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

October 16, 2024 updated by: Insel Gruppe AG, University Hospital Bern
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.

Study Overview

Status

Recruiting

Conditions

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 Type

Observational

Enrollment (Estimated)

4200

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

Study Locations

  • Switzerland
      • Bern, Switzerland, 3010
        • Recruiting
        • Department of Cardiology, University Hospital Bern, Inselspital, Bern
        • Contact:

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years and older (Adult, Older Adult)

Accepts Healthy Volunteers

No

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.

Description

Inclusion Criteria:

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

Exclusion Criteria:

  • None

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

Cohorts and Interventions

Group / Cohort
Patients undergoing clinically indicated CCTA

What is the study measuring?

Primary Outcome Measures

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

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Major adverse cardiovascular events (MACE)
Time Frame: 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)
10 years
Other outcome
Time Frame: 10 years

Occurrence of any of the following events:

  1. Cerebrovascular accident
  2. Valvular intervention
  3. Congestive heart failure-related hospitalization
  4. Cardiac death
10 years

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Insel Gruppe AG, University Hospital Bern

Collaborators

University Hospital, Zürich

Investigators

  • Principal Investigator: Christoph Gräni, MD, PhD, Department of Cardiology, University Hospital Bern,

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

June 1, 2017

Primary Completion (Estimated)

February 1, 2031

Study Completion (Estimated)

February 1, 2031

Study Registration Dates

First Submitted

March 29, 2021

First Submitted That Met QC Criteria

March 29, 2021

First Posted (Actual)

April 1, 2021

Study Record Updates

Last Update Posted (Actual)

October 18, 2024

Last Update Submitted That Met QC Criteria

October 16, 2024

Last Verified

October 1, 2024

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • 2021-00058

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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