Electroacupuncture for Heart Protection: Clinical Application in Patients Undergoing Cardiac Bypass Surgery

NCT05514067 | Completed

• 1 other identifier: 2020/2028
• Study Type: interventional
• Target: 10
• Locations: 1 country
• Sites: 1

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 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.

Conditions

Coronary Artery Disease; Electro-Acupuncture

Outcome Measures

Primary Outcomes (4)

• 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.

  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.

  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.

  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.

  Blood samples will be taken at 48 hours (post coming off bypass).

Secondary Outcomes (3)

• Any Acute Kidney Injury

  Urine output will be measured over the 3 day peri-operative period to derive the AKI grade.

• Change in Cognitive Function measure

  MMSE will be conducted prior to surgery, postoperative day 3 and postoperative week 6.

• Change in Quality of life measure

  The questionnaire will be done prior to surgery, postoperative day 3 and postoperative week 6.

Study Arms (2)

Electro-acupuncture (EA) arm

EXPERIMENTAL

Patients with stable CAD going for coronary artery bypass graft (CABG) surgery randomized to receive EA before surgery.

Procedure: Electro-Acupuncture

Standard Care arm

NO INTERVENTION

Patients with stable CAD going for coronary artery bypass graft (CABG) surgery.

Interventions

Electro-Acupuncture PROCEDURE

A single application of EA at cardiac-related acupoints administered for 30 min prior to CABG surgery.

Electro-acupuncture (EA) arm

Eligibility Criteria

• Age: 21 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Patients with stable CAD undergoing planned CABG surgery on cardiopulmonary bypass using blood cardioplegia.
• Patients aged 21 years and above.

You may not qualify if:

• 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.

Sponsors & Collaborators

• National Heart Centre Singapore: lead

Study Sites (1)

National Heart Centre Singapore

Singapore, 169609, Singapore

Location

MeSH Terms

Conditions

Coronary Artery Disease

Condition Hierarchy (Ancestors)

Coronary Disease; Myocardial Ischemia; Heart Diseases; Cardiovascular Diseases; Arteriosclerosis; Arterial Occlusive Diseases; Vascular Diseases

Study Officials

• Derek Hausenloy, PHD

  National Heart Centre Singapore

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Masking Details: After obtaining consent, patient's study arm will be revealed via sequentially numbered, opaque, sealed and stapled envelopes.
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Model Details: Patients will then be randomised 1:1 to receive either the EA or standard care protocols.

Study Record Dates

• First Submitted: May 16, 2022
• First Posted: August 24, 2022
• Study Start: July 9, 2020
• Primary Completion: November 14, 2023
• Study Completion: November 14, 2023
• Last Updated: October 29, 2024

Record last verified: 2024-10

Locations

SG (1)