Coronary Artery DiseaseEA-CABGNCT05514067
Electroacupuncture for Heart Protection: Clinical Application in Patients Undergoing Cardiac Bypass Surgery
A study testing Electro-Acupuncture in people with Coronary Artery Disease and Electro-Acupuncture, run by National Heart Centre Singapore at 1 site in Singapore.
Trial summary
Coronary artery disease (CAD) is the leading cause of death and disability in Singapore and worldwide. Many patients with multi-vessel CAD require surgical revascularisation by coronary artery bypass graft (CABG) surgery, and are at risk of postsurgical complications such as peri-operative myocardial injury (PMI)… Read more about this study
- Who is it for?
- Ages 21 years and older
- Conditions the study is for
- Coronary Artery Disease, Electro-Acupuncture
- What is being tested?
- Electro-Acupuncture
- Type of treatment
- Surgery or procedure
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 10 participants
- Where
- 1 siteSingapore
- Study dates
- 9 Jul 2020to 14 Nov 2023
- 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 21 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Patients with stable CAD undergoing planned CABG surgery on cardiopulmonary bypass using blood cardioplegia.
- Patients aged 21 years and above.
Who cannot join
- Patients with recent myocardial infarction (<30 days)
- Patients with significant hepatic dysfunction (If available, INR>2)
- Patients with significant pulmonary disease (If available, FEV1<40% predicted). - Patients with known renal failure with a GFR≤30 mL/min/1.73 m2.
- Patients recruited into another study which may impact on this study.
Trial locations and contacts
1 site in 1 country.
About this study
Coronary artery disease (CAD) is the leading cause of death and disability in Singapore and worldwide. Many patients with multi-vessel CAD require surgical revascularisation by coronary artery bypass graft (CABG) surgery, and are at risk of postsurgical complications such as peri-operative myocardial injury (PMI), left ventricular dysfunction, heart failure, and death. This risk is particularly important given that the aging population, and increased prevalence of co-morbidities (diabetes, hypertension, renal failure) and complexity of cardiac surgery, mean that higher risk patients are undergoing CABG surgery. As such, new treatment strategies are required to protect the heart during CABG surgery in order to improve health outcomes in patients with CAD. In this regard, a number of animal studies have demonstrated that electroacupuncture (EA) at cardiac-related acupoints can protect the heart against the detrimental effects of acute ischaemia/reperfusion injury (IRI). However, the mechanisms underlying the beneficial effect of EA, and whether EA can protect the heart against PMI in patients undergoing CABG surgery are not known. Therefore, in this research proposal, the investigators will investigate whether EA at cardiac-related acupoints can protect the heart against PMI during CABG surgery, and the investigators will elucidate the mechanisms underlying the cardioprotective effects of EA.
Read the detailed description
There are currently no effective therapies for protecting the heart against PMI during CABG surgery and therefore, new therapeutic interventions are required to reduce the magnitude of PMI, in order to preserve LV systolic function and improve health outcomes in CAD patients undergoing CABG surgery. In this regard, electroacupuncture (EA) may provide a novel treatment strategy for protecting the heart and reducing PMI during CABG surgery, and is investigated in this TCM research proposal. The magnitude of PMI can be quantified by measuring post-operative levels of serum cardiac biomarkers such CK-MB, Troponin-T, or Troponin-I, the release of which have been associated with worse clinical outcomes following CABG surgery.
This study aims to show the benefit of EA at cardiac-related acupoints in reducing injury to the heart in terms of less PMI in patients undergoing CABG surgery and also test the possibility that EA will have benefits in other organs in terms of less acute kidney injury and preserved cognitive function, given that the blood-borne humoral factors generated by EA may also be reno- and neuroprotective. As such, the findings for this research proposal will build on evidence for the safety and efficacy of EA in the clinical setting of CABG surgery for the benefit of patients with CAD. The expected clinical benefits of reducing PMI will include improvement in short term clinical outcomes in terms of preserving LV systolic function, preventing the onset of heart failure, and improving quality of life in patients undergoing CABG surgery. This study also intends to identify and assess the cardioprotective humoral factors generated by EA at cardiac-related acupoints in stable CAD and CABG patients, providing novel therapeutic strategies for cardioprotection. In this regard, the findings from this research proposal will add new knowledge in the field of EA cardioprotection.
