Trial Outcomes & Findings for Study in Subjects Suspected of Having CAD Undergoing VISIPAQUE-enhanced CCTA as Part of Their Routine Medical Care (NCT NCT00783302)
NCT ID: NCT00783302
Last Updated: 2014-12-11
Results Overview
Statistical analysis of the Sensitivity of Visipaque-enhanced CCTA for predicting downstream cardiovascular events at each follow-up period when compared to the SoT. The results are calculated as percentage of participants.
COMPLETED
885 participants
Within 1 month, 6 months and 12 months post contrast administration.
2014-12-11
Participant Flow
885 subjects enrolled in the Study. 874 subjects are in the safety population where adverse event data was collected, 857 subjects are in the efficacy population. 850 subjects completed the study. 35 subjects discontinued the study.
Participant milestones
| Measure |
Arm 1: Visipaque Injection x 320mgI/mL
Injection of Visipaque at a concentration of 320mg I /mL.
|
|---|---|
|
Overall Study
STARTED
|
885
|
|
Overall Study
COMPLETED
|
850
|
|
Overall Study
NOT COMPLETED
|
35
|
Reasons for withdrawal
| Measure |
Arm 1: Visipaque Injection x 320mgI/mL
Injection of Visipaque at a concentration of 320mg I /mL.
|
|---|---|
|
Overall Study
Lost to Follow-up
|
17
|
|
Overall Study
Technical Problems
|
11
|
|
Overall Study
Protocol Violation
|
3
|
|
Overall Study
Physician Decision
|
1
|
|
Overall Study
Withdrawal by Subject
|
3
|
Baseline Characteristics
Study in Subjects Suspected of Having CAD Undergoing VISIPAQUE-enhanced CCTA as Part of Their Routine Medical Care
Baseline characteristics by cohort
| Measure |
Arm 1: Visipaque Injection x 320mgI/mL
n=874 Participants
Injection of Visipaque at a concentration of 320mg I /mL.
|
|---|---|
|
Age, Continuous
|
58.8 years
STANDARD_DEVIATION 11.96 • n=5 Participants
|
|
Age, Categorical
<=18 years
|
0 Participants
n=5 Participants
|
|
Age, Categorical
Between 18 and 65 years
|
568 Participants
n=5 Participants
|
|
Age, Categorical
>=65 years
|
306 Participants
n=5 Participants
|
|
Sex: Female, Male
Female
|
431 Participants
n=5 Participants
|
|
Sex: Female, Male
Male
|
443 Participants
n=5 Participants
|
|
Region of Enrollment
United States
|
736 participants
n=5 Participants
|
|
Region of Enrollment
Canada
|
138 participants
n=5 Participants
|
PRIMARY outcome
Timeframe: Within 1 month, 6 months and 12 months post contrast administration.Population: The subject follow-up period went from 1 month, 6 months and 12 months.
Statistical analysis of the Sensitivity of Visipaque-enhanced CCTA for predicting downstream cardiovascular events at each follow-up period when compared to the SoT. The results are calculated as percentage of participants.
Outcome measures
| Measure |
Sensitivity - Subject Follow-up Period 1 Month
n=51 Participants
Number of Subjects Positive by Coronary Computed Tomography Angiography (CCTA) \& Standard of Truth (SoT) / # Subjects Negative by Standard of Truth (SoT).
|
Sensitivity - Subject Follow-up Period 6 Months
n=71 Participants
Number of Subjects Positive by Coronary Computed Tomography Angiography (CCTA) \& Standard of Truth (SoT) / # Subjects Negative by Standard of Truth (SoT).
|
Sensitivity - Subject Follow-up Period 12 Months
n=76 Participants
Number of Subjects Positive by Coronary Computed Tomography Angiography (CCTA) \& Standard of Truth (SoT) / # Subjects Negative by Standard of Truth (SoT).
|
|---|---|---|---|
|
The Sensitivity of Visipaque-enhanced Coronary Computed Tomography Angiography (CCTA) for Predicting Downstream Cardiovascular Events at Each Follow-up Period When Compared to the Standard of Truth (SoT).
|
96.1 Percentage of Subjects
Interval 86.5 to 99.5
|
95.8 Percentage of Subjects
Interval 88.1 to 99.1
|
94.7 Percentage of Subjects
Interval 87.1 to 98.5
|
PRIMARY outcome
Timeframe: Within 1 month, 6 months and 12 months post contrast administration.Statistical analysis of the Positive Predictive Value (PPV) of Visipaque-enhanced CCTA for predicting downstream cardiovascular events at each follow-up period when compared to the SoT.The results are calculated as percentage of participants.
