Ignite Creation Date:
2024-05-06 @ 6:01 PM
Last Modification Date:
2024-10-26 @ 2:40 PM
Study NCT ID:
NCT05514067
Status:
RECRUITING
Last Update Posted:
2023-08-02
First Post:
2022-05-16
Brief Title:
Electroacupuncture for Heart Protection Clinical Application in Patients Undergoing Cardiac Bypass Surgery
Sponsor:
National Heart Centre Singapore
Organization:
National Heart Centre Singapore
Study Overview
Official Title:
Electroacupuncture for Heart Protection Clinical Application in Patients Undergoing Cardiac Bypass Surgery
Status:
RECRUITING
Status Verified Date:
2023-07
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
EA-CABG
Brief 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 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 ischaemiareperfusion 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 N30 or standard care N30 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 factors 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
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 N30 or standard care N30 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 factors 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 Oversight
Has Oversight DMC:
None
Is a FDA Regulated Drug?:
False
Is a FDA Regulated Device?:
False
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?:
None