Safety and feasibility study with a new X-ray processing algorithm (Xres5) for coronary procedures

Completed

• Conditions: coronary artery disease; ischemic heart disease; 10011082

• Registration Number: NL-OMON48824
• Lead Sponsor: Philips

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Results First Posted: 2023-03-10
• Last Update Posted: 11 June 2024

Recruitment & Eligibility

• Status: Completed
• Sex: Not specified
• Target Recruitment: 305

Inclusion Criteria

• Subject will be undergoing an elective coronary catheterization.
• Subject is 18 years of age or older.

Exclusion Criteria

• Contrast allergies
• Severe kidney disease (e-GFR < 60* by Modification of Diet in Renal Disease
(MDRD)/Cockcroft Gault clearance formula and/or upon decision by
investigator/treating physician)
• Participation in a potentially confounding drug or device trial during the
course of the study.
• Exclusion criteria according to national law (e.g. age, pregnant woman,
breast feeding woman)
• Overt hyperthyroidism, *for phase 1d, patients with an e-GFR between 30 and
60 can also be included. In that stage of the study the Xres5 cine EPXs have
already been fine-tuned. Indicating that the risk of, or the need for, an
additional run, and thereby a potential increase in contrast medium exposure
has been eliminated. Furthermore, as fluoroscopy is not meant for diagnosis it
is rarely used in combination with contrast administration. Any dissatisfaction
with Xres5 fluoroscopy IQ, requiring additional fluoroscopy with Clarity
fluoroscopy, will not involve contrast medium administration. For phase 2/3,
patients with an e-GFR 30-60 can also be included if the physician chooses to
use the reduced iodine Xres5 EPX. In that setting the patient could actually
benefit from participation as the total contrast load would be reduced.

Study & Design

• Study Type: Interventional
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
<p>The outcome of the study will be a set of fine-tuned enhanced performance Xres5<br /><br>X-ray protocols (cine and fluoroscopy) for different imaging conditions.</p><br>

Secondary Outcome Measures

Name	Time	Method
<p>1. The lowest achievable concentration of contrast medium and radiation dose<br /><br>which do not cause loss of relevant clinical information in the image.<br /><br>2. A semi-quantitative comparison of IQ and diagnostic performance of reduced<br /><br>radiation and contrast runs processed with Xres5 compared to the standard of<br /><br>care runs.</p><br>