Coronary Heart DiseaseNCT01507805
Electroacupuncture Preconditioning on Geriatric Noncardiac Surgery
A study testing EA preconditioning in people with Coronary Heart Disease, run by Xijing Hospital at 1 site in China.
Trial summary
The purpose of this study is to observe whether the electroacupuncture (EA) preconditioning for five days before operation can improve the outcomes of patients with coronary heart disease undergoing geriatric non-cardiac surgery. Read more about this study
- Who is it for?
- Ages 65 years and older
- Conditions the study is for
- Coronary Heart Disease
- What is being tested?
- EA preconditioning
- Type of treatment
- Medical device
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 300 participants
- Where
- 1 siteChina
- Study dates
- Feb 2011to Jan 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 65 years and older
- All sexes
- No healthy volunteers
- Older adult
Who may be able to join
- elective abdominal surgery with coronary heart disease
Who cannot join
- serious bradycardiac arrythmia
Trial locations and contacts
1 site in 1 country.
China1 site, 1 recruiting
- Recruiting
Xijing hospital
Xi'an, Shannxi, 710032
Zhaoyang Xiao, Ph.D., M.D., 86 15009250798, xiaozhaoy2006@hotmail.com
Shaoyang Chen, M.D.
About this study
Official title: Effects of Electroacupuncture Preconditioning on Outcomes of the Geriatric Patients With Coronary Heart Disease Undergoing Non-cardiac Surgery
The purpose of this study is to observe whether the electroacupuncture (EA) preconditioning for five days before operation can improve the outcomes of patients with coronary heart disease undergoing geriatric non-cardiac surgery.
Read the detailed description
BACKGROUND:
With the development of surgical techniques, more and more people with coronary heart disease underwent non-cardiac surgery, which include abdominal, urologic, orthopedic surgeries. Due to the vulnerable heart function, geriatric patients suffer high incidence of cardiovascular events during the peri-operative period. Some studies found that EA preconditioning have a protective effect for the patients underwent Cardiac surgery. But non one addresses the effects of EA preconditioning on the outcomes of the patients with coronary heart disease who undergo non-cardiac surgery.
DESIGNING:
The patients with coronary heart disease who will receive abdominal surgery will be randomly assigned into EA preconditioning group and control group. The patients in EA preconditioning group was treated at bilateral Neiguan (PC 6)，Lieque (LU 7) and Yunmen (LU 2) with electrical stimulation (5-30 Hz，2．34-6．24 mA，30 min) for 5 consecutive days before surgery．Before operation and before surgery, after surgery, 24h, 72h post surgery, all patients will be subjected to test the serum level of c-reactive protein and Troponin I. The EEG and heart ultrasonic exam will be used to evaluate the condition and function of heart before and after surgery.
- Conditions
- Coronary Heart Disease
- Being tested
- EA preconditioning, sham EA preconditioning
- Keywords
- Electroacupuncture, preconditioning, Non-cardiac surgery, Coronary heart disease
- Medical subject headings
- Coronary Disease
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
EA preconditioningDevice
Also called Huantuo sdz-Ⅱ,Suzhou Medical Limit
EA preconditioning group was treated at bilateral Neiguan(PC 6)，Lieque(LU 7)and Yunmen(LU 2)with electrical stimulation(5-30 Hz，2．34-6．24 mA，30 min)for 5 consecutive days before surgery
sham EA preconditioningDevice
Patients in Sham EA preconditioning group was treated at bilateral Neiguan(PC 6)，Lieque(LU 7)and Yunmen(LU 2)without electrical stimulation(5-30 Hz，2．34-6．24 mA，30 min)for 5 consecutive days before surgery
| Study group | Role | What they receive |
|---|---|---|
| EA preconditioning | Experimental | electroacupuncture five days pre-operation Receives: Device: EA preconditioning |
| Sham EA preconditioning | Sham comparator | Patients treated with sham EA preconditioning Intervention Receives: Device: sham EA preconditioning |
What is being measured
The primary outcome is the main question the study is designed to answer.
The change of myocardial ischemic injury markers,including serum level of c-reactive protein and Troponin I
to observe the change of the level of multiple myocardial ischemic injury markers at the different time points.
