Overview

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

Status:
Completed
Trial end date:
2003-08-18
Target enrollment:
0
Participant gender:
All
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).
Phase:
Phase 2/Phase 3
Accepts Healthy Volunteers?
No
Details
Lead Sponsor:
Imperial College London
Treatments:
Genistein
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