset were conducted by trained and blinded investigators, with face-to-face, telephone call or Internet access.
| Study group | Role | What they receive |
|---|---|---|
| acute ischemic stroke with large- or medium-vessel occlusion | acute ischemic stroke patients with large- or medium-vessel occlusion including all treatments. Receives: Other: Visit at D90 |
What is being measured
The primary outcome is the main question the study is designed to answer.
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)
Measured: 90±7 days
Secondary outcomes (11)
Excellent functional outcome
Proportion of subjects with mRS 0-1 at 90±7 days.
Measured: 90±7 days
Good functional outcome
Proportion of subjects with mRS 0-2 at 90±7 days.
Measured: 90±7 days
mRS 0-3
Proportion of subjects with mRS 0-3 at 90±7 days.
Measured: 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.
Measured: 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.
Measured: 7 days
Symptom-to-thrombolysis time (STT)
Time from onset of symptoms to thrombolytic therapy.
Measured: 24 hours
Door-to-Needle Time (DNT)
Time from the arrival of stroke patient in emergency to initiation of thrombolysis therapy.
Measured: 24 hours
Door-to-Puncture Time (DPT)
Time from the arrival of stroke patient in emergency to groin puncture.
Measured: 24 hours
Onset-to-recanalization time
Time from symptom onset to the beginning of recanalization (recanalization defined as expanded TICI scale≥2b).
Measured: 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).
Measured: 24 hours
Puncture-to-recanalization time
Time from groin puncture to recanalization (recanalization defined as expanded TICI scale≥2b).
Measured: 24 hours
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted22 Mar 2023
- Study start25 Apr 2023
- Primary completion30 Apr 2032 (estimated)
- Study completion30 Dec 2032 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Acute Ischemic StrokeStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Cohort
- Time perspective
- Prospective
- Enrolment
- 50,000 participants (estimated)
- Target duration
- 90 Days
Sponsor and investigators
- Lead sponsor
- Xuanwu Hospital, Beijing
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Junwei Hao, MD, Xuanwu Hospital, Beijing
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05779215
- Sponsor's protocol ID
- XMEC-2023-002
- Acronym
- LOMEVO
- Status last verified
- May 2024
- First submitted
- 7 Mar 2023
- Last updated
- 30 May 2024
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 30 May 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- The Multicenter, Prospective, Real-world Registry of Acute Ischemic Stroke With Large- or Medium-vessel Occlusion
- ClinicalTrials.gov ID
- NCT05779215
- Acronym / sponsor ID
- LOMEVO / XMEC-2023-002
- Conditions
- Acute Ischemic Stroke
- Keywords
- acute ischemic stroke, large vessel occlusion, medium vessel occlusion, real-world registry
- Study type
- Observational
- Recruitment status
- Recruiting
- Enrolment
- 50,000 participants (estimated)
- Lead sponsor
- Xuanwu Hospital, BeijingUniversity, hospital or other
- Study start
- 25 Apr 2023 (actual)
- Primary completion
- 30 Apr 2032 (estimated)
- Study completion
- 30 Dec 2032 (estimated)
- First posted
- 22 Mar 2023 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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 design
- Observational model
- Cohort
- Time perspective
- Prospective
- Target follow-up
- 90 Days
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| acute ischemic stroke with large- or medium-vessel occlusion | – | Other: Visit at D90acute ischemic stroke patients with large- or medium-vessel occlusion including all treatments. |
Who may qualify
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult, Older adult
- Study population
- Patients with acute ischemic stroke due to large- or medium-vessel occlusion will be enrolled and no additional exclusion criteria are set.
Key inclusion criteria (2 listed)
- 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
Key exclusion criteria (1 listed)
- No additional exclusion criteria
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Visit at D90Visits at 90±7 days after stroke onset were conducted by trained and blinded investigators, with face-to-face, telephone call or Internet access. | Other | acute ischemic stroke with large- or medium-vessel occlusion |
Primary outcome
modified Rankin Scale (mRS) score
Time frame: 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)
11 secondary outcomes
Excellent functional outcome
Time frame: 90±7 days
Good functional outcome
Time frame: 90±7 days
mRS 0-3
Time frame: 90±7 days
Change of National Institutes of Health Stroke Scale (NIHSS)
Time frame: 24 hours
Change of National Institutes of Health Stroke Scale (NIHSS)
Time frame: 7 days
Symptom-to-thrombolysis time (STT)
Time frame: 24 hours
Door-to-Needle Time (DNT)
Time frame: 24 hours
Door-to-Puncture Time (DPT)
Time frame: 24 hours
Onset-to-recanalization time
Time frame: 24 hours
Door-to-Recanalization Time (DRT)
Time frame: 24 hours
Puncture-to-recanalization time
Time frame: 24 hours
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 30 May 2024.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Acute Ischemic Stroke, run by Xuanwu Hospital, Beijing at 1 site in China.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 2 inclusion and 1 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: looking for participants now, as of the sponsor's last update on 30 May 2024. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in China. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Junwei Hao, MD; PhD (01083198277, haojunwei@vip.163.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
modified Rankin Scale (mRS) score (time frame: 90±7 days). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 30 May 2024; AzTrials last refreshed its copy on 26 Oct 2026.