Rheumatic Valve DiseaseNCT00732459
Clinical Trial of Electro-Acupuncture Preconditioning in Patients Underwent Heart Valve Replacement Surgery
An observational study of Rheumatic Valve Disease, run by Xijing Hospital at 1 site in China.
Trial summary
The purpose of this study is to investigate the protective effect of electro-acupuncture preconditioning in patients underwent cardiac surgery. Read more about this study
- Who is it for?
- Ages 40 to 65 years
- Conditions the study is for
- Rheumatic Valve Disease
- What is being tested?
- Electro-acupuncture preconditioning
- Type of treatment
- Medical device
- How many people
- 60 participants
- Where
- 1 siteChina
- Study dates
- Jan 2007to Dec 2008
- Phase
- Observational
- 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
Study population: This study enrolls a group of 40-65years patients who have heart valve disease who need valve replacement.
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.
China1 site
Department of Anesthesiology of Xijing Hospital, Fourth Military Medical University
Xi'an, Shaanxi, 710032
About this study
Official title: Clinical Trial of The Myocardial Protective Effects of Repeated Electroacupuncture Preconditioning in Heart Valve Replacement Surgery
The purpose of this study is to investigate the protective effect of electro-acupuncture preconditioning in patients underwent cardiac surgery.
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 myocardial injury, as indicated by the release of perioperative cardiac enzymes, is associated with worse patient morbidity and mortality after elective valve replacement surgery. Although the actual mechanism is still unclear, it has been shown that ischemic preconditioning is one potential strategy for reduction of myocardial injury in open heart surgery. Recently, Electro- acupuncture (EA) was proved to produced cerebral protective and antiarrhythmic effects by mimicking ischemic preconditioning. This study aims to assess whether electroacupuncture preconditioning is also effective in reducing myocardial injury in adults with acquired heart valve disease undergoing elective valve replacement surgery.
- Conditions
- Rheumatic Valve Disease
- Being tested
- Electro-acupuncture preconditioning
- Keywords
- myocardial protection, cardiac surgery, heart valve replacement
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Electro-acupuncture preconditioningDevice
Also called Huatuo Brand, Type SDZ-II
electro-acupuncture
| Study group | Role | What they receive |
|---|---|---|
| 1 | electro-acupuncture preconditioning group Receives: Device: Electro-acupuncture preconditioning | |
| 2 | control group |
What is being measured
The primary outcome is the main question the study is designed to answer.
late loss
Measured: 12 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted12 Aug 2008 (estimated)
- Study startJan 2007
- Primary completionJul 2008
- Study completionDec 2008 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Rheumatic Valve DiseaseStudies 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
- Observational
- Observational model
- Cohort
- Time perspective
- Prospective
- Enrolment
- 60 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Xijing Hospital
- Sponsor type
- University, hospital or other
- Collaborators
- Air Force Military Medical University, China
- Investigators
- Lize Xiong, M.D., Study chair, Director of Department of Anasthesiology of Xijing Hospital, Fourth Military Medical University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00732459
- Sponsor's protocol ID
- XJ-20080808
- Status last verified
- Aug 2008
- First submitted
- 9 Aug 2008
- Last updated
- 18 Aug 2008
- Results posted
- No
- Data monitoring committee
- Yes
Publications
Yang L, Yang J, Wang Q, Chen M, Lu Z, Chen S, Xiong L. Cardioprotective effects of electroacupuncture pretreatment on patients undergoing heart valve replacement surgery: a randomized controlled trial. Ann Thorac Surg. 2010 Mar;89(3):781-6. doi: 10.1016/j.athoracsur.2009.12.003.
PubMed 20172127
Study at a glance
From the registry record, last updated by the sponsor on 18 Aug 2008. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Clinical Trial of The Myocardial Protective Effects of Repeated Electroacupuncture Preconditioning in Heart Valve Replacement Surgery
- ClinicalTrials.gov ID
- NCT00732459
- Acronym / sponsor ID
- XJ-20080808
- Conditions
- Rheumatic Valve Disease
- Keywords
- myocardial protection, cardiac surgery, heart valve replacement
- Study type
- Observational
- Recruitment status
- Unknown status
- Enrolment
- 60 participants (estimated)
- Lead sponsor
- Xijing HospitalUniversity, hospital or other
- Collaborators
- Air Force Military Medical University, China
- Study start
- Jan 2007
- Primary completion
- Jul 2008 (actual)
- Study completion
- Dec 2008 (estimated)
- First posted
- 12 Aug 2008 (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 investigate the protective effect of electro-acupuncture preconditioning in patients underwent cardiac surgery.
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 myocardial injury, as indicated by the release of perioperative cardiac enzymes, is associated with worse patient morbidity and mortality after elective valve replacement surgery. Although the actual mechanism is still unclear, it has been shown that ischemic preconditioning is one potential strategy for reduction of myocardial injury in open heart surgery. Recently, Electro- acupuncture (EA) was proved to produced cerebral protective and antiarrhythmic effects by mimicking ischemic preconditioning. This study aims to assess whether electroacupuncture preconditioning is also effective in reducing myocardial injury in adults with acquired heart valve disease undergoing elective valve replacement surgery.
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| 1 | – | Device: Electro-acupuncture preconditioningelectro-acupuncture preconditioning group |
| 2 | – | –control group |
Who may qualify
- Ages
- 40 to 65 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- This study enrolls a group of 40-65years patients who have heart valve disease who need valve replacement.
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 |
|---|---|---|
| Electro-acupuncture preconditioningAlso: Huatuo Brand, Type SDZ-IIelectro-acupuncture | Device | 1 |
Primary outcome
late loss
Time frame: 12 months
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 18 Aug 2008.
- Derived from this study: PubMed 20172127Yang L, Yang J, Wang Q, Chen M, Lu Z, Chen S, Xiong L. Cardioprotective effects of electroacupuncture pretreatment on patients undergoing heart valve replacement surgery: a randomized controlled trial. Ann Thorac Surg. 2010 Mar;89(3):781-6. doi: 10.1016/j.athoracsur.2009.12.003.
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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.
Lize Xiong, M.D. study chair
Director of Department of Anasthesiology of Xijing Hospital, 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?
An observational study of Rheumatic Valve 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 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: status not confirmed, as of the sponsor's last update on 18 Aug 2008. 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. 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?
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?
late loss (time frame: 12 months). 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 NCT00732459, which also lists 1 linked publication.
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 18 Aug 2008.