StrokeNCT01020266
Neuroprotective Study of Electroacupuncture Pretreatment in Patients Undergoing Cardiac Surgery
A study testing non electroacupuncture stimulation and Electroacupuncture pretreatment in people with Stroke and Brain Injuries, run by Xijing Hospital at 1 site in China.
Trial summary
The purpose of this study is to evaluate the neuroprotective effect of electroacupuncture pretreatment in patients undergoing cardiac surgery as an preventive sequela in a randomized and controlled clinical trial. In addition, to investigate the role of inflammatory responses in the precess of the protection. Read more about this study
- Who is it for?
- Ages 40 to 65 years
- Conditions the study is for
- Stroke, Brain Injuries
- What is being tested?
- non electroacupuncture stimulation and Electroacupuncture pretreatment
- Type of treatment
- Surgery or procedure
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 300 participants
- Where
- 1 siteChina
- Study dates
- Dec 2009to Jun 2013
- 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 40 to 65 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- patients who have the indication for aortic or mitral valve replacement
- patients would like to accept the follow-up and sign the informed consent
- patients with heart function of NYHA I-III degree.
Who cannot join
- pregnant or nursing women
- comorbid with coronary artery disease
- patients with heart function of NYHA IV degree
- renal dysfunction with serum creatinine level>or=2mg/dl(177umol/L)
- anticipated life span < 12 months
- enrollment in other clinical trials at the same time not reaching the primary endpoint and probably interference the present trial.
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Clinical Trial of Cerebral Protective Effects of Repeated Electroacupuncture Pretreatment in Heart Valve Replacement Surgery
The purpose of this study is to evaluate the neuroprotective effect of electroacupuncture pretreatment in patients undergoing cardiac surgery as an preventive sequela in a randomized and controlled clinical trial. In addition, to investigate the role of inflammatory responses in the precess of the protection.
Read the detailed description
Heart valve replacement surgery has been proved to be an effective method in treating both regenerative and rheumatic valve disease. Current studies showed that cardiopulmonary bypass (CPB) and operation related cerebral injury is associated with worse patient morbidity and mortality after elective valve replacement surgery. Recently, Electroacupuncture (EA) pretreatment was proved to produced cerebral protective effects by mimicking ischemic preconditioning in animal models. However, the evidence that EA pretreatment can improve the clinical outcomes such as mortality and morbidity, is still lacking. The investigators perform a randomized controlled study to evaluate that EA pretreatment can improve the outcomes of cardiac surgery.
Purpose:
The purpose of this study is to examine if EA pretreatment can decrease the mortality and postoperative cerebrovascular complications in patients undergoing cardiac surgery. The effect will be assessed by mortality, scores of neurological defect, post operative cognitive dysfunction and stroke.
Methods:
Study patients will be randomized to cardiac surgery with EA pretreatment or conventional cardiac surgery in the Department of cardiovascular surgery, Xijing Hospital. EA pretreatment is performed at Baihui acupoint 30 min per day 5 consecutive days before the heart valve replacement surgery．Primary study outcome is cerebrovascular complications within 6 postoperative months. Secondary outcomes include the S-100B and NSE blood level measured during the first 72 hours of surgery follow-up, the several cytokines, including TNF-a, IL-8, IL-6, IL-10 and HMGB-1 blood level measured during the first 7 days of surgery follow-up, all cardiovascular haemodynamic parameters as measured by a pulmonary artery catheter, the length of intensive care unit (ICU) stay and length of postoperative hospital stay.
- Conditions
- Stroke, Brain Injuries
- Being tested
- non electroacupuncture stimulation, Electroacupuncture pretreatment
- Keywords
- brain protection, cardiac surgery, heart valve replacement, electroacupuncture, pretreatment, preconditioning, Thoracic Surgery
- Medical subject headings
- Stroke, Brain Injuries
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
non electroacupuncture stimulationProcedure or surgery
The same procedure as electroacupuncture except stimulation
Electroacupuncture pretreatmentProcedure or surgery
Also called Acupuncture, preconditioning, electric stimulation
According to the theory of traditional Chinese medicine, Baihui(GV20) acupoint was chosen and the acupuncture points were identified according to traditional anatomical localization. Once insertion was made at the acupuncture point, the needle was stimulated electrically with the intensity of 0.8-1.9 mA and frequency of 5/30 Hz for 30 min per day using an Electronic Acupuncture Treatment Instrument for 5 consecutive days before the heart valve replacement surgery．
| Study group | Role | What they receive |
|---|---|---|
| Electroacupuncture | Active comparator | Not described Receives: Procedure: Electroacupuncture pretreatment |
| Control | Sham comparator | Not described Receives: Procedure: non electroacupuncture stimulation |
What is being measured
The primary outcome is the main question the study is designed to answer.
Cerebrovascular complications and Score of neurological defect
Measured: before treatment, after the first treatment, 7, 28days after treatment and follow up at 6 months after treatment
Secondary outcomes (1)
The S-100B and NSE blood level
Measured: before treatment, after the last treatment, before surgery, and the first 72 hours of surgery follow-up
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted25 Nov 2009 (estimated)
- Study startDec 2009
- Primary completionSep 2010
- Study completionJun 2013
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for StrokeStudies of the same condition, open and under way.
- More trials run by Xijing HospitalThe sponsor's other registered studies.
