No registrations found.
ID
Source
Brief title
Health condition
Coronary artery disease, X-ray, image quality
Sponsors and support
Intervention
Outcome measures
Primary outcome
The main study endpoints will be several dedicated and fine-tuned Xres5 EPXs which can be used in combination with I) standard, II) reduced contrast medium concentration and III) reduced radiation dose, imaging conditions.
Secondary outcome
Semi-quantification of diagnostic Image quality performance scored by a blinded international review panel (described below).
Background summary
The study will evaluate and optimize the performance of a new X-ray image processing algorithm for coronary procedures. The study will consist of a pilot phase during which the algorithm will be optimized and evaluated under a variety of imaging conditions. During the subsequent study phase the algorithm will not be changed anymore and image quality will be semi-quantitatively scored comparing images processed with the new algorithm to images with the current Clarity IQ algorithm. This will be done by both the interventional cardiologist performing the study procedure as by a blinded international review panel.
Study objective
Xres5 image processing will allow for radiation dose or contrast concentration or radiation dose reduction while maintaining appropriate diagnostic image quality.
Study design
Only study procedures during the coronary procedure. No follow up.
Intervention
No interventions.
Inclusion criteria
• Subject will be undergoing an elective coronary catheterization.
• For phase la, lc, Id and 2/3: both patients undergoing diagnostic and interventional procedures can be included.
• For phases 1b, only patients undergoing PCI will be included.
• Subject is 18 years of age or older, or of legal age to give informed consent per national law.
Exclusion criteria
• Subject with contrast allergies
• Subject with severe kidney disease (e-GFR<60* by Modification of Diet in Renal Disease (MDRD)/Cockcroft Gault clearance formula and/or upon decision by investigator)
• Subject participates in a potentially confounding drug or device trial during the course of the study.
• Subject meets an exclusion criteria according to national law (e.g. age, pregnant woman, breast feeding woman)
• Subject with overt hyperthyroidism
*for phase Id, 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-GFR30-60 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.
Design
Recruitment
IPD sharing statement
Followed up by the following (possibly more current) registration
Other (possibly less up-to-date) registrations in this register
No registrations found.
In other registers
| Register | ID |
|---|---|
| NTR-new | NL7273 |
| NTR-old | NTR7488 |
| CCMO | NL65015.028.18 |
| OMON | NL-OMON48824 |