Hypotheses, rationale, design, and methods for evaluation of a randomized controlled trial using Tocotrienol, an isomer of Vitamin E derived from palm oil, on the prevention of atrial fibrillation after coronary artery bypass grafting surgery

Background: One of the most common complications following coronary artery bypass grafting (CABG) surgery is atrial fibrillation (AF), which contributes towards increasing morbidity and mortality, length of hospital stay (LoHS) and reduced quality of life (QoL) of patients. Objectives: To determine whether the intake of Tocotrienol, a Vitamin E isomer derived from palm oil, before and immediately following CABG prevents AF, reduces LoHS, and improves the QoL of patients. Protocol: The study is registered with the National Medical Research Register with a trial number NMRR-17-1994-34963 and designed as a prospective, randomized controlled trial (RCT) with parallel groups. The experimental group will receive two 200mg Tocotrienol capsules each day, while the control group will receive two identical placebo (palm Super Olein) capsules per day. ECG readings will be used to detect AF post operatively, LoHS will be measured by checking the records from the National Heart Institute Hospital register, and the health-related Quality of Life (HRQoL) analysis (the Malay version of the Short Form 36 Questionnaire) will be used to analyse QoL. The sample size was calculated to be 140 in each arm of the RCT for a power of 0.8 and a significance level of 0.05. Funding: HOVID Berhad funds this research project. Expected outcomes: The primary endpoint is the development of postoperative AF, whilst the secondary endpoints are the LoHS and HRQoL of patients post CABG. Future implications: Prevention of AF and its complications such as cardiovascular or cerebrovascular events, especially stroke, is an important output. Malaysia is one of the biggest producers and exporters of palm oil and palm oil products. Thus, the possibility of marketing Tocotrienol, in reducing AF post CABG surgery, is a very important proposition indeed. Trial number: NMRR-17-1994-34963

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A study protocol for a randomized controlled trial on the prevention of atrial fibrillation after coronary artery bypass grafting surgery using Tocotrienol, an isomer of Vitamin E derived from palm oil

F1000Research ◽

10.12688/f1000research.12912.1 ◽

2018 ◽

Vol 7 ◽

pp. 215

Author(s):

Ahmad Farouk Musa ◽

Jeswant Dillon ◽

Mohamed Ezani Md Taib ◽

Alwi Mohamed Yunus ◽

Rusli Bin Nordin ◽

...

Keyword(s):

Quality Of Life ◽

Atrial Fibrillation ◽

Randomized Controlled Trial ◽

Coronary Artery ◽

Palm Oil ◽

Controlled Trial ◽

Artery Bypass ◽

Bypass Grafting ◽

Randomized Controlled

Background: One of the most common complications following coronary artery bypass grafting (CABG) surgery is atrial fibrillation (AF), which contributes towards increasing morbidity and mortality, length of hospital stay (LoHS) and reduced quality of life (QoL) of patients. Objectives: To determine whether the intake of Tocotrienol, a Vitamin E isomer derived from palm oil, before and immediately following CABG prevents AF, reduces LoHS, and improves the QoL of patients. Protocol: The study is registered with the National Medical Research Register with a trial number NMRR-17-1994-34963 and designed as a prospective, randomized controlled trial (RCT) with parallel groups. The experimental group will receive two 200mg Tocotrienol capsules each day, while the control group will receive two identical placebo (palm Super Olein) capsules per day. ECG readings will be used to detect AF post operatively, LoHS will be measured by checking the records from the National Heart Institute Hospital register, and the health-related Quality of Life (HRQoL) analysis (the Malay version of the Short Form 36 Questionnaire) will be used to analyse QoL. The sample size was calculated to be 140 in each arm of the RCT for a power of 0.8 and a significance level of 0.05. Funding: HOVID Berhad funds this research project. Expected outcomes: The primary endpoint is the development of postoperative AF, whilst the secondary endpoints are the LoHS and HRQoL of patients post CABG. Future implications: Prevention of AF and its complications such as cardiovascular or cerebrovascular events, especially stroke, is an important output. Malaysia is one of the biggest producers and exporters of palm oil and palm oil products. Thus, the possibility of marketing Tocotrienol, in reducing AF post CABG surgery, is a very important proposition indeed. Trial number: NMRR-17-1994-34963

