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

This study has been completed.

First Received: February 6, 2006 Last Updated: May 23, 2006 History of Changes

Sponsored by:	Imperial College London
Information provided by:	Imperial College London
ClinicalTrials.gov Identifier:	NCT00287690

Purpose

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).

Condition	Intervention	Phase
Coronary Artery Disease	Drug: genistein (Supro)	Phase II Phase III

MedlinePlus related topics: Coronary Artery Disease Diets Heart Diseases

Drug Information available for: Genistein

U.S. FDA Resources

Study Type:	Interventional
Study Design:	Treatment, Randomized, Double-Blind, Placebo Control, Parallel Assignment, Safety Study
Official Title:	The Effect of Genistein (Supro®) on Coronary Artery Diameter and Blood Flow in Men and Women With Coronary Heart Disease

Further study details as provided by Imperial College London:

Primary Outcome Measures:

Coronary artery diameter

Secondary Outcome Measures:

Coronary blood flow

Estimated Enrollment:	26
Study Start Date:	October 1999
Estimated Study Completion Date:	April 2003

Eligibility

Ages Eligible for Study:	30 Years to 75 Years
Genders Eligible for Study:	Both
Accepts Healthy Volunteers:	No

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

Contacts and Locations

Please refer to this study by its ClinicalTrials.gov identifier: NCT00287690

Locations

United Kingdom
Royal Brompton & Harefield NHS Trust
London, United Kingdom, SW3 6NP

Sponsors and Collaborators

Imperial College London

Investigators

Principal Investigator:

Peter Collins, MD, FRCP

Imperial College London

More Information

No publications provided

Study ID Numbers:	98-170
Study First Received:	February 6, 2006
Last Updated:	May 23, 2006
ClinicalTrials.gov Identifier:	NCT00287690 History of Changes
Health Authority:	United Kingdom: Research Ethics Committee

Keywords provided by Imperial College London:

arteries
blood flow
coronary artery disease
diet

Study placed in the following topic categories:

Anticarcinogenic Agents
Arterial Occlusive Diseases
Estrogens
Heart Diseases
Hormone Antagonists
Myocardial Ischemia
Vascular Diseases
Hormones, Hormone Substitutes, and Hormone Antagonists

Ischemia
Arteriosclerosis
Protein Kinase Inhibitors
Hormones
Coronary Disease
Phytoestrogens
Coronary Artery Disease
Genistein

Additional relevant MeSH terms:

Anticarcinogenic Agents
Arterial Occlusive Diseases
Estrogens
Heart Diseases
Molecular Mechanisms of Pharmacological Action
Antineoplastic Agents
Myocardial Ischemia
Physiological Effects of Drugs
Hormones, Hormone Substitutes, and Hormone Antagonists
Vascular Diseases
Enzyme Inhibitors
Arteriosclerosis

Protein Kinase Inhibitors
Protective Agents
Hormones
Pharmacologic Actions
Coronary Disease
Estrogens, Non-Steroidal
Therapeutic Uses
Phytoestrogens
Cardiovascular Diseases
Coronary Artery Disease
Genistein

ClinicalTrials.gov processed this record on May 07, 2009