Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
To assess prognostic value of CCTA examination in subjects who undergo CCTA as part of their medical care when compared to a standard of truth, i.e. subject outcomes during each follow-up period.
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
| Measure | Description | Time Frame |
|---|---|---|
| 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). | 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. | Within 1 month, 6 months and 12 months post contrast administration. |
| 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). | 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. | Within 1 month, 6 months and 12 months post contrast administration. |
| 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). | 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. | Within 1 month, 6 months and 12 months post contrast administration. |
| 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). | 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. |
| Measure | Description | Time Frame |
|---|---|---|
| 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. | 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. |
Not provided
Inclusion Criteria:
Not provided
Not provided
Not provided
Patient suspected of having coronary artery disease or CAD.
Not provided
| Name | Affiliation | Role |
|---|---|---|
| Rubin Sheng, M.D. | GE Healthcare | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| GE Healthcare | Princeton | New Jersey | 08540 | United States |
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.
Not provided
Not provided
| ID | Title | Description |
|---|---|---|
| FG000 | Arm 1: Visipaque Injection x 320mgI/mL | Injection of Visipaque at a concentration of 320mg I /mL. |
| Title | Milestones | Reasons Not Completed | ||||||||||||||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Overall Study |
|
|
Not provided
Not provided
| ID | Title | Description |
|---|---|---|
| BG000 | Arm 1: Visipaque Injection x 320mgI/mL | Injection of Visipaque at a concentration of 320mg I /mL. |
| Units | Counts |
|---|---|
| Participants |
|
| Title | Description | Population Description | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Denominator Units Selected | Denominators | Classes |
|---|---|---|---|---|---|---|---|---|---|
| Age, Continuous | Mean |
| Type | Title | Description | Population Description | Reporting Status | Anticipated Posting Date | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Time Frame | Units Analyzed | Denominator Units Selected | Arm/Group Information | Denominators | Classes | Analyses | |||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Primary | 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). | 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. | The subject follow-up period went from 1 month, 6 months and 12 months. | Posted | Number | 95% Confidence Interval | Percentage of Subjects | Within 1 month, 6 months and 12 months post contrast administration. |
|
Not provided
Adverse event collection were taken from 874 subjects coming from the safety population of this study.
Not provided
| ID | Title | Description | Deaths (Affected) | Deaths (At Risk) | Serious Events (Affected) | Serious Events (At Risk) | Other Events (Affected) | Other Events (At Risk) |
|---|---|---|---|---|---|---|---|---|
| EG000 | Arm 1: Visipaque Injection x 320mgI/mL | Injection of Visipaque at a concentration of 320mg I /mL. |
| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Angina Pectoris | Cardiac disorders | 11.0 | Systematic Assessment |
Not provided
Not provided
| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| Paul Gordon, PhD | GE Healthcare | 011-47-2318-5822 | paul.gordon@ge.com |
Not provided
| ID | Term |
|---|---|
| D003324 | Coronary Artery Disease |
| ID | Term |
|---|---|
| D003327 | Coronary Disease |
| D017202 | Myocardial Ischemia |
| D006331 | Heart Diseases |
| D002318 | Cardiovascular Diseases |
Not provided
Not provided
Not provided
Not provided
Not provided
| Within 1 month, 6 months and 12 months post contrast administration. |
| Within 1 month, 6 months and 12 months post contrast administration. |
| Physician Decision |
|
| Withdrawal by Subject |
|
| years |
|
| Age, Categorical | Count of Participants | Participants |
|
| Sex: Female, Male | Count of Participants | Participants |
|
| Region of Enrollment | Number | participants |
|
| OG001 | Sensitivity - Subject Follow-up Period 6 Months | Number of Subjects Positive by Coronary Computed Tomography Angiography (CCTA) & Standard of Truth (SoT) / # Subjects Negative by Standard of Truth (SoT). |
| OG002 | Sensitivity - Subject Follow-up Period 12 Months | Number of Subjects Positive by Coronary Computed Tomography Angiography (CCTA) & Standard of Truth (SoT) / # Subjects Negative by Standard of Truth (SoT). |
|
|
| Primary | 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). | 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. | Posted | Number | 95% Confidence Interval | Percentage of Subjects | Within 1 month, 6 months and 12 months post contrast administration. |
|
|
|
| Primary | 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). | 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. | Posted | Number | 95% Confidence Interval | Percentage of Subjects | Within 1 month, 6 months and 12 months post contrast administration. |
|
|
|
| Primary | 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). | 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. | Posted | Number | 95% Confidence Interval | Percentage of Subjects | Within 1 month, 6 months and 12 months post contrast administration. |
|
|
|
| Secondary | 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. | 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. | Posted | Number | Number of Subjects | Within 1 month, 6 months and 12 months post contrast administration. |
|
|
|
| 8 |
| 874 |
| 0 |
| 874 |
| Coronary Artery Disease | Cardiac disorders | 11.0 | Systematic Assessment |
|
| Coronary Artery Stenosis | Cardiac disorders | 11.0 | Systematic Assessment |
|
| Non-Cardiac Chest Pain | General disorders | 11.0 | Systematic Assessment |
|
| Pulmonary Embolism | Respiratory, thoracic and mediastinal disorders | 11.0 | Systematic Assessment |
|
| Aortic Aneurysm | Vascular disorders | 11.0 | Systematic Assessment |
|
Not provided
Not provided
| D001161 |
| Arteriosclerosis |
| D001157 | Arterial Occlusive Diseases |
| D014652 | Vascular Diseases |
|