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

NCT ID: NCT00287690

Last Updated: 2019-08-05

Study Results

Results available

Outcome measurements, participant flow, baseline characteristics, and adverse events have been published for this study.

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Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

PHASE2/PHASE3

Total Enrollment

71 participants

Study Classification

INTERVENTIONAL

Study Start Date

1999-10-31

Study Completion Date

2003-08-18

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).

Detailed Description

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Conditions

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Coronary Artery Disease

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

TREATMENT

Blinding Strategy

QUADRUPLE

Participants Caregivers Investigators Outcome Assessors

Study Groups

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Genistein

Supro drink once daily for 3 days

Group Type EXPERIMENTAL

Genistein

Intervention Type DRUG

Drink taken once daily

Placebo

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

Group Type PLACEBO_COMPARATOR

Placebo

Intervention Type DRUG

Drink taken once daily

Interventions

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Genistein

Drink taken once daily

Intervention Type DRUG

Placebo

Drink taken once daily

Intervention Type DRUG

Other Intervention Names

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Supro

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
Minimum Eligible Age

30 Years

Maximum Eligible Age

75 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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Imperial College London

OTHER

Sponsor Role lead

Responsible Party

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Responsibility Role SPONSOR

Principal Investigators

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Peter Collins, MD, FRCP

Role: PRINCIPAL_INVESTIGATOR

Imperial College London

Locations

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Royal Brompton & Harefield NHS Trust

London, , United Kingdom

Site Status

Countries

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United Kingdom

Other Identifiers

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98-170

Identifier Type: -

Identifier Source: org_study_id

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