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

Status

Recruiting

Phases

Unknown

Study type

Observational

Source

ClinicalTrials.gov

Registry ID

NCT04827316

Acronym

PREDICT-CT

Enrollment

4200

Registered

2021-04-01

Start date

2017-06-01

Completion date

2031-02-01

Last updated

2024-10-18

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Coronary Arteriosclerosis, Coronary Artery Disease, Coronary; Ischemic

Keywords

Cardiovascular Computed Tomography

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.

Interventions

None listed

Study design

Observational model

COHORT

Time perspective

PROSPECTIVE

Eligibility

Sex/Gender

ALL

Age

18 Years to No maximum

Healthy volunteers

Inclusion criteria

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

Exclusion criteria

* None

Design outcomes

Primary

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

Secondary

Measure	Time frame	Description
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)
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

Countries

Switzerland

Contacts

Primary ContactChristoph Gräni, MD, PHD

christoph.graeni@insel.ch+41 31 632 4508

Outcome results