Cardiac Pathologies in Standard Thoracic CT Imaging

Completed

• Conditions: Coronary Artery Disease

• Registration Number: NCT02904239
• Lead Sponsor: Maastricht University Medical Center

Brief Summary

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.

Detailed Description

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.

Study Timeline

• Study Start: 2016-07
• Study First Submitted: 2016-09-13
• Study First Submitted QC: 2016-09-15
• Study First Posted: 2016-09-16
• Status Verified: 2017-09
• Primary Completion: 2018-03-05
• Study Completion: 2018-03-05
• Last Update Submitted: 2018-04-30
• Last Update Posted: 2018-05-02

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 221

Inclusion Criteria

• Standard non-ECG triggered thoracic CT scanning.

Exclusion Criteria

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

Study & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
Evaluate visibility and management of coronary artery disease (CAD)	One year	Evaluating visibility and management of CAD on standard thoracic CT with help of the CAD-RAD system.

Secondary Outcome Measures

Name	Time	Method
Objective image quality	One year	Objective image quality of standard thoracic CT scans
Subjective image quality	One year	Subjective image quality of standard thoracic CT scans

Trial Locations

Locations (1)

Maastricht University Medical Center; 🇳🇱 Maastricht, Limburg, Netherlands