Clinical trial NCT04827316: Clinical Utility and Outcome Prediction of Cardiovascular Computed Tomography (PREDICT-CT)
Official title: Clinical Utility and Outcome Prediction of Cardiovascular Computed Tomography (PREDICT-CT)
Study type: OBSERVATIONAL
Overall status: RECRUITING
Conditions: Coronary Artery Disease
Coronary Arteriosclerosis
Coronary; Ischemic
Keywords: Cardiovascular Computed Tomography
Lead sponsor: Insel Gruppe AG, University Hospital Bern
Sponsor class: OTHER
Collaborators: name: University Hospital, Zürich
First posted: 2021-04-01
Enrollment: 4200
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: COHORT
Time perspective: PROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: The registry foreseen a prospective cohort composed by patients undergoing clinically indicated CCTA and by a retrospective population of patients that have undergone CCTA 1st June 2017 to 31st December 2020. The principal investigator confirms that no patient's personal health data will be collected if a written or documented oral refusal exist.

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.

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.

Eligibility criteria: Inclusion Criteria:

* Adult individual \>18 years
* Undergoing clinically indicated CCTA
* Signed informed consent or waiver

Exclusion Criteria:

* None

Primary outcomes:
measure: All-cause death.
timeFrame: 10 years
Secondary outcomes:
measure: Major adverse cardiovascular events (MACE)
timeFrame: 10 years
measure: Other outcome
timeFrame: 10 years
Other outcomes:
Locations:
city: Bern
country: Switzerland
facility: Department of Cardiology, University Hospital Bern, Inselspital, Bern
Study officials:
affiliation: Department of Cardiology, University Hospital Bern,
name: Christoph Gräni, MD, PhD
role: PRINCIPAL_INVESTIGATOR
References: