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

Ahmad Farouk Musa, Jeswant Dillon, Mohamed Ezani Md Taib, Alwi Mohamed Yunus, Rusli Bin Nordin, Yuen Kah Hay

Research output: Contribution to journalArticleResearchpeer-review

Abstract

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.

Original languageEnglish
Article number215
Number of pages23
JournalF1000Research
Volume7
DOIs
Publication statusPublished - 2018

Keywords

  • Atrial Fibrillation
  • Coronary Artery Bypass

Cite this