Isoflavones and the Coronary Circulation in Men and Women With Coronary Artery Disease
The Effect of Genistein (Supro®) on Coronary Artery Diameter and Blood Flow in Men and Women With Coronary Heart Disease
1 other identifier
interventional
71
1 country
1
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).
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P25-P50 for phase_2 coronary-artery-disease
Started Oct 1999
Typical duration for phase_2 coronary-artery-disease
1 active site
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
Click on a node to explore related trials.
Study Timeline
Key milestones and dates
Study Start
First participant enrolled
October 1, 1999
CompletedPrimary Completion
Last participant's last visit for primary outcome
August 18, 2003
CompletedStudy Completion
Last participant's last visit for all outcomes
August 18, 2003
CompletedFirst Submitted
Initial submission to the registry
February 6, 2006
CompletedFirst Posted
Study publicly available on registry
February 7, 2006
CompletedResults Posted
Study results publicly available
August 5, 2019
CompletedAugust 5, 2019
February 1, 2006
3.9 years
February 6, 2006
March 4, 2019
June 19, 2019
Conditions
Keywords
Outcome Measures
Primary Outcomes (2)
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 Outcomes (1)
Serum Genistein Concentrations
Day 3 after Supro/placebo started.
Study Arms (2)
Genistein
EXPERIMENTALSupro drink once daily for 3 days
Placebo
PLACEBO COMPARATORDrink identical to Supro but containing no genistein, once daily for 3 days
Interventions
Eligibility Criteria
You may qualify if:
- 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
You may not qualify if:
- 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
Contact the study team to confirm eligibility.
Sponsors & Collaborators
Study Sites (1)
Royal Brompton & Harefield NHS Trust
London, SW3 6NP, United Kingdom
MeSH Terms
Conditions
Interventions
Condition Hierarchy (Ancestors)
Intervention Hierarchy (Ancestors)
Results Point of Contact
- Title
- Dr Carolyn Webb
- Organization
- Imperial College London
Study Officials
- PRINCIPAL INVESTIGATOR
Peter Collins, MD, FRCP
Imperial College London
Publication Agreements
- PI is Sponsor Employee
- Yes
Study Design
- Study Type
- interventional
- Phase
- phase 2
- Allocation
- RANDOMIZED
- Masking
- QUADRUPLE
- Who Masked
- PARTICIPANT, CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
- Purpose
- TREATMENT
- Intervention Model
- PARALLEL
- Sponsor Type
- OTHER
- Responsible Party
- SPONSOR
Study Record Dates
First Submitted
February 6, 2006
First Posted
February 7, 2006
Study Start
October 1, 1999
Primary Completion
August 18, 2003
Study Completion
August 18, 2003
Last Updated
August 5, 2019
Results First Posted
August 5, 2019
Record last verified: 2006-02