Outcome measures
| Measure |
Sensitivity - Subject Follow-up Period 1 Month
n=174 Participants
Number of Subjects Positive by Coronary Computed Tomography Angiography (CCTA) \& Standard of Truth (SoT) / # Subjects Negative by Standard of Truth (SoT).
|
Sensitivity - Subject Follow-up Period 6 Months
n=173 Participants
Number of Subjects Positive by Coronary Computed Tomography Angiography (CCTA) \& Standard of Truth (SoT) / # Subjects Negative by Standard of Truth (SoT).
|
Sensitivity - Subject Follow-up Period 12 Months
n=172 Participants
Number of Subjects Positive by Coronary Computed Tomography Angiography (CCTA) \& Standard of Truth (SoT) / # Subjects Negative by Standard of Truth (SoT).
|
|---|---|---|---|
|
The Positive Predictive Value (PPV) of Visipaque-enhanced Coronary Computed Tomography Angiography (CCTA) for Ruling Out Downstream Cardiovascular Events at Each Follow-up Period When Compared to the Standard of Truth (SoT).
|
28.2 Percentage of Subjects
Interval 21.6 to 35.5
|
39.3 Percentage of Subjects
Interval 32.0 to 47.0
|
41.9 Percentage of Subjects
Interval 34.4 to 49.6
|
PRIMARY outcome
Timeframe: Within 1 month, 6 months and 12 months post contrast administration.Statistical analysis of the Specificity of Visipaque-enhanced CCTA for ruling out downstream cardiovascular events at each follow-up period when compared to the SoT.The results are calculated as percentage of participants.
Outcome measures
| Measure |
Sensitivity - Subject Follow-up Period 1 Month
n=806 Participants
Number of Subjects Positive by Coronary Computed Tomography Angiography (CCTA) \& Standard of Truth (SoT) / # Subjects Negative by Standard of Truth (SoT).
|
Sensitivity - Subject Follow-up Period 6 Months
n=782 Participants
Number of Subjects Positive by Coronary Computed Tomography Angiography (CCTA) \& Standard of Truth (SoT) / # Subjects Negative by Standard of Truth (SoT).
|
Sensitivity - Subject Follow-up Period 12 Months
n=767 Participants
Number of Subjects Positive by Coronary Computed Tomography Angiography (CCTA) \& Standard of Truth (SoT) / # Subjects Negative by Standard of Truth (SoT).
|
|---|---|---|---|
|
The Specificity of Visipaque-enhanced Coronary Computed Tomography Angiography (CCTA) for Ruling Out Downstream Cardiovascular Events at Each Follow-up Period When Compared to the Standard of Truth (SoT).
|
84.5 Percentage of Subjects
Interval 81.8 to 86.9
|
86.6 Percentage of Subjects
Interval 84.0 to 88.9
|
87.0 Percentage of Subjects
Interval 84.4 to 89.3
|
PRIMARY outcome
Timeframe: Within 1 month, 6 months and 12 months post contrast administration.Statistical analysis of the Negative Predictive Value (NPV) of Visipaque-enhanced CCTA for ruling out downstream cardiovascular events at each follow-up period when compared to the SoT.The results are calculated as percentage of participants.
Outcome measures
| Measure |
Sensitivity - Subject Follow-up Period 1 Month
n=683 Participants
Number of Subjects Positive by Coronary Computed Tomography Angiography (CCTA) \& Standard of Truth (SoT) / # Subjects Negative by Standard of Truth (SoT).
|
Sensitivity - Subject Follow-up Period 6 Months
n=680 Participants
Number of Subjects Positive by Coronary Computed Tomography Angiography (CCTA) \& Standard of Truth (SoT) / # Subjects Negative by Standard of Truth (SoT).
|
Sensitivity - Subject Follow-up Period 12 Months
n=671 Participants
Number of Subjects Positive by Coronary Computed Tomography Angiography (CCTA) \& Standard of Truth (SoT) / # Subjects Negative by Standard of Truth (SoT).
