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

Recruiting

• Conditions: Coronary Arteriosclerosis; Coronary; Ischemic; Coronary Artery Disease

• Registration Number: NCT04827316
• Lead Sponsor: Insel Gruppe AG, University Hospital Bern

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.

Study Timeline

• Study Start: 2017-06-01
• Study First Submitted: 2021-03-29
• Study First Submitted QC: 2021-03-29
• Study First Posted: 2021-04-01
• Status Verified: 2024-10
• Last Update Submitted: 2024-10-16
• Last Update Posted: 2024-10-18
• Primary Completion: 2031-02-01
• Study Completion: 2031-02-01

Recruitment & Eligibility

• Status: RECRUITING
• Sex: All
• Target Recruitment: 4200

Inclusion Criteria

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

Exclusion Criteria

• None

Study & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
All-cause death.	10 years	The primary endpoint is the time to first occurrence of death from all-causes.

Secondary Outcome Measures

Name	Time	Method
Other outcome	10 years	Occurrence of any of the following events: 1. Cerebrovascular accident; 2. Valvular intervention; 3. Congestive heart failure-related hospitalization; 4. Cardiac death
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: 1. All-cause death; 2. Myocardial infarction; 3. Unstable angina-related hospitalization; 4. Late coronary revascularization (≥90 days)

Trial Locations

Locations (1)

Department of Cardiology, University Hospital Bern, Inselspital, Bern; 🇨🇭 Bern, Switzerland