Trial Outcomes & Findings for Isoflavones and the Coronary Circulation in Men and Women With Coronary Artery Disease (NCT NCT00287690)
NCT ID: NCT00287690
Last Updated: 2019-08-05
Results Overview
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).
COMPLETED
PHASE2/PHASE3
71 participants
Day 3-4 after Supro/placebo started.
2019-08-05
Participant Flow
Participant milestones
| Measure |
Genistein
Supro drink once daily for 3 days prior to coronary angiography
Genistein: Drink taken once daily
|
Placebo
Drink identical to Supro but containing no genistein, once daily for 3 days prior to coronary angiography.
Placebo: Drink taken once daily
|
|---|---|---|
|
Overall Study
STARTED
|
33
|
38
|
|
Overall Study
COMPLETED
|
13
|
12
|
|
Overall Study
NOT COMPLETED
|
20
|
26
|
Reasons for withdrawal
| Measure |
Genistein
Supro drink once daily for 3 days prior to coronary angiography
Genistein: Drink taken once daily
|
Placebo
Drink identical to Supro but containing no genistein, once daily for 3 days prior to coronary angiography.
Placebo: Drink taken once daily
|
|---|---|---|
|
Overall Study
Protocol Violation
|
20
|
26
|
Baseline Characteristics
Race and Ethnicity were not collected from any participant.
Baseline characteristics by cohort
| Measure |
Genistein
n=13 Participants
Supro drink once daily for 3 days
Genistein: Drink taken once daily
|
Placebo
n=12 Participants
Drink identical to Supro but containing no genistein, once daily for 3 days
Placebo: Drink taken once daily
|
Total
n=25 Participants
Total of all reporting groups
|
|---|---|---|---|
|
Age, Categorical
<=18 years
|
0 Participants
n=13 Participants
|
0 Participants
n=12 Participants
|
0 Participants
n=25 Participants
|
|
Age, Categorical
Between 18 and 65 years
|
13 Participants
n=13 Participants
|
9 Participants
n=12 Participants
|
22 Participants
n=25 Participants
|
|
Age, Categorical
>=65 years
|
0 Participants
n=13 Participants
|
3 Participants
n=12 Participants
|
3 Participants
n=25 Participants
|
|
Sex: Female, Male
Female
|
0 Participants
n=13 Participants
|
3 Participants
n=12 Participants
|
3 Participants
n=25 Participants
|
|
Sex: Female, Male
Male
|
13 Participants
n=13 Participants
|
9 Participants
n=12 Participants
|
22 Participants
n=25 Participants
|
|
Race and Ethnicity Not Collected
|
—
|
—
|
0 Participants
Race and Ethnicity were not collected from any participant.
|
|
Region of Enrollment
United Kingdom
|
13 participants
n=13 Participants
|
12 participants
n=12 Participants
|
25 participants
n=25 Participants
|
PRIMARY outcome
Timeframe: 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).
Outcome measures
| Measure |
Genistein
n=13 Participants
Supro drink once daily for 3 days prior to coronary angiography
Genistein: Drink taken once daily
|
Placebo
n=12 Participants
Drink identical to Supro but containing no genistein, once daily for 3 days prior to coronary angiography.
Placebo: Drink taken once daily
|
|---|---|---|
|
Coronary Artery Diameter
|
3.1 mm
Standard Deviation 0.4
|
2.7 mm
Standard Deviation 0.4
|
PRIMARY outcome
Timeframe: 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).
Outcome measures
| Measure |
Genistein
n=13 Participants
Supro drink once daily for 3 days prior to coronary angiography
Genistein: Drink taken once daily
|
Placebo
n=12 Participants
Drink identical to Supro but containing no genistein, once daily for 3 days prior to coronary angiography.
Placebo: Drink taken once daily
|
|---|---|---|
|
Coronary Blood Flow
|
77 ml/min
Standard Deviation 34
|
68 ml/min
Standard Deviation 32
|
SECONDARY outcome
Timeframe: Day 3 after Supro/placebo started.Measured from serum using liquid-chromatographic tandem mass spectrometric bioanalytical assays (HFL Ltd, Fordham, Cambridgeshire, UK).
Outcome measures
| Measure |
Genistein
n=13 Participants
Supro drink once daily for 3 days prior to coronary angiography
Genistein: Drink taken once daily
|
Placebo
n=12 Participants
Drink identical to Supro but containing no genistein, once daily for 3 days prior to coronary angiography.
Placebo: Drink taken once daily
|
|---|---|---|
|
Serum Genistein Concentrations
|
340 ng/ml
Interval 247.0 to 515.0
|
3.9 ng/ml
Interval 1.7 to 5.8
|
Adverse Events
Genistein
Placebo
Serious adverse events
Adverse event data not reported
Other adverse events
Adverse event data not reported
Additional Information
Results disclosure agreements
- Principal investigator is a sponsor employee
- Publication restrictions are in place