Endovascular ProceduresASLANCT06521645
Effect of Acupoint Stimulation on Lactate During Cerebral Endovascular Intervention
A study testing electroacupuncture in people with Endovascular Procedures, run by Air Force Military Medical University, China at 1 site in China.
Trial summary
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… Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Endovascular Procedures
- What is being tested?
- electroacupuncture
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 28 participants
- Where
- 1 siteChina
- Study dates
- 30 Oct 2024to 30 Dec 2024
- Phase
- Interventional
- Are there results?
- None posted in the registry
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 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- age ≥18 years
- scheduled for cerebral endovascular intervention
Who cannot join
- 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)
Trial locations and contacts
1 site in 1 country.
China1 site
the First Affiliated Hospital of the Air Force Military Medical University
Xi'an, Shaanxi
About this study
Official title: 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.
- Conditions
- Endovascular Procedures
- Being tested
- electroacupuncture, sham needle
- Keywords
- acupoint stimulation, cerebral endovascular intervention, lactate
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
electroacupunctureOther
electrical stimulation is given through needles inserted into the skin
sham needleOther
needles are inserted shallowly into the skin
| Study group | Role | What they receive |
|---|---|---|
| Acupoint stimulation | Experimental | needles are inserted into the skin of Baihui acupoint, and electrical acupoint stimulation is given Receives: Other: electroacupuncture |
| Control | Sham comparator | needles are shallowly inserted into the skin of Bihui acupoint, but no electrical acupoint stimulation is given Receives: Other: sham needle |
What is being measured
The primary outcome is the main question the study is designed to answer.
arterial level of lactate at 30 minutes after recanalization
Measured: 30 minutes after recanalization
Secondary outcomes (18)
arterial level of lactate immediately after recanalization
Measured: about 1 minute after recanalization
pH value at 30 minutes after recanalization
Measured: 30 minutes after recanalization
Concentration of HCO3- at 30 minutes after recanalization
Measured: 30 minutes after recanalization
Concentration of base excess at 30 minutes after recanalization
Measured: 30 minutes after recanalization
partial pressure of oxygen at 30 minutes after recanalization
Measured: 30 minutes after recanalization
partial pressure of carbon dioxide at 30 minutes after recanalization
Measured: 30 minutes after recanalization
pH value immediately after recanalization
Measured: about 1 minute after recanalization
Concentration of HCO3- immediately after recanalization
Measured: about 1 minute after recanalization
Concentration of base excess immediately after recanalization
Measured: about 1 minute after recanalization
partial pressure of oxygen immediately after recanalization
Measured: about 1 minute after recanalization
partial pressure of carbon dioxide immediately after recanalization
Measured: about 1 minute after recanalization
Concentration of serum interleukin-6 at 30 minutes after recanalization
Measured: 30 minutes after recanalization
Concentration of serum tumor necrosis factor α at 30 minutes after recanalization
Measured: 30 minutes after recanalization
Concentration of serum brain-derived neurotrophic factor at 30 minutes after recanalization
Measured: 30 minutes after recanalization
score of modified Rankin's scale at 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.
Measured: 24 hours after recanalization
incidence of stroke during hospitalization
Measured: From end of surgery to discharge from hospital, at an average of 5 days
Incidence of death during hospitalization
Measured: From end of surgery to discharge from hospital, at an average of 5 days
length of hospitalization
Measured: From end of surgery to discharge from hospital, at an average of 5 days
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted26 Jul 2024
- Study start30 Oct 2024
- Primary completion25 Dec 2024
- Study completion30 Dec 2024
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (2)Papers the sponsor has linked to this study.
- Other trials for Endovascular ProceduresStudies 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
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Quadruple blind
- Who is masked
- Participant, Care provider, Investigator, Outcomes assessor
- Enrolment
- 28 participants (actual)
Sponsor and investigators
- Lead sponsor
- Air Force Military Medical University, China
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Zhihong LU, Air Force Military Medical University, China
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06521645
- Sponsor's protocol ID
- XJH-A-20240626
- Acronym
- ASLA
- Status last verified
- Jan 2025
- First submitted
- 4 Jul 2024
- Last updated
- 14 Jan 2025
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Publications
Garzelli L, Nuzzo A, Hamon A, Ben Abdallah I, Gregory J, Raynaud L, Paulatto L, Dioguardi Burgio M, Castier Y, Panis Y, Vilgrain V, Corcos O, Ronot M. Reperfusion injury on computed tomography following endovascular revascularization of acute mesenteric ischemia: prevalence, risk factors, and patient outcome. Insights Imaging. 2022 Dec 13;13(1):194. doi: 10.1186/s13244-022-01339-9.
PubMed 36512135Onalan A, Gurkas E, Akpinar CK, Dogan H, Acar T, Acar B, Aykac O, Uysal Kocabas Z, Balgetir F, Ozdemir AO. Arterial blood gas analysis predicts futile recanalization in mechanical thrombectomy-treated acute ischemic stroke patients: a multicenter study. Eur Rev Med Pharmacol Sci. 2024 Feb;28(4):1594-1604. doi: 10.26355/eurrev_202402_35488.
PubMed 38436197
Study at a glance
From the registry record, last updated by the sponsor on 14 Jan 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- The Effect of Acupoint Stimulation on Level of Lactate in Patients Undergoing Cerebral Endovascular Intervention
- ClinicalTrials.gov ID
- NCT06521645
- Acronym / sponsor ID
- ASLA / XJH-A-20240626
- Conditions
- Endovascular Procedures
- Keywords
- acupoint stimulation, cerebral endovascular intervention, lactate
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 28 participants (actual)
- Lead sponsor
- Air Force Military Medical University, ChinaUniversity, hospital or other
- Study start
- 30 Oct 2024 (actual)
- Primary completion
- 25 Dec 2024 (actual)
- Study completion
- 30 Dec 2024 (actual)
- First posted
- 26 Jul 2024 (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.
