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

Primary Purpose

Coronary Artery Disease

Status
Completed
Phase
Phase 2
Locations
United Kingdom
Study Type
Interventional
Intervention
Genistein
Placebo
Sponsored by
Imperial College London
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Coronary Artery Disease focused on measuring arteries, blood flow, coronary artery disease, diet

Eligibility Criteria

30 Years - 75 Years (Adult, Older Adult)All SexesDoes not accept healthy volunteers

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

Sites / Locations

  • Royal Brompton & Harefield NHS Trust

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

Placebo Comparator

Arm Label

Genistein

Placebo

Arm Description

Supro drink once daily for 3 days

Drink identical to Supro but containing no genistein, once daily for 3 days

Outcomes

Primary Outcome Measures

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).
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).

Secondary Outcome Measures

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

Full Information

First Posted
February 6, 2006
Last Updated
June 19, 2019
Sponsor
Imperial College London
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1. Study Identification

Unique Protocol Identification Number
NCT00287690
Brief Title
Isoflavones and the Coronary Circulation in Men and Women With Coronary Artery Disease
Official Title
The Effect of Genistein (Supro®) on Coronary Artery Diameter and Blood Flow in Men and Women With Coronary Heart Disease
Study Type
Interventional

2. Study Status

Record Verification Date
February 2006
Overall Recruitment Status
Completed
Study Start Date
October 1999 (undefined)
Primary Completion Date
August 18, 2003 (Actual)
Study Completion Date
August 18, 2003 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Imperial College London

4. Oversight

Data Monitoring Committee
No

5. Study Description

Brief 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).

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Coronary Artery Disease
Keywords
arteries, blood flow, coronary artery disease, diet

7. Study Design

Primary Purpose
Treatment
Study Phase
Phase 2, Phase 3
Interventional Study Model
Parallel Assignment
Masking
ParticipantCare ProviderInvestigatorOutcomes Assessor
Allocation
Randomized
Enrollment
71 (Actual)

8. Arms, Groups, and Interventions

Arm Title
Genistein
Arm Type
Experimental
Arm Description
Supro drink once daily for 3 days
Arm Title
Placebo
Arm Type
Placebo Comparator
Arm Description
Drink identical to Supro but containing no genistein, once daily for 3 days
Intervention Type
Drug
Intervention Name(s)
Genistein
Other Intervention Name(s)
Supro
Intervention Description
Drink taken once daily
Intervention Type
Drug
Intervention Name(s)
Placebo
Intervention Description
Drink taken once daily
Primary Outcome Measure Information:
Title
Coronary Artery Diameter
Description
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.
Title
Coronary Blood Flow
Description
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 Outcome Measure Information:
Title
Serum Genistein Concentrations
Description
Measured from serum using liquid-chromatographic tandem mass spectrometric bioanalytical assays (HFL Ltd, Fordham, Cambridgeshire, UK).
Time Frame
Day 3 after Supro/placebo started.

10. Eligibility

Sex
All
Minimum Age & Unit of Time
30 Years
Maximum Age & Unit of Time
75 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Peter Collins, MD, FRCP
Organizational Affiliation
Imperial College London
Official's Role
Principal Investigator
Facility Information:
Facility Name
Royal Brompton & Harefield NHS Trust
City
London
ZIP/Postal Code
SW3 6NP
Country
United Kingdom

12. IPD Sharing Statement

Learn more about this trial

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

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