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

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.
 
ClinicalTrials.gov Identifier: NCT00287690
Recruitment Status : Completed
First Posted : February 7, 2006
Results First Posted : August 5, 2019
Last Update Posted : August 5, 2019
Sponsor:
Information provided by (Responsible Party):
Imperial College London

Study Description
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Brief 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).

Condition or disease Intervention/treatment Phase
Coronary Artery Disease Drug: Genistein Drug: Placebo Phase 2 Phase 3

Study Design
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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 71 participants
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
Study Start Date : October 1999
Actual Primary Completion Date : August 18, 2003
Actual Study Completion Date : August 18, 2003

Resource links provided by the National Library of Medicine

Drug Information available for: Genistein

Arms and Interventions
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Arm Intervention/treatment
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


Outcome Measures
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Primary Outcome Measures :
  1. Coronary Artery Diameter [ Time Frame: Day 3-4 after Supro/placebo started. ]
    Coronary angiograms were acquired digitally using a real-time digital image acquisition system (Siemens AG, Berlin and Munich, Germany) and analysed off-line using quantitative coronary angiography (MEDIS, Leiden, The Netherlands). Basal luminal diameter of the entire coronary artery (mean luminal diameter) was measured for all subjects. Mean luminal diameter and luminal diameter approximately 4 mm distal to the tip of the Doppler wire were measured. The latter measurements were used to quantify volume flow as described previously. Data below are mean coronary artery diameter response following infusion of acetylcholine (ACh 10-5 M).

  2. Coronary Blood Flow [ Time Frame: Day 3-4 after Supro/placebo started. ]
    Measurement of diameter 4mm distal to the Doppler wire tip (measured using quantitative coronary angiography) and blood flow velocity, measured using intracoronary Doppler), were made at baseline and at peak velocity change. A quantitative estimate of coronary blood flow was calculated from the Doppler flow velocity and quantitative angiographic data using the following equation: Q = 3.14(D2/4)(APV/2)(0.6) where Q is flow (ml/min), D is vessel diameter (mm) and APV is average peak velocity (cm/s). Data below are measurements taken at peak blood flow response following an infusion of acetylcholine (10-5M).


Secondary Outcome Measures :
  1. Serum Genistein Concentrations [ Time Frame: Day 3 after Supro/placebo started. ]
    Measured from serum using liquid-chromatographic tandem mass spectrometric bioanalytical assays (HFL Ltd, Fordham, Cambridgeshire, UK).


Eligibility Criteria
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Ages Eligible for Study:   30 Years to 75 Years   (Adult, Older Adult)
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
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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
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United Kingdom
Royal Brompton & Harefield NHS Trust
London, United Kingdom, SW3 6NP
Sponsors and Collaborators
Imperial College London
Investigators
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Principal Investigator: Peter Collins, MD, FRCP Imperial College London
More Information
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Responsible Party: Imperial College London
ClinicalTrials.gov Identifier: NCT00287690    
Other Study ID Numbers: 98-170
First Posted: February 7, 2006    Key Record Dates
Results First Posted: August 5, 2019
Last Update Posted: August 5, 2019
Last Verified: February 2006
Keywords provided by Imperial College London:
arteries
blood flow
coronary artery disease
diet
Additional relevant MeSH terms:
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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