Myocardial InjuryNCT01020942
Cardioprotective Effects of Electroacupuncture Pretreatment Against Coronary Stenting
A study testing Electroacupuncture stimulation in people with Myocardial Injury, run by Xijing Hospital at 1 site in China.
Trial summary
Myocyte necrosis as a result of elective percutaneous coronary intervention (PCI) occurs in approximately one third of cases and is associated with subsequent cardiovascular events. This study assesses the ability of electroacupuncture (EA) pretreatment to attenuate cardiac troponin I (cTnI) release after elective PCI. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Myocardial Injury
- What is being tested?
- Electroacupuncture stimulation
- Type of treatment
- Surgery or procedure
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 500 participants
- Where
- 1 siteChina
- Study dates
- Jan 2010to Jun 2012
- 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
- All patients > 18 of age who are undergoing elective PCI and are able to give informed consent are eligible for study.
Who cannot join
- Emergency PCI,
- Elevation of cTnI before PCI taken at the preadmission clinic,
- Women of child-bearing age,
- Nicorandil or glibenclamide use (preconditioning-mimetic and preconditioning blocking medication, respectively), and
- Severe comorbidity (estimated life expectancy < 6 months).
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Cardioprotective of Electroacupuncture Pretreatment in Patients Underwent Coronary Stenting: A Prospective, Multicenter, Randomized Control Trial
Myocyte necrosis as a result of elective percutaneous coronary intervention (PCI) occurs in approximately one third of cases and is associated with subsequent cardiovascular events. This study assesses the ability of electroacupuncture (EA) pretreatment to attenuate cardiac troponin I (cTnI) release after elective PCI.
Read the detailed description
Elective percutaneous coronary intervention (PCI) is associated with troponin release in approximately one third of cases.Troponin release is a sensitive and specific marker of myocyte necrosis and infarction resulting from a form of ischemia/reperfusion injury, downstream embolization of atheromatous material, and coronary side-branch occlusion. A number of studies have demonstrated that procedure-related troponin release is associated with subsequent cardiovascular events.
Transient sublethal episodes of ischemia before a prolonged ischemia/reperfusion injury, known as ischemic preconditioning (IPC), have been shown to reduce the extent of myocardial infarction (MI).Electroacupuncture (EA) stimulus, as a pretreatment method, limits MI size in animal models. However, there are limited outcome to demonstrate protection from EA pretreatment during PCI. The present study investigated the ability of EA pretreatment to attenuate cardiac troponin I (cTnI) release after elective PCI in a single-center, randomized controlled trial.
- Conditions
- Myocardial Injury
- Being tested
- Electroacupuncture stimulation, No intervention
- Keywords
- ischemia, myocardial infarction, prognosis, pretreatment, electroacupuncture, stents, troponin, percutaneous coronary intervention
- Medical subject headings
- Ischemia, Myocardial Infarction
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Electroacupuncture stimulationProcedure or surgery
Also called Preconditioning
According to the theory of traditional Chinese medicine, bilateral Neiguan (PC 6) acupoints were chosen and identified according to traditional anatomical localizations. Once insertion of original needles was made at the acupoints, the needle was stimulated electrically with the intensity of 2-6 mA and frequency of 2/30 Hz using the Electronic Acupuncture Treatment Instrument until the patient felt the so-called 'Teh Chi' sensation of heaviness, numbness and swelling. The pretreatment was individualized based on patients sex, age, weight and felt and given 1 time per day for 5 consecutive days before the heart valve replacement surgery．
No interventionProcedure or surgery
Also called Sham pretreatment
The control patients were only placed needles at the bilateral Neiguan (PC 6)acupoints without electric stimulus.
| Study group | Role | What they receive |
|---|---|---|
| Pretreatment | Experimental | Not described Receives: Procedure: Electroacupuncture stimulation |
| Control | No intervention | Not described Receives: Procedure: No intervention |
What is being measured
The primary outcome is the main question the study is designed to answer.
The primary outcome was assessing whether EA pretreatment before elective PCI reduced cTnI concentration at 48 hours.
Measured: 48 hours after PCI
Secondary outcomes (1)
Secondary outcomes were the effect of EA pretreatment on ischemic symptoms, ECG evidence of ischemia during coronary balloon occlusion, CRP,and major adverse cardiac events (MACE) at 6 months.
Measured: six months of PCI follow-up.
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted26 Nov 2009 (estimated)
- Study startJan 2010
- Primary completionDec 2011 (estimated)
- Study completionJun 2012 (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 Myocardial InjuryStudies 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
- Investigator, Outcomes assessor
- Enrolment
- 500 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Xijing Hospital
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Lize Xiong, M.D., Ph.D., Study director, Xijing Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01020942
- Sponsor's protocol ID
- XJMZK016
- Status last verified
- Nov 2011
- First submitted
- 24 Nov 2009
- Last updated
- 16 Dec 2011
- Results posted
- No
- Data monitoring committee
- Yes
Publications
Wang Q, Liang D, Wang F, Li W, Han Y, Zhang W, Xie Y, Xin W, Zhou B, Sun D, Cao F, Xiong L. Efficacy of electroacupuncture pretreatment for myocardial injury in patients undergoing percutaneous coronary intervention: A randomized clinical trial with a 2-year follow-up. Int J Cardiol. 2015 Sep 1;194:28-35. doi: 10.1016/j.ijcard.2015.05.043. Epub 2015 May 13.