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 design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Quadruple blind (participant, care provider, investigator, outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Acupoint stimulation | Experimental | Other: electroacupunctureneedles are inserted into the skin of Baihui acupoint, and electrical acupoint stimulation is given |
| Control | Sham comparator | Other: sham needleneedles are shallowly inserted into the skin of Bihui acupoint, but no electrical acupoint stimulation is given |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (2 listed)
- age ≥18 years
- scheduled for cerebral endovascular intervention
Key exclusion criteria (6 listed)
- 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
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 |
|---|---|---|
| electroacupunctureelectrical stimulation is given through needles inserted into the skin | Other | Acupoint stimulation |
| sham needleneedles are inserted shallowly into the skin | Other | Control |
Primary outcome
arterial level of lactate at 30 minutes after recanalization
Time frame: 30 minutes after recanalization
18 secondary outcomes
arterial level of lactate immediately after recanalization
Time frame: about 1 minute after recanalization
pH value at 30 minutes after recanalization
Time frame: 30 minutes after recanalization
Concentration of HCO3- at 30 minutes after recanalization
Time frame: 30 minutes after recanalization
Concentration of base excess at 30 minutes after recanalization
Time frame: 30 minutes after recanalization
partial pressure of oxygen at 30 minutes after recanalization
Time frame: 30 minutes after recanalization
partial pressure of carbon dioxide at 30 minutes after recanalization
Time frame: 30 minutes after recanalization
pH value immediately after recanalization
Time frame: about 1 minute after recanalization
Concentration of HCO3- immediately after recanalization
Time frame: about 1 minute after recanalization
Concentration of base excess immediately after recanalization
Time frame: about 1 minute after recanalization
partial pressure of oxygen immediately after recanalization
Time frame: about 1 minute after recanalization
partial pressure of carbon dioxide immediately after recanalization
Time frame: about 1 minute after recanalization
Concentration of serum interleukin-6 at 30 minutes after recanalization
Time frame: 30 minutes after recanalization
Concentration of serum tumor necrosis factor α at 30 minutes after recanalization
Time frame: 30 minutes after recanalization
Concentration of serum brain-derived neurotrophic factor at 30 minutes after recanalization
Time frame: 30 minutes after recanalization
score of modified Rankin's scale at 24 hours after recanalization
Time frame: 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
Incidence of death during hospitalization
Time frame: 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
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 14 Jan 2025.
- Background: PubMed 36512135Garzelli L, Nuzzo A, Hamon A, Ben Abdallah I, Gregory J, Raynaud L, Paulatto L, Dioguardi Burgio M, Castier Y, Panis Y, Vilgrain V, Corcos O, Ronot M. Reperfusion injury on computed tomography following endovascular revascularization of acute mesenteric ischemia: prevalence, risk factors, and patient outcome. Insights Imaging. 2022 Dec 13;13(1):194. doi: 10.1186/s13244-022-01339-9.
- Results publication: PubMed 38436197Onalan A, Gurkas E, Akpinar CK, Dogan H, Acar T, Acar B, Aykac O, Uysal Kocabas Z, Balgetir F, Ozdemir AO. Arterial blood gas analysis predicts futile recanalization in mechanical thrombectomy-treated acute ischemic stroke patients: a multicenter study. Eur Rev Med Pharmacol Sci. 2024 Feb;28(4):1594-1604. doi: 10.26355/eurrev_202402_35488.
- Individual participant dataSharing planned: No
Related trials for Endovascular Procedures
Not yet recruitingPhase 3
TicAgreLor Versus Placebo to Prevent Cerebral ISCHemia in anEuRysmal Low Grade SAH A Double Blinded Randomised Controlled Study
Subarachnoid Hemorrhage, Aneurysmal, Brain Ischemia
RecruitingObservational study
Treatment Outcomes and Predictors After Endovascular Intervention for Portal Hypertension-Related Gastrointestinal Bleeding in Cirrhosis
Cirrhosis, Portal Hypertension Related to Cirrhosis
RecruitingPhase 4
Inclisiran Versus Placebo for the Prevention of Major Adverse Cardiovascular and Limb Events in Patients Undergoing Percutaneous Coronary Intervention or Peripheral Endovascular Intervention
Percutaneous Coronary Intervention, Peripheral Endovascular Intervention
Active, not recruiting
Preventing Kidney Injury Using Carbon Dioxide as Contrast Medium in Patients With Peripheral Arterial Disease (PAD) and Chronic Kidney Disease (CKD) Having Arterial Intervention
Peripheral Arterial Disease, Chronic Kidney Diseases
Recruiting
MENA Regional Endovascular Intervention for Venous Cerebral Venous Sinus Thrombosis
Cerebral Venous Sinus Thrombosis
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. This study is not recruiting at the moment.
The record lists no contact. Use the official record to reach the sponsor.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing electroacupuncture in people with Endovascular Procedures, run by Air Force Military Medical University, China 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 6 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: finished, as of the sponsor's last update on 14 Jan 2025. 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. Some participants in this study may receive a placebo. 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?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
arterial level of lactate at 30 minutes after recanalization (time frame: 30 minutes after recanalization). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT06521645, which also lists 2 linked publications.
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 14 Jan 2025.