Clinical Utility and Outcome Prediction of Cardiovascular Computed Tomography (PREDICT-CT)
Study Details
Study Description
Brief Summary
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.
| Condition or Disease | Intervention/Treatment | Phase |
|---|---|---|
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Detailed Description
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.
Study Design
Arms and Interventions
| Arm | Intervention/Treatment |
|---|---|
| Patients undergoing clinically indicated CCTA Patients undergoing clinically indicated CCTA |
Outcome Measures
Primary Outcome Measures
- All-cause death. [10 years]
The primary endpoint is the time to first occurrence of death from all-causes.
Secondary Outcome Measures
- Major adverse cardiovascular events (MACE) [10 years]
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)
- Other outcome [10 years]
Occurrence of any of the following events: Cerebrovascular accident Valvular intervention Congestive heart failure-related hospitalization Cardiac death
Eligibility Criteria
Criteria
Inclusion Criteria:
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Adult individual >18 years
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Undergoing clinically indicated CCTA
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Signed informed consent or waiver
Exclusion Criteria:
- None
Contacts and Locations
Locations
| Site | City | State | Country | Postal Code | |
|---|---|---|---|---|---|
| 1 | Department of Cardiology, University Hospital Bern, Inselspital, Bern | Bern | Switzerland | 3010 |
Sponsors and Collaborators
- University Hospital Inselspital, Berne
Investigators
- Principal Investigator: Christoph Gräni, MD, PhD, Department of Cardiology, University Hospital Bern,
Study Documents (Full-Text)
None provided.More Information
Publications
None provided.- 2021-00058