Clinical Utility and Outcome Prediction of Cardiovascular Computed Tomography (PREDICT-CT)

Study Overview
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Brief Summary
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In this study the investigators retrospectively and prospectively collect information from enrolled subjects undergoing CCTA and evaluate the association of cardiac and non-cardiac imaging with laboratory markers and clinical data including outcome.

Detailed Description
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In this study the investigators retrospectively and prospectively collect information from enrolled subjects through a period of a total of 10 years to evaluate multidimensional associations between phenotypic manifestations of cardiovascular disease via CCTA and cardiac and non-cardiac imaging, serum biomarkers, demographic and clinical information, clinical presentation (cross-sectional), therapy changes (time-varying) and their ability to predict mortality and MACE (major adverse cardiac event ) (longitudinal) in patients clinically indicated for CCTA. The aim is to establish a comprehensive cross-sectional, time-varying and longitudinal data collection for individuals undergoing clinically-indicated CCTA to date in order to apply novel multiparametric approaches to determine cardiovascular significance to clinically-important patient-centered events. For data collection this registry will follow a standard CRF (case report form) structure, so to enable the merging of this data-set with other international registries, which might contribute in overcoming some gaps of knowledge from previous CCTA studies.

Official Title
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Clinical Utility and Outcome Prediction of Cardiovascular Computed Tomography (PREDICT-CT)

Conditions
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Coronary Artery Disease, Coronary Arteriosclerosis, Coronary; Ischemic

Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: Adult individual >18 years Undergoing clinically indicated CCTA Signed informed consent or waiver Exclusion Criteria: None

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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Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Patients undergoing clinically indicated CCTA<br>Patients undergoing clinically indicated CCTA | |

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| All-cause death. | The primary endpoint is the time to first occurrence of death from all-causes. | 10 years | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Major adverse cardiovascular events (MACE) | The secondary composite endpoint is major adverse cardiac events (MACE), which is defined by the occurrence of any of the following events: All-cause death Myocardial infarction Unstable angina-related hospitalization Late coronary revascularization (≥90 days) | 10 years | 
| Other outcome | Occurrence of any of the following events: Cerebrovascular accident Valvular intervention Congestive heart failure-related hospitalization Cardiac death | 10 years | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Cardiovascular Computed Tomography