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Completed

NCT Number: NCT02904239

Cardiac Pathologies in Standard Thoracic CT Imaging

Modern high-end CT scanners with faster scan acquisition times now allow for routine assessment of cardiac pathologies, which could result in numerous incidental cardiac findings on standard thoracic CT angiography (CTA) scans. The CaPaCT-study aims to assesses the presence, management and possible clinical impact of incidental cardiac pathologies which are becoming visible on standard thoracic CT scans performed on new high-end scanners.

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Key information

Conditions

Coronary Artery Disease Arterial Occlusive Diseases Arteriosclerosis Cardiovascular Diseases Coronary Disease Heart Diseases Myocardial Ischemia Vascular Diseases

Age range

18 year–100 year

Sex eligibility

All sexes

Study type

Observational

Primary location

Maastricht University Medical Center

Maastricht, Limburg, 6202AZ, Netherlands

About this study

A known disadvantage of constantly improving diagnostic imaging is the detection of incidental findings. Computed Tomography (CT) scanner technology is ever improving in both temporal and spatial resolution. Recently developed advanced reconstruction algorithms and dedicated post-processing software reduce image noise thereby improving image quality. Equipped with these advancements, modern CT scanners accomplish well defined imaging of cardiovascular structures. These technical improvements have enabled cardiac assessment on routine standard (non-ECG triggered) thoracic CT scans.

If thoracic radiologists are able to assess the heart and coronary arteries on a standard thoracic CT, this could result in an extensive amount of incidental cardiac findings. Herein lies the potential for large scale reporting of incidental cardiac findings and, consequently, a huge influx of new 'patients' for downstream testing and potential (over-)treatment.

Coronary Artery Disease (CAD) is a known comorbidity for multiple diseases, for example presence of CAD could require a different treatment strategy in lung cancer and worsen prognosis [Khakoo et al]. In patients with diabetes mellitus (DM), the incidence of CAD is four times higher compared with the general population, and the risk of a cardiovascular event is two- to four-fold higher [Kannel et al. + Aktas et al.]. Therefore, the discussion on management and treatment of these patients with incidental cardiac findings on chest CT evidently is important. Unfortunately, to date no consensus has been reached on the management and reporting of these findings. The CaPaCT study (cardiac pathologies on standard thoracic CT) has been developed to evaluate the visibility and management of incidental cardiac pathologies on a ultra-high pitch thoracic CT-scan with help of the CAD-RADS classification.

Who can participate

Healthy volunteers accepted: No

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

Inclusion criteria

  • Standard non-ECG triggered thoracic CT scanning.

Exclusion criteria

  • Iodine allergy
  • Renal insufficiency (GFR < 30mL/min)
  • Pregnancy
  • Age < 18 years

Treatment and study plan

Primary outcomes

  1. Evaluate visibility and management of coronary artery disease (CAD)

    Time frame: One year

    Evaluating visibility and management of CAD on standard thoracic CT with help of the CAD-RAD system.

Secondary outcomes

  1. Objective image quality

    Time frame: One year

    Objective image quality of standard thoracic CT scans

  2. Subjective image quality

    Time frame: One year

    Subjective image quality of standard thoracic CT scans

Sponsors and collaborators

Lead sponsor

Maastricht University Medical Center

Other

Collaborators

  • Bayer

Registry information

Official study title

Evaluation of Cardiac Pathologies in Standard Thoracic CT Imaging [CaPaCT]

Acronym: CaPaCT

Important dates

Study start
2016
Primary completion
2018
Study completion
2018
First posted
Sep 16, 2016
Registry last updated
May 2, 2018

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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