NCT02520466已完成不适用
Effect of Cocoa Flavanol-containing Drink on Coronary Vascular Function in Patients With Coronary Artery Disease
适应症
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 37
- 试验地点
- 2
- 主要终点
- coronary endothelial function as assessed as response to cold pressor test
研究概览
简要总结
The aim of the present study is to investigate whether the ingestion of a cocoa flavanol-containing drink compared to a flavanol-free drink, improves coronary vasomotion and platelet function in patients with overt coronary artery disease acutely (after 2 hours)
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Other
- 盲法
- Double (Participant, Investigator)
入排标准
- 年龄范围
- 20 Years 至 80 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Patients with coronary artery disease undergoing elective coronary angiography with or without the need of coronary intervention
- •Age 20 - 80
- •Written obtained informed consent
排除标准
- •Acute ST-elevation myocardial infarction
- •Acute non-ST-elevation myocardial infarction (enzyme positive)
- •Ventricular tachy-arrythmias or AV-Block >I°
- •Renal insufficiency (GFR MDRD < 30ml/min) or liver disease (ALT or AST >150 IU)
- •Pregnancy
- •Known allergy to compounds of cocoa product
- •Known allergy to contrast media
- •Known allergy to nuts
- •Intolerance to coffein and theobromin
- •Acute infectious disease
- •Disease with systemic inflammation (e.g. rheumatoid arthritis, M. Crohn)
- •Participation in another study within the last month
- •Concomitant vitamin supplements and herbal remedies, as well as fruit and tea extracts
- •No study visits ± 1 week before Eastern, Christmas and New Year holyday (altered eating habits)
- •Extreme eating habits (as assessed by a questionnaire)
- •Alcohol or drug abuse
- •Lactose intolerance
结局指标
主要结局
coronary endothelial function as assessed as response to cold pressor test
时间窗: 2 hours
Primary endpoint will be the improvement in coronary endothelial function in response to cold pressor testing (i.e. % reduction in coronary artery constriction compared to baseline) 2h after ingestion of a cocoa flavanol rich-drink or placebo drink, respectively. In a subset of patients daily consumption of a flavanol-drink will be assessed and outcomes measured after 3-4 weeks.
次要结局
未报告次要终点
研究者
研究点 (2)
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