Study in Subjects Suspected of Having CAD Undergoing VISIPAQUE-enhanced CCTA as Part of Their Routine Medical Care

Study Overview
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Brief Summary
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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.

Official Title
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A Prospective, Multi-Center Registry Study for Clinical Outcome in Subjects Undergoing Coronary Computed Tomography Angiography (CCTA) Examination (VISIPAQUE Registry Study)

Conditions
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Coronary Artery Disease (CAD)

Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: The subject is over 18 years old, exhibits chest pain syndrome and is scheduled to undergo a VISIPAQUE-enhanced CCTA examination for one of the following reasons:- Intermediate pre-test probability of CAD. An uninterruptible/equivocal stress test (exercise, perfusion, or stress echo).

Ages Eligible for Study
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Minimum Age: 18 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | 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. | Within 1 month, 6 months and 12 months post contrast administration. | 

Secondary Outcome Measures

| Outcome Measure | 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. | Within 1 month, 6 months and 12 months post contrast administration. | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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CAD, Visipaque, CCTA