60 stable CAD patients undergoing planned CABG surgery will be randomized to receive either EA at cardiac-related acupoints (N=30) or standard care (N=30). A single application of EA at cardiac-related acupoints will be administered for 30 min prior to surgery. For 10 recruited CABG patients administered EA, blood samples will be collected prior to and immediately following EA, and subjected to plasma proteomics analysis to identify the factor(s) which mediate EA cardioprotection. PMI will be measured as the 48-hour area under-the-curve serum high-sensitive Troponin-T. Blood samples will be taken at pre-op and 6, 12, 24, 48 hours (post-coming off cardiac bypass) for this evaluation.
- Conditions
- Coronary Artery Disease, Electro-Acupuncture
- Being tested
- Electro-Acupuncture
- Medical subject headings
- Coronary Artery Disease
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Electro-AcupunctureProcedure or surgery
A single application of EA at cardiac-related acupoints administered for 30 min prior to CABG surgery.
| Study group | Role | What they receive |
|---|---|---|
| Electro-acupuncture (EA) arm | Experimental | Patients with stable CAD going for coronary artery bypass graft (CABG) surgery randomized to receive EA before surgery. Receives: Procedure: Electro-Acupuncture |
| Standard Care arm | No intervention | Patients with stable CAD going for coronary artery bypass graft (CABG) surgery. |
What is being measured
The primary outcome is the main question the study is designed to answer.
Change of Troponin-T test result from baseline to 6 hours post-op (post coming off bypass) to assess the extend of peri-operative myocardial injury (PMI)
The investigators will be assessing the cardioprotective efficacy of EA at cardiac-related acupoints in terms of changing the magnitude of PMI when compared to standard care. PMI will be measured as the 48-hour area-under-the-curve serum high-sensitive Troponin-T.
Measured: Blood samples will be taken at pre-op and 6 hours (post coming off bypass).
Change of Troponin-T test result from 6 hours to 12 hours post-op (post coming off bypass) to assess the extend of peri-operative myocardial injury (PMI)
The investigators will be assessing the cardioprotective efficacy of EA at cardiac-related acupoints in terms of changing the magnitude of PMI when compared to standard care. PMI will be measured as the 48-hour area-under-the-curve serum high-sensitive Troponin-T.
Measured: Blood samples will be taken at 12 hours (post coming off bypass).
Change of Troponin-T test result from 12 hours to 24 hours post-op (post coming off bypass) to assess the extend of peri-operative myocardial injury (PMI)
The investigators will be assessing the cardioprotective efficacy of EA at cardiac-related acupoints in terms of changing the magnitude of PMI when compared to standard care. PMI will be measured as the 48-hour area-under-the-curve serum high-sensitive Troponin-T.
Measured: Blood samples will be taken at 24 hours (post coming off bypass).
Change of Troponin-T test result from 24 hours to 48 hours post-op (post coming off bypass) to assess the extend of peri-operative myocardial injury (PMI)
The investigators will be assessing the cardioprotective efficacy of EA at cardiac-related acupoints in terms of changing the magnitude of PMI when compared to standard care. PMI will be measured as the 48-hour area-under-the-curve serum high-sensitive Troponin-T.
Measured: Blood samples will be taken at 48 hours (post coming off bypass).
Secondary outcomes (3)
Any Acute Kidney Injury
The investigators will investigate the reno-protective effects of EA at cardiac-related acupoints by comparing the AKI grade following CABG surgery between the 2 study arms.
Measured: Urine output will be measured over the 3 day peri-operative period to derive the AKI grade.
Change in Cognitive Function measure
Patient cognitive function will be assessed using the Mini-Mental State Examination (MMSE) with a maximum score of 30. Higher scores reflect better outcomes.
Measured: MMSE will be conducted prior to surgery, postoperative day 3 and postoperative week 6.
Change in Quality of life measure
The EuroQol EQ-5D Health-Related Quality of Life questionnaire will be used to assess patient quality of life. Higher score given for health state imagined reflects better outcome.
Measured: The questionnaire will be done prior to surgery, postoperative day 3 and postoperative week 6.
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted24 Aug 2022
- Study start9 Jul 2020
- Primary completion14 Nov 2023
- Study completion14 Nov 2023
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Coronary Artery 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
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Model description
- Patients will then be randomised 1:1 to receive either the EA or standard care protocols.
