The Effect of Genistein (Supro®) on Coronary Artery Diameter and Blood Flow in Men and Women With Coronary Heart Disease
试验速览
- 阶段
- 2 期
- 状态
- 已完成
- 入组人数
- 71
- 试验地点
- 1
- 主要终点
- Coronary Blood Flow
研究概览
简要总结
The aim of this study is to investigate the effect of genistein administration on coronary arteries in humans. We will measure the size of a coronary artery and the speed and amount of blood flow in response after subjects have ingested Supro® drinks (a soy protein drink containing genistein).
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
- Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
入排标准
- 年龄范围
- 30 Years 至 75 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Aged 30-75 years
- •Patients requiring diagnostic coronary angiography
- •Presence of coronary artery disease on angiogram but with at least one non-obstructed (lesions <70% narrowed compared with the adjacent normal part of the vessel) atheromatous vessel (confirmed at diagnostic cardiac catheterisation)
- •Female patients must be postmenopausal (FSH>40 IU/L)
- •Willing to give informed, written consent
排除标准
- •Age <30 or >75 years
- •Allergy to radiographic contrast media
- •Sino-atrial disease or significant bradycardia
- •Concomitant medication with persantin (dipyridamole) or theophyllines
- •Hypertension
- •Left ventricular hypertrophy or dysfunction (clinical/ECG/echo/CXR)
- •Female patients with FSH<40 IU/L (postmenopausal)
- •Female patients currently taking hormone therapy, or who have taken hormone therapy in previous 6 months
- •Unwilling to give written informed consent
- •Participation in another study within previous 60 days
研究组 & 干预措施
Genistein
Supro drink once daily for 3 days
干预措施: Genistein (Drug)
Placebo
Drink identical to Supro but containing no genistein, once daily for 3 days
干预措施: Placebo (Drug)
结局指标
主要结局
Coronary Blood Flow
时间窗: Day 3-4 after Supro/placebo started.
Measurement of diameter 4mm distal to the Doppler wire tip (measured using quantitative coronary angiography) and blood flow velocity, measured using intracoronary Doppler), were made at baseline and at peak velocity change. A quantitative estimate of coronary blood flow was calculated from the Doppler flow velocity and quantitative angiographic data using the following equation: Q = 3.14(D2/4)(APV/2)(0.6) where Q is flow (ml/min), D is vessel diameter (mm) and APV is average peak velocity (cm/s). Data below are measurements taken at peak blood flow response following an infusion of acetylcholine (10-5M).
Coronary Artery Diameter
时间窗: Day 3-4 after Supro/placebo started.
Coronary angiograms were acquired digitally using a real-time digital image acquisition system (Siemens AG, Berlin and Munich, Germany) and analysed off-line using quantitative coronary angiography (MEDIS, Leiden, The Netherlands). Basal luminal diameter of the entire coronary artery (mean luminal diameter) was measured for all subjects. Mean luminal diameter and luminal diameter approximately 4 mm distal to the tip of the Doppler wire were measured. The latter measurements were used to quantify volume flow as described previously. Data below are mean coronary artery diameter response following infusion of acetylcholine (ACh 10-5 M).
次要结局
- Serum Genistein Concentrations(Day 3 after Supro/placebo started.)