Cardiac Pathologies in Standard Thoracic CT Imaging

NCT ID: NCT02904239

Last Updated: 2018-05-02

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Total Enrollment

221 participants

Study Classification

OBSERVATIONAL

Study Start Date

2016-07-31

Study Completion Date

2018-03-05

Brief Summary

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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

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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.

Conditions

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Coronary Artery Disease

Study Design

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Observational Model Type

COHORT

Study Time Perspective

PROSPECTIVE

Eligibility Criteria

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Inclusion Criteria

\- Standard non-ECG triggered thoracic CT scanning.

Exclusion Criteria

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

18 Years

Maximum Eligible Age

100 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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Bayer

INDUSTRY

Sponsor Role collaborator

Maastricht University Medical Center

OTHER

Sponsor Role lead

Responsible Party

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Responsibility Role SPONSOR

Locations

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Maastricht University Medical Center

Maastricht, Limburg, Netherlands

Site Status

Countries

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Netherlands

References

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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.

Reference Type BACKGROUND
PMID: 18797437 (View on PubMed)

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.

Reference Type BACKGROUND
PMID: 430798 (View on PubMed)

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.

Reference Type BACKGROUND
PMID: 15383517 (View on PubMed)

Other Identifiers

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16-4-116

Identifier Type: -

Identifier Source: org_study_id

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