- Masking
- None (open label)
- Enrolment
- 10 participants (actual)
Sponsor and investigators
- Lead sponsor
- National Heart Centre Singapore
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Derek Hausenloy, PHD, Principal investigator, National Heart Centre Singapore
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05514067
- Sponsor's protocol ID
- 2020/2028
- Acronym
- EA-CABG
- Status last verified
- Oct 2024
- First submitted
- 16 May 2022
- Last updated
- 29 Oct 2024
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 29 Oct 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Electroacupuncture for Heart Protection: Clinical Application in Patients Undergoing Cardiac Bypass Surgery
- ClinicalTrials.gov ID
- NCT05514067
- Acronym / sponsor ID
- EA-CABG / 2020/2028
- Conditions
- Coronary Artery Disease, Electro-Acupuncture
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 10 participants (actual)
- Lead sponsor
- National Heart Centre SingaporeUniversity, hospital or other
- Study start
- 9 Jul 2020 (actual)
- Primary completion
- 14 Nov 2023 (actual)
- Study completion
- 14 Nov 2023 (actual)
- First posted
- 24 Aug 2022 (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.
Coronary artery disease (CAD) is the leading cause of death and disability in Singapore and worldwide. Many patients with multi-vessel CAD require surgical revascularisation by coronary artery bypass graft (CABG) surgery, and are at risk of postsurgical complications such as peri-operative myocardial injury (PMI), left ventricular dysfunction, heart failure, and death. This risk is particularly important given that the aging population, and increased prevalence of co-morbidities (diabetes, hypertension, renal failure) and complexity of cardiac surgery, mean that higher risk patients are undergoing CABG surgery. As such, new treatment strategies are required to protect the heart during CABG surgery in order to improve health outcomes in patients with CAD. In this regard, a number of animal studies have demonstrated that electroacupuncture (EA) at cardiac-related acupoints can protect the heart against the detrimental effects of acute ischaemia/reperfusion injury (IRI). However, the mechanisms underlying the beneficial effect of EA, and whether EA can protect the heart against PMI in patients undergoing CABG surgery are not known. Therefore, in this research proposal, the investigators will investigate whether EA at cardiac-related acupoints can protect the heart against PMI during CABG surgery, and the investigators will elucidate the mechanisms underlying the cardioprotective effects of EA.
Detailed description
There are currently no effective therapies for protecting the heart against PMI during CABG surgery and therefore, new therapeutic interventions are required to reduce the magnitude of PMI, in order to preserve LV systolic function and improve health outcomes in CAD patients undergoing CABG surgery. In this regard, electroacupuncture (EA) may provide a novel treatment strategy for protecting the heart and reducing PMI during CABG surgery, and is investigated in this TCM research proposal. The magnitude of PMI can be quantified by measuring post-operative levels of serum cardiac biomarkers such CK-MB, Troponin-T, or Troponin-I, the release of which have been associated with worse clinical outcomes following CABG surgery.
This study aims to show the benefit of EA at cardiac-related acupoints in reducing injury to the heart in terms of less PMI in patients undergoing CABG surgery and also test the possibility that EA will have benefits in other organs in terms of less acute kidney injury and preserved cognitive function, given that the blood-borne humoral factors generated by EA may also be reno- and neuroprotective. As such, the findings for this research proposal will build on evidence for the safety and efficacy of EA in the clinical setting of CABG surgery for the benefit of patients with CAD. The expected clinical benefits of reducing PMI will include improvement in short term clinical outcomes in terms of preserving LV systolic function, preventing the onset of heart failure, and improving quality of life in patients undergoing CABG surgery. This study also intends to identify and assess the cardioprotective humoral factors generated by EA at cardiac-related acupoints in stable CAD and CABG patients, providing novel therapeutic strategies for cardioprotection. In this regard, the findings from this research proposal will add new knowledge in the field of EA cardioprotection.
