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

May 28, 2024 updated by: Junwei Hao, MD, Xuanwu Hospital, Beijing

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

Status

Indicates the current recruitment status or the expanded access status.
Recruiting

Conditions

Conditions

The disease, disorder, syndrome, illness, or injury that is being studied. On ClinicalTrials.gov, conditions may also include other health-related issues, such as lifespan, quality of life, and health risks.

Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.

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

Study Type

Describes the nature of a clinical study. Study types include interventional studies (also called clinical trials), observational studies (including patient registries), and expanded access.
Observational

Enrollment (Estimated)

Enrollment

The number of participants in a clinical study. The "anticipated" enrollment is the target number of participants that the researchers need for the study.
50000

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

Study Contact

The name and contact information for the person who can answer enrollment questions for a clinical study. Each location where the study is being conducted may also have a specific contact, who may be better able to answer those questions.

Study Contact Backup

Study Locations

  • China
    • Beijing
      • Beijing, Beijing, China, 100053
        • Recruiting
        • Xuanwu Hospital, Capital Medical University
        • Contact:
        • Contact:

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Eligibility Criteria

The key requirements that people who want to participate in a clinical study must meet or the characteristics they must have. Eligibility criteria consist of both inclusion criteria (which are required for a person to participate in the study) and exclusion criteria (which prevent a person from participating). Types of eligibility criteria include whether a study accepts healthy volunteers, has age or age group requirements, or is limited by sex.

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

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

Cohorts and Interventions

Group / Cohort

Group / Cohort

A group or subgroup of participants in an observational study that is assessed for biomedical or health outcomes.
Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.
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

Primary Outcome Measures

In a clinical study's protocol, the planned outcome measure that is the most important for evaluating the effect of an intervention/treatment. Most clinical studies have one primary outcome measure, but some have more than one.
Outcome Measure
Measure Description
Time Frame
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)
90±7 days

Secondary Outcome Measures

Secondary Outcome Measures

In a clinical study's protocol, a planned outcome measure that is not as important as the primary outcome measure for evaluating the effect of an intervention but is still of interest. Most clinical studies have more than one secondary outcome measure.
Outcome Measure
Measure Description
Time Frame
Excellent functional outcome
Time Frame: 90±7 days
Proportion of subjects with mRS 0-1 at 90±7 days.
90±7 days
Good functional outcome
Time Frame: 90±7 days
Proportion of subjects with mRS 0-2 at 90±7 days.
90±7 days
mRS 0-3
Time Frame: 90±7 days
Proportion of subjects with mRS 0-3 at 90±7 days.
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, 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)
Time Frame: 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.
7 days
Symptom-to-thrombolysis time (STT)
Time Frame: 24 hours
Time from onset of symptoms to thrombolytic therapy.
24 hours
Door-to-Needle Time (DNT)
Time Frame: 24 hours
Time from the arrival of stroke patient in emergency to initiation of thrombolysis therapy.
24 hours
Door-to-Puncture Time (DPT)
Time Frame: 24 hours
Time from the arrival of stroke patient in emergency to groin puncture.
24 hours
Onset-to-recanalization time
Time Frame: 24 hours
Time from symptom onset to the beginning of recanalization (recanalization defined as expanded TICI scale≥2b).
24 hours
Door-to-Recanalization Time (DRT)
Time Frame: 24 hours
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 Frame: 24 hours
Time from groin puncture to recanalization (recanalization defined as expanded TICI scale≥2b).
24 hours

Other Outcome Measures

Other Outcome Measures

For clinical trials, a planned measurement described in the protocol that is used to determine the effect of an intervention/treatment on participants. For observational studies, a measurement or observation that is used to describe patterns of diseases or traits, or associations with exposures, risk factors, or treatment. Types of outcome measures include primary outcome measure and secondary outcome measure.
Outcome Measure
Measure Description
Time Frame
Incidence of any intracranial hemorrhage
Time Frame: 36 hours
Incidence of any intracranial hemorrhage (Heidelberg criteria) measured at 36 hours
36 hours
Incidence of clinically significant intracranial hemorrhage
Time Frame: 36 hours
Incidence of sICH (Heidelberg criteria) measured at 36 hours
36 hours
All-cause mortality
Time Frame: 90±7 days
All-cause mortality at 90±7 days
90±7 days
Complications related to intravenous thrombolysis
Time Frame: up to 7 days
Complications related to intravenous thrombolysis during hospitalization
up to 7 days
Complications related to endovascular treatment
Time Frame: up to 7 days
Complications related to intravenous thrombolysis during hospitalization
up to 7 days

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Sponsor

The organization or person who initiates the study and who has authority and control over the study.
Xuanwu Hospital, Beijing

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

Study Start

The actual date on which the first participant was enrolled in a clinical study. The "anticipated" study start date is the date that the researchers think will be the study start date.
April 25, 2023

Primary Completion (Estimated)

Primary Completion

The date on which the last participant in a clinical study was examined or received an intervention to collect final data for the primary outcome measure. Whether the clinical study ended according to the protocol or was terminated does not affect this date. For clinical studies with more than one primary outcome measure with different completion dates, this term refers to the date on which data collection is completed for all the primary outcome measures. The "anticipated" primary completion date is the date that the researchers think will be the primary completion date for the study.
April 30, 2032

Study Completion (Estimated)

Study Completion

The date on which the last participant in a clinical study was examined or received an intervention/treatment to collect final data for the primary outcome measures, secondary outcome measures, and adverse events (that is, the last participant's last visit). The "anticipated" study completion date is the date that the researchers think will be the study completion date.
December 30, 2032

Study Registration Dates

First Submitted

First Submitted

The date on which the study sponsor or investigator first submitted a study record to ClinicalTrials.gov. There is typically a delay of a few days between the first submitted date and the record's availability on ClinicalTrials.gov (the first posted date).
March 7, 2023

First Submitted That Met QC Criteria

First Submitted That Met QC Criteria

The date on which the study sponsor or investigator first submits a study record that is consistent with National Library of Medicine (NLM) quality control (QC) review criteria. The sponsor or investigator may need to revise and submit a study record one or more times before NLM's QC review criteria are met. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
March 19, 2023

First Posted (Actual)

First Posted

The date on which the study record was first available on ClinicalTrials.gov after National Library of Medicine (NLM) quality control (QC) review has concluded. There is typically a delay of a few days between the date the study sponsor or investigator submitted the study record and the first posted date.
March 22, 2023

Study Record Updates

Last Update Posted (Actual)

Last Update Posted

The most recent date on which changes to a study record were made available on ClinicalTrials.gov. There may be a delay between when the changes were submitted to ClinicalTrials.gov by the study's sponsor or investigator (the last update submitted date) and the last update posted date.
May 30, 2024

Last Update Submitted That Met QC Criteria

Last Update Submitted That Met QC Criteria

The most recent date on which the study sponsor or investigator submitted changes to a study record that are consistent with National Library of Medicine (NLM) quality control (QC) review criteria. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
May 28, 2024

Last Verified

Last Verified

The most recent date on which the study sponsor or investigator confirmed the information about a clinical study on ClinicalTrials.gov as accurate and current. If a study with a recruitment status of recruiting; not yet recruiting; or active, not recruiting has not been confirmed within the past 2 years, the study's recruitment status is shown as unknown.
May 1, 2024

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

Other Study ID Numbers

Identifiers or ID numbers other than the NCT number that are assigned to a clinical study by the study's sponsor, funders, or others. These numbers may include unique identifiers from other trial registries and National Institutes of Health grant 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

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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