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PT009 Effect of preaortic fat pad removal on atrial fibrillation post off-pump coronary artery bypass grafting (CABG): A randomized controlled trial

Global Heart ◽

10.1016/j.gheart.2014.03.1820 ◽

2014 ◽

Vol 9 (1) ◽

pp. e166

Author(s):

Neda Fotoohi ◽

Masoud Mirzaei ◽

Mehdi Haddadzadeh

Keyword(s):

Atrial Fibrillation ◽

Randomized Controlled Trial ◽

Coronary Artery ◽

Controlled Trial ◽

Artery Bypass ◽

Bypass Grafting ◽

Fat Pad ◽

Off Pump ◽

Randomized Controlled ◽

Pump Coronary Artery Bypass

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GW29-e1949 Early rehabilitation therapy improves functional outcomes and quality of life in elderly patients after coronary artery bypass surgery: a three-armed randomized controlled trial

Journal of the American College of Cardiology ◽

10.1016/j.jacc.2018.08.1014 ◽

2018 ◽

Vol 72 (16) ◽

pp. C237-C238

Author(s):

Hairui Yu ◽

Qi Guo

Keyword(s):

Quality Of Life ◽

Randomized Controlled Trial ◽

Coronary Artery ◽

Functional Outcomes ◽

Coronary Artery Bypass Surgery ◽

Bypass Surgery ◽

Controlled Trial ◽

Artery Bypass ◽

Randomized Controlled

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Long-term Patency of Endoscopically Harvested Radial Arteries: From a Randomized Controlled Trial

Innovations Technology and Techniques in Cardiothoracic and Vascular Surgery ◽

10.1097/imi.0000000000000133 ◽

2015 ◽

Vol 10 (2) ◽

pp. 77-84 ◽

Cited By ~ 11

Author(s):

Daniel J.P. Burns ◽

Stuart A. Swinamer ◽

Stephanie A. Fox ◽

Jonathan Romsa ◽

William Vezina ◽

...

Keyword(s):

Quality Of Life ◽

Randomized Controlled Trial ◽

Radial Artery ◽

Controlled Trial ◽

Artery Bypass ◽

Graft Patency ◽

Bypass Grafting ◽

Randomized Controlled

Objective From 2005 to 2007, 119 patients were enrolled in a prospective randomized controlled trial comparing open and endoscopically harvested radial arteries for coronary artery bypass grafting. The objective of the current study was to compare graft patency between intervention groups at more than 5 years from the initial trial. We hypothesized that endoscopically harvested radial arteries would show equivalent patency to those conventionally harvested. Methods At 5 years or greater from their operation, all consenting patients underwent a single-day anatomic and functional cardiac assessment with coronary computed tomography angiography and sestamibi myocardial perfusion scanning. Medical Outcomes Study 36-Item Short-Form Health Surveys and Seattle Angina Questionnaires were completed to assess the overall quality of life. All patients had received calcium channel blocker therapy for at least 6 months postoperatively. Results The mean (SD) duration of follow-up was 79.2 (8.6) months for all patients. One death occurred within 30 days of coronary artery bypass grafting in each treatment group, and eight additional noncardiac deaths occurred during the study time frame. Of 119 patients, 66 consented to follow-up. Thirty-two had open radial artery harvest, and 34 had endoscopic radial artery harvest. At more than 5 years, there were 28 patent conventionally harvested radial arteries (87.5%) and 31 patent endoscopically harvested radial arteries (91.2%) ( P = 0.705). Measured quality of life was comparable between groups. Conclusions Endoscopic radial artery harvest is safe and effective when compared with open radial artery harvest, with excellent graft patency demonstrated at more than 5 years. Patency results are noninferior in endoscopic radial artery harvest.

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