60 stable CAD patients undergoing planned CABG surgery will be randomized to receive either EA at cardiac-related acupoints (N=30) or standard care (N=30). A single application of EA at cardiac-related acupoints will be administered for 30 min prior to surgery. For 10 recruited CABG patients administered EA, blood samples will be collected prior to and immediately following EA, and subjected to plasma proteomics analysis to identify the factor(s) which mediate EA cardioprotection. PMI will be measured as the 48-hour area under-the-curve serum high-sensitive Troponin-T. Blood samples will be taken at pre-op and 6, 12, 24, 48 hours (post-coming off cardiac bypass) for this evaluation.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
- Model description
- Patients will then be randomised 1:1 to receive either the EA or standard care protocols.
| Arm | Type | Receives |
|---|---|---|
| Electro-acupuncture (EA) arm | Experimental | Procedure: Electro-AcupuncturePatients with stable CAD going for coronary artery bypass graft (CABG) surgery randomized to receive EA before surgery. |
| Standard Care arm | No intervention | –Patients with stable CAD going for coronary artery bypass graft (CABG) surgery. |
Who may qualify
- Ages
- 21 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (2 listed)
- Patients with stable CAD undergoing planned CABG surgery on cardiopulmonary bypass using blood cardioplegia.
- Patients aged 21 years and above.
Key exclusion criteria (4 listed)
- Patients with recent myocardial infarction (<30 days)
- Patients with significant hepatic dysfunction (If available, INR>2)
- Patients with significant pulmonary disease (If available, FEV1<40% predicted). - Patients with known renal failure with a GFR≤30 mL/min/1.73 m2.
- Patients recruited into another study which may impact on this study.
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-AcupunctureA single application of EA at cardiac-related acupoints administered for 30 min prior to CABG surgery. | Procedure or surgery | Electro-acupuncture (EA) arm |
Primary outcome
Change of Troponin-T test result from baseline to 6 hours post-op (post coming off bypass) to assess the extend of peri-operative myocardial injury (PMI)
Time frame: Blood samples will be taken at pre-op and 6 hours (post coming off bypass).
The investigators will be assessing the cardioprotective efficacy of EA at cardiac-related acupoints in terms of changing the magnitude of PMI when compared to standard care. PMI will be measured as the 48-hour area-under-the-curve serum high-sensitive Troponin-T.
Change of Troponin-T test result from 6 hours to 12 hours post-op (post coming off bypass) to assess the extend of peri-operative myocardial injury (PMI)
Time frame: Blood samples will be taken at 12 hours (post coming off bypass).
The investigators will be assessing the cardioprotective efficacy of EA at cardiac-related acupoints in terms of changing the magnitude of PMI when compared to standard care. PMI will be measured as the 48-hour area-under-the-curve serum high-sensitive Troponin-T.
Change of Troponin-T test result from 12 hours to 24 hours post-op (post coming off bypass) to assess the extend of peri-operative myocardial injury (PMI)
Time frame: Blood samples will be taken at 24 hours (post coming off bypass).
The investigators will be assessing the cardioprotective efficacy of EA at cardiac-related acupoints in terms of changing the magnitude of PMI when compared to standard care. PMI will be measured as the 48-hour area-under-the-curve serum high-sensitive Troponin-T.
Change of Troponin-T test result from 24 hours to 48 hours post-op (post coming off bypass) to assess the extend of peri-operative myocardial injury (PMI)
Time frame: Blood samples will be taken at 48 hours (post coming off bypass).
The investigators will be assessing the cardioprotective efficacy of EA at cardiac-related acupoints in terms of changing the magnitude of PMI when compared to standard care. PMI will be measured as the 48-hour area-under-the-curve serum high-sensitive Troponin-T.
3 secondary outcomes
Any Acute Kidney Injury
Time frame: Urine output will be measured over the 3 day peri-operative period to derive the AKI grade.
Change in Cognitive Function measure
Time frame: MMSE will be conducted prior to surgery, postoperative day 3 and postoperative week 6.
Change in Quality of life measure
Time frame: The questionnaire will be done prior to surgery, postoperative day 3 and postoperative week 6.
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 29 Oct 2024.
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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.
Derek Hausenloy, PHD principal investigator
National Heart Centre Singapore
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Electro-Acupuncture in people with Coronary Artery Disease and Electro-Acupuncture, run by National Heart Centre Singapore at 1 site in Singapore.
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 4 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 29 Oct 2024. 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 Singapore. 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?
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?
Change of Troponin-T test result from baseline to 6 hours post-op (post coming off bypass) to assess the extend of peri-operative myocardial injury (PMI) (time frame: Blood samples will be taken at pre-op and 6 hours (post coming off bypass).). The study lists 4 primary outcomes in all. 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 29 Oct 2024.