Measured: 10 minutes before EA, 10 minutes pre-operation,the day of post-operation, 24hours post-operation, 72 hours post-operation
Secondary outcomes (2)
The change of ST segment of EEG at different time points
Measured: 10 minutes before EA, 10 minutes pre-operation,the day of post-operation, 24hours post-operation, 72 hours post-operation
Cardiac ultrasonic scan
be aware of cardiac function
Measured: five days pre-operation , five days post-operation
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted11 Jan 2012 (estimated)
- Study startFeb 2011
- Primary completionJun 2012 (estimated)
- Study completionJan 2013 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Coronary Heart DiseaseStudies 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
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 300 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Xijing Hospital
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Shaoyang Chen, M.D., Principal investigator, Xijing Hospital, the Fourth Military Medical University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01507805
- Sponsor's protocol ID
- csyxijing
- Status last verified
- Feb 2011
- First submitted
- 13 Dec 2011
- Last updated
- 11 Jan 2012
- Results posted
- No
- Data monitoring committee
- Yes
Study at a glance
From the registry record, last updated by the sponsor on 11 Jan 2012. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Effects of Electroacupuncture Preconditioning on Outcomes of the Geriatric Patients With Coronary Heart Disease Undergoing Non-cardiac Surgery
- ClinicalTrials.gov ID
- NCT01507805
- Acronym / sponsor ID
- csyxijing
- Conditions
- Coronary Heart Disease
- Keywords
- Electroacupuncture, preconditioning, Non-cardiac surgery, Coronary heart disease
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 300 participants (estimated)
- Lead sponsor
- Xijing HospitalUniversity, hospital or other
- Study start
- Feb 2011
- Primary completion
- Jun 2012 (estimated)
- Study completion
- Jan 2013 (estimated)
- First posted
- 11 Jan 2012 (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 observe whether the electroacupuncture (EA) preconditioning for five days before operation can improve the outcomes of patients with coronary heart disease undergoing geriatric non-cardiac surgery.
Detailed description
BACKGROUND:
With the development of surgical techniques, more and more people with coronary heart disease underwent non-cardiac surgery, which include abdominal, urologic, orthopedic surgeries. Due to the vulnerable heart function, geriatric patients suffer high incidence of cardiovascular events during the peri-operative period. Some studies found that EA preconditioning have a protective effect for the patients underwent Cardiac surgery. But non one addresses the effects of EA preconditioning on the outcomes of the patients with coronary heart disease who undergo non-cardiac surgery.
DESIGNING:
The patients with coronary heart disease who will receive abdominal surgery will be randomly assigned into EA preconditioning group and control group. The patients in EA preconditioning group was treated at bilateral Neiguan (PC 6)，Lieque (LU 7) and Yunmen (LU 2) with electrical stimulation (5-30 Hz，2．34-6．24 mA，30 min) for 5 consecutive days before surgery．Before operation and before surgery, after surgery, 24h, 72h post surgery, all patients will be subjected to test the serum level of c-reactive protein and Troponin I. The EEG and heart ultrasonic exam will be used to evaluate the condition and function of heart before and after surgery.
Study design
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| EA preconditioning | Experimental | Device: EA preconditioningelectroacupuncture five days pre-operation |
| Sham EA preconditioning | Sham comparator | Device: sham EA preconditioningPatients treated with sham EA preconditioning Intervention |
Who may qualify
- Ages
- 65 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Older adult
Key inclusion criteria (1 listed)
- elective abdominal surgery with coronary heart disease
Key exclusion criteria (1 listed)
- serious bradycardiac arrythmia
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 |
|---|---|---|
| EA preconditioningAlso: Huantuo sdz-Ⅱ,Suzhou Medical LimitEA preconditioning group was treated at bilateral Neiguan(PC 6)，Lieque(LU 7)and Yunmen(LU 2)with electrical stimulation(5-30 Hz，2．34-6．24 mA，30 min)for 5 consecutive days before surgery | Device | EA preconditioning |
| sham EA preconditioningPatients in Sham EA preconditioning group was treated at bilateral Neiguan(PC 6)，Lieque(LU 7)and Yunmen(LU 2)without electrical stimulation(5-30 Hz，2．34-6．24 mA，30 min)for 5 consecutive days before surgery | Device | Sham EA preconditioning |
Primary outcome
The change of myocardial ischemic injury markers,including serum level of c-reactive protein and Troponin I
Time frame: 10 minutes before EA, 10 minutes pre-operation,the day of post-operation, 24hours post-operation, 72 hours post-operation
to observe the change of the level of multiple myocardial ischemic injury markers at the different time points.
2 secondary outcomes
The change of ST segment of EEG at different time points
Time frame: 10 minutes before EA, 10 minutes pre-operation,the day of post-operation, 24hours post-operation, 72 hours post-operation
Cardiac ultrasonic scan
Time frame: five days pre-operation , five days post-operation
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 11 Jan 2012.
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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.
Shaoyang Chen, M.D. principal investigator
Xijing Hospital, the Fourth Military Medical University
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing EA preconditioning in people with Coronary Heart Disease, 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 1 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: status not confirmed, as of the sponsor's last update on 11 Jan 2012. 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?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Each site lists its own contact: choose the nearest one under Trial locations. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
The change of myocardial ischemic injury markers,including serum level of c-reactive protein and Troponin I (time frame: 10 minutes before EA, 10 minutes pre-operation,the day of post-operation, 24hours post-operation, 72 hours post-operation). 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 11 Jan 2012.