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

This study has been completed.
Sponsor:
Information provided by:
Imperial College London
ClinicalTrials.gov Identifier:
NCT00287690
First received: February 6, 2006
Last updated: May 23, 2006
Last verified: February 2006

February 6, 2006
May 23, 2006
October 1999
Not Provided
Coronary artery diameter
Same as current
Complete list of historical versions of study NCT00287690 on ClinicalTrials.gov Archive Site
Coronary blood flow
Same as current
Not Provided
Not Provided
 
Isoflavones and the Coronary Circulation in Men and Women With Coronary Artery Disease
The Effect of Genistein (Supro®) on Coronary Artery Diameter and Blood Flow in Men and Women With Coronary Heart Disease

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).

Not Provided
Interventional
Phase 2
Phase 3
Allocation: Randomized
Endpoint Classification: Safety Study
Intervention Model: Parallel Assignment
Masking: Double-Blind
Primary Purpose: Treatment
Coronary Artery Disease
Drug: genistein (Supro)
Not Provided
Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Completed
26
April 2003
Not Provided

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
Both
30 Years to 75 Years
No
Contact information is only displayed when the study is recruiting subjects
United Kingdom
 
NCT00287690
98-170
Not Provided
Not Provided
Imperial College London
Not Provided
Principal Investigator: Peter Collins, MD, FRCP Imperial College London
Imperial College London
February 2006

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP