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

Imperial College London

Status and phase

Completed

Phase 3

Phase 2

Conditions

Coronary Artery Disease

Treatments

Drug: Placebo

Drug: Genistein

Study type

Interventional

Funder types

Other

Identifiers

NCT00287690

98-170

Details and patient eligibility

About

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).

Enrollment

71 patients

Sex

All

Ages

30 to 75 years old

Volunteers

No 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