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

This study has been completed.
Sponsor:
ClinicalTrials.gov Identifier:
NCT00287690
First Posted: February 7, 2006
Last Update Posted: October 22, 2015
The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
Information provided by:
Imperial College London
  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 Drug: Placebo Phase 2 Phase 3

Study Type: Interventional
Study Design: Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Primary Purpose: Treatment
Official Title: The Effect of Genistein (Supro®) on Coronary Artery Diameter and Blood Flow in Men and Women With Coronary Heart Disease

Resource links provided by NLM:


Further study details as provided by Imperial College London:

Primary Outcome Measures:
  • Coronary artery diameter [ Time Frame: On the day of angiography (day 3-4 after Supro/placebo started). No further follow-up. ]

Secondary Outcome Measures:
  • Coronary blood flow [ Time Frame: On the day of angiography (day 3-4 after Supro/placebo started). No further follow-up. ]

Enrollment: 26
Study Start Date: October 1999
Estimated Study Completion Date: April 2003
Arms Assigned Interventions
Experimental: Genistein
Supro drink once daily for 3 days
Drug: Genistein
Drink taken once daily
Other Name: Supro
Placebo Comparator: Placebo
Drink identical to Supro but containing no genistein, once daily for 3 days
Drug: Placebo
Drink taken once daily

  Eligibility

Information from the National Library of Medicine

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Ages Eligible for Study:   30 Years to 75 Years   (Adult, Senior)
Sexes Eligible for Study:   All
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
Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): 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

ClinicalTrials.gov Identifier: NCT00287690     History of Changes
Other Study ID Numbers: 98-170
First Submitted: February 6, 2006
First Posted: February 7, 2006
Last Update Posted: October 22, 2015
Last Verified: February 2006

Keywords provided by Imperial College London:
arteries
blood flow
coronary artery disease
diet

Additional relevant MeSH terms:
Coronary Artery Disease
Myocardial Ischemia
Coronary Disease
Heart Diseases
Cardiovascular Diseases
Arteriosclerosis
Arterial Occlusive Diseases
Vascular Diseases
Genistein
Anticarcinogenic Agents
Protective Agents
Physiological Effects of Drugs
Antineoplastic Agents
Protein Kinase Inhibitors
Enzyme Inhibitors
Molecular Mechanisms of Pharmacological Action
Phytoestrogens
Estrogens, Non-Steroidal
Estrogens
Hormones
Hormones, Hormone Substitutes, and Hormone Antagonists