Isoflavones and the Coronary Circulation in Men and Women With Coronary Artery Disease
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|ClinicalTrials.gov Identifier: NCT00287690|
Recruitment Status : Completed
First Posted : February 7, 2006
Results First Posted : August 5, 2019
Last Update Posted : August 5, 2019
|Condition or disease||Intervention/treatment||Phase|
|Coronary Artery Disease||Drug: Genistein Drug: Placebo||Phase 2 Phase 3|
|Study Type :||Interventional (Clinical Trial)|
|Actual Enrollment :||71 participants|
|Intervention Model:||Parallel Assignment|
|Masking:||Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)|
|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|
Supro drink once daily for 3 days
Drink taken once daily
Other Name: Supro
Placebo Comparator: Placebo
Drink identical to Supro but containing no genistein, once daily for 3 days
Drink taken once daily
- 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).
- 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).
- 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).
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
|Royal Brompton & Harefield NHS Trust|
|London, United Kingdom, SW3 6NP|
|Principal Investigator:||Peter Collins, MD, FRCP||Imperial College London|