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

Coronary Artery Disease Clinical Trial

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT00287690
• Other study ID #: 98-170
• Status: Completed
• Phase: Phase 2/Phase 3
• Start date: October 1999
• Est. completion date: August 18, 2003

Study information

• Verified date: February 2006
• Source: Imperial College London
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial Summary

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).

Recruitment information / eligibility

• Status: Completed
• Enrollment: 71
• Est. completion date: August 18, 2003
• Est. primary completion date: August 18, 2003
• Accepts healthy volunteers: No
• Gender: All
• Age group: 30 Years to 75 Years

Eligibility

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

Related Conditions & MeSH terms

• Coronary Artery Disease
• Coronary Disease
• Myocardial Ischemia

Intervention

Drug:
• Genistein
Drink taken once daily
• Placebo
Drink taken once daily

Locations

Country	Name	City	State
United Kingdom	Royal Brompton & Harefield NHS Trust	London

Sponsors (1)

Lead Sponsor	Collaborator
Imperial College London

Country where clinical trial is conducted

United Kingdom, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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.
Primary	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	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.