The objectives of the study are to fine-tune the Xres5 algorithm settings (for cine and fluoroscopy) to optimize the image quality (IQ) and assess and feasibility of using the improved IQ of Xres5 processing to reduce radiation dose or contrast…
ID
Source
Brief title
Condition
- Coronary artery disorders
Synonym
Research involving
Sponsors and support
Intervention
Outcome measures
Primary outcome
The outcome of the study will be a set of fine-tuned enhanced performance Xres5
X-ray protocols (cine and fluoroscopy) for different imaging conditions.
Secondary outcome
1. The lowest achievable concentration of contrast medium and radiation dose
which do not cause loss of relevant clinical information in the image.
2. A semi-quantitative comparison of IQ and diagnostic performance of reduced
radiation and contrast runs processed with Xres5 compared to the standard of
care runs.
Background summary
Unprocessed Rontgen images are processed by the imaging chain of an X-ray
system to improve image quality (IQ). Xres5 image processing (for cine and
fluoroscopy) is the next generation image-processing algorithm developed by
Philips Healthcare. Xres5 processing aims to further enhance the visibility of
the vasculature, without boosting the irrelevant background features for
cardiac imaging (optimal signal to noise ratio). The gained IQ can be committed
to improved imaging in difficult imaging situations (e.g. steep angulations and
obese patients). Hence, the enhanced IQ, with improved signal to noise ratio,
might allow for a reduction in contrast medium concentration or radiation dose
without compromising the IQ. Therefore, Xres5 processing has the potential to
decrease the harmful side effects associated with X-ray coronary interventions
(radiation exposure and contrast medium).
Study objective
The objectives of the study are to fine-tune the Xres5 algorithm settings (for
cine and fluoroscopy) to optimize the image quality (IQ) and assess and
feasibility of using the improved IQ of Xres5 processing to reduce radiation
dose or contrast medium concentration for cine coronary angiographies.
Study design
This is a prospective, non-randomized, unblinded, single-center study.
The study includes multiple phases. The initial phase aims to optimize and
fine-tune Xres5 processing while the procedures are performed using standard
radiation dose and contrast concentration. When after several feedback
iterations in sufficiently variable imaging conditions (i.e. slim and obese
patients, calcified and non calcified coronaries, steep angulations etc.)
mutual (physicians and image quality experts) satisfaction is reached, the next
phases will be initiated.
The following phases will assess the feasibility of lowering contrast medium
concentration or radiation dose without loosing relevant clinical information
in the image. The reduction in concentration and dose will be achieved in small
steps (one step per patient) under guidance of the interventional cardiologist.
During these phases the lowest dose and concentration is assessed which do not
cause a significant IQ drop and the algorithm settings for these imaging
conditions are fine-tuned. Subsequently, a phase will follow in which the Xres5
fluoroscopy algorithm will be fine-tuned.
The last phases of the study include a semi-quantitative comparison of IQ and
diagnostic performance of runs processed with Xres5 when either lowered
contrast medium concentration, reduced radiation dose or standard conditions
are used compared to runs acquired under the same angulation etc. in the same
patient while the standard image processing is used (as well as the standard
radiation dose and contrast medium concentration).
Intervention
Live cine image processing with Xres5 (Phase 1a) during cardiac catheterization
and live Xres5 fluoroscopy processing (Phase 1d, 2/3).
+ (at least) one cine run performed with a lower contrast medium concentration
or radiation dose (phase 1b, 1c, 2 and 3)
Study burden and risks
Participation to the study is associated with a burden to the patient. There is
no follow up in the study nor will there be any restrictions for participating
patients.
The risk of participating is very small. As this is a feasibility study there
is a small risk that the run acquired with a reduced iodine concentration or
ultralow radiation dose will need to be repeated due to insufficient image
quality. This will expose the patient to slightly more contrast medium and
radiation.
Veenpluis 6
Best 5684 PC
NL
Veenpluis 6
Best 5684 PC
NL
Listed location countries
Age
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.
Design
Recruitment
Medical products/devices used
Followed up by the following (possibly more current) registration
No registrations found.
Other (possibly less up-to-date) registrations in this register
In other registers
| Register | ID |
|---|---|
| CCMO | NL65015.028.18 |