Trial · NCT00287690
Isoflavones and the Coronary Circulation in Men and Women With Coronary Artery Disease
NCT00287690, Phase 2, Phase 3, Completed, Imperial College London; results first posted 2019-08-05
3 sourcestrials-2026-11-12-0.5.0
Cite this record
ConductScience Library. Isoflavones and the Coronary Circulation in Men and Women With Coronary Artery Disease. Trials, record NCT00287690. Release trials-2026-11-12-0.5.0, 12 Nov 2026. https://conductscience.org/library/trials/NCT00287690
On this page
Trial
As registered on ClinicalTrials.gov, in the graph's capture of the registry.
- Title
- Isoflavones and the Coronary Circulation in Men and Women With Coronary Artery Disease
- NCT number
- NCT00287690
- Status
- Completed
- Phases
- Phase 2, Phase 3
- Enrollment
- 71 participants, actual
- Lead sponsor
- Imperial College London
- Conditions
- Coronary Artery Disease
- Interventions
- Genistein, Placebo
- First posted
- 2006-02-07
- Last updated
- 2019-08-05
- Results first posted
- 2019-08-05
Source ClinicalTrials.gov
Registered outcomes3
Each outcome the trial registered, primary first, in ClinicalTrials.gov's words.
| List | Outcome | Time frame | Description |
|---|---|---|---|
| Primary | Coronary Artery Diameter | 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). |
| Primary | Coronary Blood Flow | 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 | Serum Genistein Concentrations | Day 3 after Supro/placebo started. | Measured from serum using liquid-chromatographic tandem mass spectrometric bioanalytical assays (HFL Ltd, Fordham, Cambridgeshire, UK). |
Source ClinicalTrials.gov
Outcomes3
Each outcome the trial posted results for, in ClinicalTrials.gov's words.
| Type | Outcome | Time frame | Population | Units | Measured as |
|---|---|---|---|---|---|
| PRIMARY | Coronary Artery Diameter | Day 3-4 after Supro/placebo started. | mm | MEAN | |
| PRIMARY | Coronary Blood Flow | Day 3-4 after Supro/placebo started. | ml/min | MEAN | |
| SECONDARY | Serum Genistein Concentrations | Day 3 after Supro/placebo started. | ng/ml | MEDIAN |
Source ClinicalTrials.gov
Results by group6
Each measurement the trial posted, group by group, in the words and numbers it posted.
| Outcome | Group | Category | Value | Spread | Units |
|---|---|---|---|---|---|
| Coronary Artery Diameter | Genistein | 3.1 | Standard Deviation 0.4 | mm | |
| Coronary Artery Diameter | Placebo | 2.7 | Standard Deviation 0.4 | mm | |
| Coronary Blood Flow | Genistein | 77 | Standard Deviation 34 | ml/min | |
| Coronary Blood Flow | Placebo | 68 | Standard Deviation 32 | ml/min | |
| Serum Genistein Concentrations | Genistein | 340 | 95% Confidence Interval 247 to 515 | ng/ml | |
| Serum Genistein Concentrations | Placebo | 3.9 | 95% Confidence Interval 1.7 to 5.8 | ng/ml |
Source ClinicalTrials.gov
Participant flow6
How many started, completed or left each group, period by period.
| Period | Milestone | Group | Participants | Units counted |
|---|---|---|---|---|
| Overall Study | STARTED | Genistein | 33 | |
| Overall Study | STARTED | Placebo | 38 | |
| Overall Study | COMPLETED | Genistein | 13 | |
| Overall Study | COMPLETED | Placebo | 12 | |
| Overall Study | NOT COMPLETED | Genistein | 20 | |
| Overall Study | NOT COMPLETED | Placebo | 26 |
Source ClinicalTrials.gov
Adverse events0
Each adverse event the trial posted, group by group: the participants affected out of those at risk.
None in this release.
Adverse event totals6
The totals the trial posted for each group.
| Total | Group | Affected | At risk |
|---|---|---|---|
| Total, all-cause mortality | Genistein | 0 | 13 |
| Total, all-cause mortality | Placebo | 0 | 12 |
| Total, other adverse events | Genistein | 0 | 13 |
| Total, other adverse events | Placebo | 0 | 12 |
| Total, serious adverse events | Genistein | 0 | 13 |
| Total, serious adverse events | Placebo | 0 | 12 |
Source ClinicalTrials.gov
Papers0
The papers the trial lists on ClinicalTrials.gov.
None in this release.
Grants0
The grants NIH RePORTER links to the trial, newest funded first: NIH's, and some of AHRQ's, CDC's, FDA's and VA's. Each shows its title, principal investigators, organization and funder in its newest year.
None in this release.
Trial comparisons2
Comparisons of the trial's two groups, calculated by ConductScience from the counts it posted.
| Comparison | Source |
|---|---|
| Genistein vs Placebo: deaths from any cause | Trial comparisons |
| Genistein vs Placebo: serious adverse events | Trial comparisons |
Tests0
The ConductCognition tests this trial's registered outcomes name, as ScienceGraph matched them in trial-tests-2026-11-12-0.2.1.
None in this release.
Data dates
The day each source was copied for this release.
Sources 3
- ClinicalTrials.gov's posted results, through CTTI's AACTFreely available. Acknowledgement requested
- ClinicalTrials.govNo license stated
- NIH RePORTER's clinical studies and project filesPublic domain
Each source's terms
- ClinicalTrials.gov's posted results, through CTTI's AACTClinicalTrials.gov data via Aggregate Analysis of ClinicalTrials.gov (AACT), CTTI. CTTI makes its materials freely available and requests acknowledgement. https://aact.ctti-clinicaltrials.org/documentation/299
- ClinicalTrials.govnone stated
- NIH RePORTER's clinical studies and project filesPublic domain (NIH RePORTER)
ClinicalTrials.gov's data carry an international copyright outside the United States: https://clinicaltrials.gov/about-site/terms-conditions.
For software
Read this trial from software.
The record and each of its lists are JSON, twenty rows a page. No key.
GET https://conductscience.org/api/trials/v1/NCT00287690
GET https://conductscience.org/api/trials/v1/NCT00287690/registered