- 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
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind
- Who is masked
- Participant, Outcomes assessor
- Enrolment
- 300 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Xijing Hospital
- Sponsor type
- University, hospital or other
- Collaborators
- Air Force Military Medical University, China
- Responsible party
- Sponsor
- Investigators
- Aideng Weng, Ph.D., Study director, Xijing Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01020266
- Sponsor's protocol ID
- XJMZK015
- Status last verified
- Nov 2009
- First submitted
- 22 Nov 2009
- Last updated
- 25 Jun 2015
- Results posted
- No
- Data monitoring committee
- Yes
Study at a glance
From the registry record, last updated by the sponsor on 25 Jun 2015. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Clinical Trial of Cerebral Protective Effects of Repeated Electroacupuncture Pretreatment in Heart Valve Replacement Surgery
- ClinicalTrials.gov ID
- NCT01020266
- Acronym / sponsor ID
- XJMZK015
- Conditions
- Stroke, Brain Injuries
- Keywords
- brain protection, cardiac surgery, heart valve replacement, electroacupuncture, pretreatment, preconditioning, Thoracic Surgery
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 300 participants (estimated)
- Lead sponsor
- Xijing HospitalUniversity, hospital or other
- Collaborators
- Air Force Military Medical University, China
- Study start
- Dec 2009
- Primary completion
- Sep 2010 (actual)
- Study completion
- Jun 2013 (actual)
- First posted
- 25 Nov 2009 (estimated)
- 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.
The purpose of this study is to evaluate the neuroprotective effect of electroacupuncture pretreatment in patients undergoing cardiac surgery as an preventive sequela in a randomized and controlled clinical trial. In addition, to investigate the role of inflammatory responses in the precess of the protection.
Detailed description
Heart valve replacement surgery has been proved to be an effective method in treating both regenerative and rheumatic valve disease. Current studies showed that cardiopulmonary bypass (CPB) and operation related cerebral injury is associated with worse patient morbidity and mortality after elective valve replacement surgery. Recently, Electroacupuncture (EA) pretreatment was proved to produced cerebral protective effects by mimicking ischemic preconditioning in animal models. However, the evidence that EA pretreatment can improve the clinical outcomes such as mortality and morbidity, is still lacking. The investigators perform a randomized controlled study to evaluate that EA pretreatment can improve the outcomes of cardiac surgery.
Purpose:
The purpose of this study is to examine if EA pretreatment can decrease the mortality and postoperative cerebrovascular complications in patients undergoing cardiac surgery. The effect will be assessed by mortality, scores of neurological defect, post operative cognitive dysfunction and stroke.
Methods:
Study patients will be randomized to cardiac surgery with EA pretreatment or conventional cardiac surgery in the Department of cardiovascular surgery, Xijing Hospital. EA pretreatment is performed at Baihui acupoint 30 min per day 5 consecutive days before the heart valve replacement surgery．Primary study outcome is cerebrovascular complications within 6 postoperative months. Secondary outcomes include the S-100B and NSE blood level measured during the first 72 hours of surgery follow-up, the several cytokines, including TNF-a, IL-8, IL-6, IL-10 and HMGB-1 blood level measured during the first 7 days of surgery follow-up, all cardiovascular haemodynamic parameters as measured by a pulmonary artery catheter, the length of intensive care unit (ICU) stay and length of postoperative hospital stay.
Study design
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind (participant, outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Electroacupuncture | Active comparator | Procedure: Electroacupuncture pretreatment |
| Control | Sham comparator | Procedure: non electroacupuncture stimulation |
Who may qualify
- Ages
- 40 to 65 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (3 listed)
- patients who have the indication for aortic or mitral valve replacement
- patients would like to accept the follow-up and sign the informed consent
- patients with heart function of NYHA I-III degree.
Key exclusion criteria (6 listed)
- pregnant or nursing women
- comorbid with coronary artery disease
- patients with heart function of NYHA IV degree
- renal dysfunction with serum creatinine level>or=2mg/dl(177umol/L)
- anticipated life span < 12 months
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 |
|---|---|---|
| non electroacupuncture stimulationThe same procedure as electroacupuncture except stimulation | Procedure or surgery | Control |
| Electroacupuncture pretreatmentAlso: Acupuncture, preconditioning, electric stimulationAccording to the theory of traditional Chinese medicine, Baihui(GV20) acupoint was chosen and the acupuncture points were identified according to traditional anatomical localization. Once insertion was made at the acupuncture point, the needle was stimulated electrically with the intensity of 0.8-1.9 mA and frequency of 5/30 Hz for 30 min per day using an Electronic Acupuncture Treatment Instrument for 5 consecutive days before the heart valve replacement surgery． | Procedure or surgery | Electroacupuncture |
Primary outcome
Cerebrovascular complications and Score of neurological defect
Time frame: before treatment, after the first treatment, 7, 28days after treatment and follow up at 6 months after treatment
1 secondary outcome
The S-100B and NSE blood level
Time frame: before treatment, after the last treatment, before surgery, and the first 72 hours of surgery follow-up
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 25 Jun 2015.
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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. This study is not recruiting at the moment.
Aideng Weng, Ph.D. study director
Xijing Hospital
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing non electroacupuncture stimulation and Electroacupuncture pretreatment in people with Stroke and Brain Injuries, run by Xijing Hospital 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 3 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 25 Jun 2015. 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?
Cerebrovascular complications and Score of neurological defect (time frame: before treatment, after the first treatment, 7, 28days after treatment and follow up at 6 months after treatment). 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 25 Jun 2015.