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

Coronary Artery Disease Clinical Trial

— PREDICT-CT  

Official title:

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

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT04827316
• Other study ID #: 2021-00058
• Status: Recruiting
• Start date: June 1, 2017
• Est. completion date: February 1, 2031

Study information

• Verified date: July 2023
• Source: Insel Gruppe AG, University Hospital Bern
• Contact: Christoph Gräni, MD, PHD
• Phone: +41 31 632 4508
• Email: christoph.graeni[@]insel.ch
• Is FDA regulated: No
• Study type: Observational [Patient Registry]

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 4200
• Est. completion date: February 1, 2031
• Est. primary completion date: February 1, 2031
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

Inclusion Criteria:

• Adult individual >18 years

• Undergoing clinically indicated CCTA

• Signed informed consent or waiver

Exclusion Criteria:

• None

Related Conditions & MeSH terms

• Arteriosclerosis
• Coronary Arteriosclerosis
• Coronary Artery Disease
• Coronary; Ischemic
• Myocardial Ischemia

Locations

Country	Name	City	State
Switzerland	Department of Cardiology, University Hospital Bern, Inselspital, Bern	Bern

Sponsors (1)

Lead Sponsor	Collaborator
Insel Gruppe AG, University Hospital Bern

Country where clinical trial is conducted

Switzerland, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	All-cause death.	The primary endpoint is the time to first occurrence of death from all-causes.	10 years
Secondary	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
Secondary	Other outcome	Occurrence of any of the following events: Cerebrovascular accident; Valvular intervention; Congestive heart failure-related hospitalization; Cardiac death	10 years