A randomised trial comparing high-dose thiamine to placebo in patients undergoing coronary artery bypass surgery with proliferation of resident cardiac progenitor cells as measured by bromodeoxyuridine (BrdU) assay as primary outcome
试验速览
- 阶段
- 2 期
- 状态
- 已完成
- 入组人数
- 42
研究概览
简要总结
The heart’s intrinsic capability to repair itself is related to the presence and function of resident cardiac progenitor cells (CPCs). CPCs are cells that reside in the heart and can orchestrate this repair process. There are limited ways of improving this capability. In earlier lab based studies, we have shown that a thiamine like medicine increases the ability of these CPCs to proliferate. People having coronary artery bypass grafting (CABG) have narrowed heart (coronary) arteries, and are more likely to have worse heart function. In this trial, we aimed to test whether, in humans, giving high dose thiamine for three to five days to people before heart surgery (CABG) would improve the proliferation ability of CPCs. As part of the heart operation, a small part of the heart was taken to the laboratory, and the CPCs isolated and tested. 42 people (average age 65 years) were analysed in the study, and they were randomly given thiamine or a matching placebo (inactive tablet). We found that high dose thiamine did not improve the proliferation ability of CPCs. Thiamine did increase the proportion of CPCs with a cell marker called endoglin, which helps with developing new blood vessels. Thiamine also increased the power generated by isolated heart muscle, in a subgroup of people where we could test this. Overall, these results did not confirm our earlier studies. However, they encourage more lab based investigation into how CPCs work, considering another trial of thiamine in humans.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomised controlled trial
- 主要目的
- Treatment
- 盲法
- Blinded (masking used)
入排标准
- 年龄范围
- 50 Years 至 o limit（—）
- 性别
- All
入选标准
- •1.Patients listed for inpatient coronary artery bypass surgery due to atherosclerotic coronary artery disease and
- •2.Aged 50 years and over and
- •3.Left ventricular systolic function normal on echocardiography (ejection fraction more than or equal to 50%) performed during this inpatient stay (or within three months if no myocardial infarction has occurred between date of echocardiogram and date of enrollment).
排除标准
- •1.Left ventricular systolic function impaired (echocardiographic ejection fraction < 50%) or
- •2.Renal failure with creatinine > 200 umol/l or requiring renal replacement therapy or
- •3.Already taking thiamine supplementation or
- •4.Previously had an adverse reaction to thiamine, or a supplement or medication containing thiamine or
- •5.Previous or current history of alcohol related problems. This refers to a previous diagnosis of a medical condition thought to be caused or exacerbated by alcohol, or harmful use of alcohol (International Classification of Diseases version 10 codes F10.0 to F10.9) or
- •6.Other major medical conditions that, in the opinion of the investigator, would make randomisation of the participant to thiamine unsafe or undesirable.