Clinical trial NCT02904239: Cardiac Pathologies in Standard Thoracic CT Imaging
Official title: Evaluation of Cardiac Pathologies in Standard Thoracic CT Imaging [CaPaCT]
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Coronary Artery Disease
Keywords: Multidetector Computed Tomography
Incidental cardiac findings
Thoracic high-pitch Computed Tomography
Management guidelines
Lead sponsor: Maastricht University Medical Center
Sponsor class: OTHER
Collaborators: name: Bayer
First posted: 2016-09-16
Enrollment: 221
Sex: ALL
Minimum age (years): 18
Maximum age (years): 100
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: COHORT
Time perspective: PROSPECTIVE
Sampling method: PROBABILITY_SAMPLE
Study population: All consecutive patients referred for thoracic CT-scanning.

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.

Eligibility criteria: Inclusion Criteria:

- Standard non-ECG triggered thoracic CT scanning.

Exclusion Criteria:

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

Primary outcomes:
measure: Evaluate visibility and management of coronary artery disease (CAD)
timeFrame: One year
Secondary outcomes:
measure: Objective image quality
timeFrame: One year
measure: Subjective image quality
timeFrame: One year
Other outcomes:
Locations:
city: Maastricht
country: Netherlands
facility: Maastricht University Medical Center
state: Limburg
Study officials:
References:
citation: Khakoo AY, Yeh ET. Therapy insight: Management of cardiovascular disease in patients with cancer and cardiac complications of cancer therapy. Nat Clin Pract Oncol. 2008 Nov;5(11):655-67. doi: 10.1038/ncponc1225. Epub 2008 Sep 16.
citation: Kannel WB, McGee DL. Diabetes and cardiovascular disease. The Framingham study. JAMA. 1979 May 11;241(19):2035-8. doi: 10.1001/jama.241.19.2035.
citation: Aktas MK, Ozduran V, Pothier CE, Lang R, Lauer MS. Global risk scores and exercise testing for predicting all-cause mortality in a preventive medicine program. JAMA. 2004 Sep 22;292(12):1462-8. doi: 10.1001/jama.292.12.1462.