Isoflavones and the Coronary Circulation in Men and Women With Coronary Artery Disease

Study Overview
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Brief Summary
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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).

Official Title
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The Effect of Genistein (Supro®) on Coronary Artery Diameter and Blood Flow in Men and Women With Coronary Heart Disease

Conditions
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Coronary Artery Disease

Intervention / Treatment
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* Drug: Genistein
* Drug: Placebo


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: 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 Exclusion Criteria: Age <30 or >75 years Allergy to radiographic contrast media Sino-atrial disease or significant bradycardia Concomitant medication with persantin (dipyridamole) or theophyllines Asthma 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

Ages Eligible for Study
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Minimum Age: 30 Years
Maximum Age: 75 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Quadruple


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Genistein<br>Supro drink once daily for 3 days | Drug: Genistein<br>* Drink taken once daily<br>* Other names: Supro;|
| Placebo Comparator: Placebo<br>Drink identical to Supro but containing no genistein, once daily for 3 days | Drug: Placebo<br>* Drink taken once daily<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Coronary Artery Diameter | 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). | Day 3-4 after Supro/placebo started. | 
| Coronary Blood Flow | 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). | Day 3-4 after Supro/placebo started. | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Serum Genistein Concentrations | Measured from serum using liquid-chromatographic tandem mass spectrometric bioanalytical assays (HFL Ltd, Fordham, Cambridgeshire, UK). | Day 3 after Supro/placebo started. | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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arteries, blood flow, coronary artery disease, diet