Effect of Acupoint Stimulation on Lactate During Cerebral Endovascular Intervention (ASLA)

January 13, 2025 updated by: Zhihong LU, Air Force Military Medical University, China

The Effect of Acupoint Stimulation on Level of Lactate in Patients Undergoing Cerebral Endovascular Intervention

It is advocated that neuroprotection should be increased before endovascular treatment and that the penumbra should be protected from reperfusion damage after recanalization. Monitoring lactate and pH levels in acute ischemic stroke patients who have had endovascular recanalization can be utilized to predict mortality and morbidity, especially in the first five hours after the procedure. This study aims to observe the effect of acupoint stimulation on lactate level during endovascular recanalization.

Study Overview

Status

Status

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

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.

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.
Interventional

Enrollment (Actual)

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.
28

Phase

Phase

The stage of a clinical trial studying a drug or biological product, based on definitions developed by the U.S. Food and Drug Administration (FDA). The phase is based on the study's objective, the number of participants, and other characteristics. There are five phases: Early Phase 1 (formerly listed as Phase 0), Phase 1, Phase 2, Phase 3, and Phase 4. Not Applicable is used to describe trials without FDA-defined phases, including trials of devices or behavioral interventions.
  • Not Applicable

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 Locations

  • China
    • Shaanxi
      • Xi'an, Shaanxi, China
        • the First Affiliated Hospital of the Air Force Military Medical University

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

  • Adult
  • Older Adult

Accepts Healthy Volunteers

No

Description

Inclusion Criteria:

  • age ≥18 years
  • scheduled for cerebral endovascular intervention

Exclusion Criteria:

  • American Society of Anesthesiologists status over level three
  • history of cerebral vascular intervention
  • history of severe neurological disease (stroke, neurological degenerative disease, psychiatric disease)
  • severe hepatic or renal dysfunction
  • severe glucose disorder or thyroid dysfunction
  • contraindications to transcutaneous electrical stimulation (infection or injury of the skin area, implanted electrical devices)

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

  • Primary Purpose: Treatment
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: Quadruple

Arms and Interventions

Participant Group / Arm

Participant Group / Arm

A group or subgroup of participants in a clinical trial that receives a specific intervention/treatment, or no intervention, according to the trial's protocol.
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.
Experimental: Acupoint stimulation
needles are inserted into the skin of Baihui acupoint, and electrical acupoint stimulation is given
Other: electroacupuncture
electrical stimulation is given through needles inserted into the skin
Sham Comparator: Control
needles are shallowly inserted into the skin of Bihui acupoint, but no electrical acupoint stimulation is given
Other: sham needle
needles are inserted shallowly into the skin

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
Time Frame
arterial level of lactate at 30 minutes after recanalization
Time Frame: 30 minutes after recanalization
30 minutes after recanalization

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
arterial level of lactate immediately after recanalization
Time Frame: about 1 minute after recanalization
about 1 minute after recanalization
pH value at 30 minutes after recanalization
Time Frame: 30 minutes after recanalization
30 minutes after recanalization
Concentration of HCO3- at 30 minutes after recanalization
Time Frame: 30 minutes after recanalization
30 minutes after recanalization
Concentration of base excess at 30 minutes after recanalization
Time Frame: 30 minutes after recanalization
30 minutes after recanalization
partial pressure of oxygen at 30 minutes after recanalization
Time Frame: 30 minutes after recanalization
30 minutes after recanalization
partial pressure of carbon dioxide at 30 minutes after recanalization
Time Frame: 30 minutes after recanalization
30 minutes after recanalization
pH value immediately after recanalization
Time Frame: about 1 minute after recanalization
about 1 minute after recanalization
Concentration of HCO3- immediately after recanalization
Time Frame: about 1 minute after recanalization
about 1 minute after recanalization
Concentration of base excess immediately after recanalization
Time Frame: about 1 minute after recanalization
about 1 minute after recanalization
partial pressure of oxygen immediately after recanalization
Time Frame: about 1 minute after recanalization
about 1 minute after recanalization
partial pressure of carbon dioxide immediately after recanalization
Time Frame: about 1 minute after recanalization
about 1 minute after recanalization
Concentration of serum interleukin-6 at 30 minutes after recanalization
Time Frame: 30 minutes after recanalization
30 minutes after recanalization
Concentration of serum tumor necrosis factor α at 30 minutes after recanalization
Time Frame: 30 minutes after recanalization
30 minutes after recanalization
Concentration of serum brain-derived neurotrophic factor at 30 minutes after recanalization
Time Frame: 30 minutes after recanalization
30 minutes after recanalization
score of modified Rankin's scale at 24 hours after recanalization
Time Frame: 24 hours after recanalization
the minimum and maximum values of modified Rankin's scale is 0 and 5, and higher scores mean a worse outcome.
24 hours after recanalization
incidence of stroke during hospitalization
Time Frame: From end of surgery to discharge from hospital, at an average of 5 days
From end of surgery to discharge from hospital, at an average of 5 days
Incidence of death during hospitalization
Time Frame: From end of surgery to discharge from hospital, at an average of 5 days
From end of surgery to discharge from hospital, at an average of 5 days
length of hospitalization
Time Frame: From end of surgery to discharge from hospital, at an average of 5 days
From end of surgery to discharge from hospital, at an average of 5 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.
Air Force Military Medical University, China

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

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.
October 30, 2024

Primary Completion (Actual)

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.
December 25, 2024

Study Completion (Actual)

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, 2024

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).
July 4, 2024

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.
July 25, 2024

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.
July 26, 2024

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.
March 25, 2025

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.
January 13, 2025

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.
January 1, 2025

More Information

Terms related to this study

Keywords

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.
  • XJH-A-20240626

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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