Coronary Artery Disease Clinical Trial
Official title:
Registry for CARDIAC PERFUSION CT
This protocol describes a study whose goal is to collect de-identified Cardiac CT Perfusion (CTP) acquisition parameters and clinical findings from approximately 20 qualified medical facilities. The study uses an electronic data capture tool to collect the de-identified data to create a global multi-center registry. This registry will be used for scientific analysis and publication of pertinent medical trends such as CT utilization, radiation dose, and common cardiovascular findings.
The recently developed technique of Cardiac CT Perfusion (CTP) gathers information on both
coronary anatomy and myocardial perfusion in a single scan. This diagnostic test can detect
the presence of coronary plaque as well as assess the functional significance of a stenosis.
To date, it is estimated that 1000 cases of CTP have been performed in the world. While no
exceptional adverse events have been reported (nor are expected), the image quality and
clinical validation in a multi-center multi-vendor setting has been a marked issue for many
experts in this nascent field. This issue has hampered the clinical utility of this test and
raises concerns about its widespread utilization leading to unnecessary costs and exposure
to radiation.
Historically, the rapid explosion in the use of a related procedure, Cardiac CT Angiography
(CCTA) started in 2004 and was marked by large-scale variation in radiation dose, quality
issues, inappropriate use, and interpretation proficiency. Critics of the rapid growth of
CCTA defamed the procedure for imaging abuse charges and noted unchecked and irresponsible
use radiation.
The purpose of RECRUIT is to prevent this clinical inefficiency from occurring again. The
main goal of RECRUIT is to determine the best practices for optimal acquisition and
interpretation of the CTP images, in an effort to optimize standards before the inevitable
rapid adoption of this potentially revolutionary technology. RECRUIT will aim to maximize
the clinical effectiveness and minimize the clinical risks associated with CTP before the
protocol becomes integrated into the standard-of-care and harmonization of the best
practices is nearly impossible.
RECRUIT will enable select clinics that are currently performing CCTA to perform CTP by
training them on the latest acquisition techniques as provided by the field leaders in CTP.
In addition to providing the acquisition protocol, our researchers will provide the clinical
team with a sophisticated EDC tool that effectively monitors numerous factors that could
influence the quality of the images. Finally, RECRUIT will collect de-identified images from
the sites for analysis in our core lab. Analysis of the images will be correlated with
acquisition techniques and patient factors (i.e. BMI). This information fed back to the
clinical team that performed the procedure in an effort to improve their proficiency. This
process will proceed in an iterative manner, with all endpoints being tracked for reporting
in peer-reviewed literature.
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Time Perspective: Prospective
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