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NCT Number: NCT04827316

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

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.

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Key information

Conditions

Coronary Artery Disease Arterial Occlusive Diseases Arteriosclerosis Cardiovascular Diseases Coronary Arteriosclerosis Coronary Disease Coronary; Ischemic Heart Diseases Ischemia Myocardial Ischemia Pathologic Processes Pathological Conditions, Signs and Symptoms Vascular Diseases

Age range

18 year and older

Sex eligibility

All sexes

Study type

Observational

Primary location

Department of Cardiology, University Hospital Bern, Inselspital, Bern

Bern, 3010, Switzerland

Location status: Recruiting

Location contact

Christoph Gräni, Prof

CONTACT

[email protected]

+41316324508

About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

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

Exclusion criteria

  • None

Treatment and study plan

Primary outcomes

  1. All-cause death.

    Time frame: 10 years

    The primary endpoint is the time to first occurrence of death from all-causes.

Secondary outcomes

  1. 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:

    • All-cause death
    • Myocardial infarction
    • Unstable angina-related hospitalization
    • Late coronary revascularization (≥90 days)

  2. Other outcome

    Time frame: 10 years

    Occurrence of any of the following events:

    • Cerebrovascular accident
    • Valvular intervention
    • Congestive heart failure-related hospitalization
    • Cardiac death

Study contacts

Contact information is provided by the study sponsor or research team.

Christoph Gräni, MD, PHD

CONTACT

[email protected]

+41 31 632 4508

Sponsors and collaborators

Lead sponsor

Insel Gruppe AG, University Hospital Bern

Other

Collaborators

  • University Hospital, Zürich

Registry information

Acronym: PREDICT-CT

Important dates

Study start
2017
Primary completion
2031
Study completion
2031
First posted
Apr 1, 2021
Registry last updated
Oct 18, 2024

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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