Cardiac Pathologies in Standard Thoracic CT Imaging

Coronary Artery Disease Clinical Trial

— CaPaCT  

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT02904239
• Other study ID #: 16-4-116
• Status: Completed
• Start date: July 2016
• Est. completion date: March 5, 2018

Study information

• Verified date: September 2017
• Source: Maastricht University Medical Center
• Contact: n/a
• Is FDA regulated: No
• Study type: Observational

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 221
• Est. completion date: March 5, 2018
• Est. primary completion date: March 5, 2018
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years to 100 Years

Eligibility

Inclusion Criteria:

• Standard non-ECG triggered thoracic CT scanning.

Exclusion Criteria:

• Iodine allergy

• Renal insufficiency (GFR < 30mL/min)

• Pregnancy

• Age < 18 years

Related Conditions & MeSH terms

• Coronary Artery Disease
• Coronary Disease
• Myocardial Ischemia

Locations

Country	Name	City	State
Netherlands	Maastricht University Medical Center	Maastricht	Limburg

Sponsors (2)

Lead Sponsor	Collaborator
Maastricht University Medical Center	Bayer

Country where clinical trial is conducted

Netherlands, 

References & Publications (3)

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. — View Citation

Kannel WB, McGee DL. Diabetes and cardiovascular disease. The Framingham study. JAMA. 1979 May 11;241(19):2035-8. — View 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. Review. — View Citation

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Evaluate visibility and management of coronary artery disease (CAD)	Evaluating visibility and management of CAD on standard thoracic CT with help of the CAD-RAD system.	One year
Secondary	Objective image quality	Objective image quality of standard thoracic CT scans	One year
Secondary	Subjective image quality	Subjective image quality of standard thoracic CT scans	One year