Bilberry as a Dietary Supplement After Myocardial Infarction (The BEAR SMART Trial)
试验速览
- 阶段
- 4 期
- 状态
- 已完成
- 发起方
- 入组人数
- 50
- 试验地点
- 2
- 主要终点
- 6 minutes walk test
研究概览
简要总结
In a double blinded, randomized, clinical trial of patients suffering from STEMI (ST-segment elevation myocardial infarction) or non-STEMI (non-ST-segment elevation myocardial infarction)compare the effect of 3 months of dietary supplement with bilberry extract on a range of parameters with prognostic importance in cardiovascular disease: lipids, inflammation, oxidative stress and heart function.
Following inclusion of 8 individuals and as of February 12, 2014: Due to intolerance to "bilberry placebo powder" we have amended to the protocoll that the trial design is changed from blinded to open and that the bilberry arm of the trial carries on in an open design and that the control group will receive no dietary supplement.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Treatment
- 盲法
- Single (Outcomes Assessor)
入排标准
- 年龄范围
- 18 Years 至 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Patients with a diagnosis of STEMI as defined by chest pain suggestive for myocardial ischemia for at least 30 minutes before hospital admission, time from onset of symptoms of less than 24 hours, and an ECG with new ST-segment elevation in two or more contiguous leads of ≥0.2 mV in leads V2-V3 and/or ≥0.1 mV in other leads or a probable new-onset left bundle branch block.
- •Patients with a diagnosis of non-STEMI as defined by a combination of; onset of symptoms such as central chest pain or an aggravated angina pectoris, with or without an ECG change with ST-segment lowering or an inverted T-wave, and at least two values with levels of troponin-T or troponin-I above the established margin of an MI.
排除标准
- •Need for emergency coronary artery bypass grafting
- •Inability to provide informed consent
- •Age below 18 years
- •Previous randomization in the BEAR SMART trial
- •A daily intake, or the intent to start a daily intake of bilberries in some form (fresh berries, bilberry powder, bilberrysoup etc)
- •Exclusion Criteria:
- •Need for emergency coronary artery bypass grafting
- •Inability to provide informed consent
- •Age below 18 years
- •Previous randomization in the BEAR SMART trial
- •A daily intake, or the intent to start a daily intake of bilberries in some form (fresh berries, bilberry powder, bilberrysoup etc)
结局指标
主要结局
6 minutes walk test
时间窗: 2 months
The effect of intervention on a standardized physical challenge - the 6 minutes walk test
次要结局
- Inflammatory markers and markers of heart function(Baseline and 2 months)
- C-reactive protein(Baseline and 2 months)
研究者
Ole Frobert, MD, PhD
MD, PhD
Region Örebro County