|
|---|---|---|---|
|
The Negative Predictive Value (NPV) of Visipaque-enhanced Coronary Computed Tomography Angiography (CCTA) for Ruling Out Downstream Cardiovascular Events at Each Follow-up Period When Compared to the Standard of Truth (SoT).
|
99.7 Percentage of Subjects
Interval 98.9 to 100.0
|
99.6 Percentage of Subjects
Interval 98.7 to 99.9
|
99.4 Percentage of Subjects
Interval 98.5 to 99.8
|
SECONDARY outcome
Timeframe: Within 1 month, 6 months and 12 months post contrast administration.The number of subjects in the efficacy population developing 1 or more positive and negative cardiac clinical outcomes at 1 month, 6 months, and 12 months after undergoing a Coronary Computed Tomography Angiography (CCTA) examination using Visipaque. Clinical outcomes are independent of any serious adverse events and adverse events associated with the drug administration. This outcome measure is not reporting those subjects with serious adverse events and adverse events associated with the drug administration.
Outcome measures
| Measure |
Sensitivity - Subject Follow-up Period 1 Month
n=857 Participants
Number of Subjects Positive by Coronary Computed Tomography Angiography (CCTA) \& Standard of Truth (SoT) / # Subjects Negative by Standard of Truth (SoT).
|
Sensitivity - Subject Follow-up Period 6 Months
n=853 Participants
Number of Subjects Positive by Coronary Computed Tomography Angiography (CCTA) \& Standard of Truth (SoT) / # Subjects Negative by Standard of Truth (SoT).
|
Sensitivity - Subject Follow-up Period 12 Months
n=843 Participants
Number of Subjects Positive by Coronary Computed Tomography Angiography (CCTA) \& Standard of Truth (SoT) / # Subjects Negative by Standard of Truth (SoT).
|
|---|---|---|---|
|
Summary of Subjects Developing 1 or More Positive and Negative Cardiac Clinical Outcomes at 1 Month, 6 Months, and 12 Months After Undergoing Coronary Computed Tomography Angiography (CCTA) Examination Using Visipaque.
Positive Clinical Outcome
|
51 Number of Subjects
|
71 Number of Subjects
|
76 Number of Subjects
|
|
Summary of Subjects Developing 1 or More Positive and Negative Cardiac Clinical Outcomes at 1 Month, 6 Months, and 12 Months After Undergoing Coronary Computed Tomography Angiography (CCTA) Examination Using Visipaque.
Negative Clinical Outcome
|
806 Number of Subjects
|
782 Number of Subjects
|
767 Number of Subjects
|
Adverse Events
Arm 1: Visipaque Injection x 320mgI/mL
Serious adverse events
| Measure |
Arm 1: Visipaque Injection x 320mgI/mL
n=874 participants at risk
Injection of Visipaque at a concentration of 320mg I /mL.
|
|---|---|
|
Cardiac disorders
Angina Pectoris
|
0.34%
3/874 • Number of events 3
Adverse event collection were taken from 874 subjects coming from the safety population of this study.
|
|
Cardiac disorders
Coronary Artery Disease
|
0.23%
2/874 • Number of events 2
Adverse event collection were taken from 874 subjects coming from the safety population of this study.
|
|
Cardiac disorders
Coronary Artery Stenosis
|
0.11%
1/874 • Number of events 2
Adverse event collection were taken from 874 subjects coming from the safety population of this study.
|
|
General disorders
Non-Cardiac Chest Pain
|
0.11%
1/874 • Number of events 1
Adverse event collection were taken from 874 subjects coming from the safety population of this study.
|
|
Respiratory, thoracic and mediastinal disorders
Pulmonary Embolism
|
0.11%
1/874 • Number of events 1
Adverse event collection were taken from 874 subjects coming from the safety population of this study.
|
|
Vascular disorders
Aortic Aneurysm
|
0.11%
1/874 • Number of events 1
Adverse event collection were taken from 874 subjects coming from the safety population of this study.
|
Other adverse events
Adverse event data not reported
Additional Information
Results disclosure agreements
- Principal investigator is a sponsor employee
- Publication restrictions are in place