Acute Ischemic StrokeLMVOSNCT06125236
Registration of Acute Ischemic Stroke With Large and Medium-sized Vascular Occlusion in Southwest China(LMVOS)
An observational study of Acute Ischemic Stroke, run by Zhengzhou Yuan 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
- 8,000 participants
- Where
- 1 siteChina
- Study dates
- 9 Nov 2023to 1 May 2046
- 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
Affiliated Hospital of Southwest Medical University
Luzhou, 646000
Zhengzhou Yuan, +868303165661
About this study
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
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.
- Conditions
- Acute Ischemic Stroke
- Being tested
- Visit at D90
- 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
Time from the arrival of stroke patient in emergency to initiation of thrombolysis therapy.
Measured: 24 hours
Door-to-Puncture Time (DPT)
ime 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 posted9 Nov 2023
- Study start9 Nov 2023
- Primary completion1 Dec 2045 (estimated)
- Study completion1 May 2046 (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
- 8,000 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Zhengzhou Yuan
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor-investigator, Zhengzhou Yuan, The Affiliated Hospital Of Southwest Medical University
- Investigators
- Zhengzhou Yuan, MD, Study chair, Department of Neurology, Affiliated Hospital of Southwest Medical University, LuZhou, China.
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06125236
- Sponsor's protocol ID
- SWMU202309
- Acronym
- LMVOS
- Status last verified
- Nov 2023
- First submitted
- 6 Nov 2023
- Last updated
- 13 Nov 2023
- Results posted
- No
- 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 13 Nov 2023. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Registration of Acute Ischemic Stroke With Large and Medium-sized Vascular Occlusion in Southwest China(LMVOS)
- ClinicalTrials.gov ID
- NCT06125236
- Acronym / sponsor ID
- LMVOS / SWMU202309
- Conditions
- Acute Ischemic Stroke
- Study type
- Observational
- Recruitment status
- Recruiting
- Enrolment
- 8,000 participants (estimated)
- Lead sponsor
- Zhengzhou YuanUniversity, hospital or other
- Study start
- 9 Nov 2023 (actual)
- Primary completion
- 1 Dec 2045 (estimated)
- Study completion
- 1 May 2046 (estimated)
- First posted
- 9 Nov 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
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 design
- Observational model
- Cohort
- Time perspective
- Prospective
- 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
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 13 Nov 2023.
- 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.
Zhengzhou Yuan, MD study chair
Department of Neurology, Affiliated Hospital of Southwest Medical University, LuZhou, China.
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 Zhengzhou Yuan 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 13 Nov 2023. 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 Zhengzhou Yuan, MD (+868303165661, coneuro@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 13 Nov 2023.