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

Imperial College London71 enrolled

Overview

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).

Study Type

INTERVENTIONAL

Allocation

RANDOMIZED

Purpose

TREATMENT

Masking

QUADRUPLE

Enrollment

Conditions

Coronary Artery Disease

Interventions

GenisteinDRUG

Drink taken once daily

PlaceboDRUG

Drink taken once daily

Eligibility

Sex: ALLMin age: 30 YearsMax age: 75 Years

Medical Language ↔ Plain English

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

Locations (1)

Royal Brompton & Harefield NHS Trust

London, United Kingdom

Outcomes

Primary Outcomes

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).

Time frame: 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).

Time frame: Day 3-4 after Supro/placebo started.

Secondary Outcomes

Serum Genistein Concentrations

Measured from serum using liquid-chromatographic tandem mass spectrometric bioanalytical assays (HFL Ltd, Fordham, Cambridgeshire, UK).

Time frame: Day 3 after Supro/placebo started.

Data from ClinicalTrials.gov

This platform is for informational purposes only and does not constitute medical advice. Always consult a qualified healthcare professional.