PubMed 26011261
Study at a glance
From the registry record, last updated by the sponsor on 16 Dec 2011. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Cardioprotective of Electroacupuncture Pretreatment in Patients Underwent Coronary Stenting: A Prospective, Multicenter, Randomized Control Trial
- ClinicalTrials.gov ID
- NCT01020942
- Acronym / sponsor ID
- XJMZK016
- Conditions
- Myocardial Injury
- Keywords
- ischemia, myocardial infarction, prognosis, pretreatment, electroacupuncture, stents, troponin, percutaneous coronary intervention
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 500 participants (estimated)
- Lead sponsor
- Xijing HospitalUniversity, hospital or other
- Study start
- Jan 2010
- Primary completion
- Dec 2011 (estimated)
- Study completion
- Jun 2012 (estimated)
- First posted
- 26 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.
Myocyte necrosis as a result of elective percutaneous coronary intervention (PCI) occurs in approximately one third of cases and is associated with subsequent cardiovascular events. This study assesses the ability of electroacupuncture (EA) pretreatment to attenuate cardiac troponin I (cTnI) release after elective PCI.
Detailed description
Elective percutaneous coronary intervention (PCI) is associated with troponin release in approximately one third of cases.Troponin release is a sensitive and specific marker of myocyte necrosis and infarction resulting from a form of ischemia/reperfusion injury, downstream embolization of atheromatous material, and coronary side-branch occlusion. A number of studies have demonstrated that procedure-related troponin release is associated with subsequent cardiovascular events.
Transient sublethal episodes of ischemia before a prolonged ischemia/reperfusion injury, known as ischemic preconditioning (IPC), have been shown to reduce the extent of myocardial infarction (MI).Electroacupuncture (EA) stimulus, as a pretreatment method, limits MI size in animal models. However, there are limited outcome to demonstrate protection from EA pretreatment during PCI. The present study investigated the ability of EA pretreatment to attenuate cardiac troponin I (cTnI) release after elective PCI in a single-center, randomized controlled trial.
Study design
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind (investigator, outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Pretreatment | Experimental | Procedure: Electroacupuncture stimulation |
| Control | No intervention | Procedure: No intervention |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (1 listed)
- All patients > 18 of age who are undergoing elective PCI and are able to give informed consent are eligible for study.
Key exclusion criteria (5 listed)
- Emergency PCI,
- Elevation of cTnI before PCI taken at the preadmission clinic,
- Women of child-bearing age,
- Nicorandil or glibenclamide use (preconditioning-mimetic and preconditioning blocking medication, respectively), and
- Severe comorbidity (estimated life expectancy < 6 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 |
|---|---|---|
| Electroacupuncture stimulationAlso: PreconditioningAccording to the theory of traditional Chinese medicine, bilateral Neiguan (PC 6) acupoints were chosen and identified according to traditional anatomical localizations. Once insertion of original needles was made at the acupoints, the needle was stimulated electrically with the intensity of 2-6 mA and frequency of 2/30 Hz using the Electronic Acupuncture Treatment Instrument until the patient felt the so-called 'Teh Chi' sensation of heaviness, numbness and swelling. The pretreatment was individualized based on patients sex, age, weight and felt and given 1 time per day for 5 consecutive days before the heart valve replacement surgery． | Procedure or surgery | Pretreatment |
| No interventionAlso: Sham pretreatmentThe control patients were only placed needles at the bilateral Neiguan (PC 6)acupoints without electric stimulus. | Procedure or surgery | Control |
Primary outcome
The primary outcome was assessing whether EA pretreatment before elective PCI reduced cTnI concentration at 48 hours.
Time frame: 48 hours after PCI
1 secondary outcome
Secondary outcomes were the effect of EA pretreatment on ischemic symptoms, ECG evidence of ischemia during coronary balloon occlusion, CRP,and major adverse cardiac events (MACE) at 6 months.
Time frame: six months of PCI follow-up.
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 16 Dec 2011.
- Derived from this study: PubMed 26011261Wang Q, Liang D, Wang F, Li W, Han Y, Zhang W, Xie Y, Xin W, Zhou B, Sun D, Cao F, Xiong L. Efficacy of electroacupuncture pretreatment for myocardial injury in patients undergoing percutaneous coronary intervention: A randomized clinical trial with a 2-year follow-up. Int J Cardiol. 2015 Sep 1;194:28-35. doi: 10.1016/j.ijcard.2015.05.043. Epub 2015 May 13.
Related trials for Myocardial Injury
RecruitingPhase 2
Prevention of Reperfusion Injury Outcomes Through Effective Cardioprotection Targeting Myocardial Infarction
Myocardial Infarction, Reperfusion Injury
Not yet recruitingPhase 2
Evaluating SGLT2 Inhibitors for the Reduction of No-Reflow Phenomenon in Patients Undergoing PCI
No Reflow Phenomenon, Reperfusion Injuries, Myocardial
Recruiting
CRP Apheresis in STEMI
ST Elevation Myocardial Infarction, C-Reactive Protein
Not yet recruitingObservational study
High-Sensitivity Troponin T Kinetics and 30-Day Outcomes After Major Abdominal Surgery (TROP-MAS)
Myocardial Infarction (MI), Perioperative Myocardial Injury
RecruitingObservational study
Incidence and Outcome of Perioperative Myocardial Injury After Non-cardiac Surgery
Perioperative Myocardial Injury
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., 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 Electroacupuncture stimulation in people with Myocardial Injury, 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 5 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 16 Dec 2011. 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?
The primary outcome was assessing whether EA pretreatment before elective PCI reduced cTnI concentration at 48 hours. (time frame: 48 hours after PCI). 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 NCT01020942, 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 16 Dec 2011; AzTrials last refreshed its copy on 8 Nov 2026.