Clinical Validation and Evaluation of ClarityIQ Cardiac Image Processing for Cardiac Angiography and Intervention
Trial Snapshot
- Phase
- Not Applicable
- Status
- Completed
- Enrollment
- 50
- Locations
- 1
- Primary Endpoint
- Image Quality
Study Overview
Brief Summary
ClarityIQ is a novel X-ray imaging technology, that combines advanced real-time image noise reduction algorithms, with state-of-the-art hardware to reduce patient entrance dose significantly. This is realized by anatomy-specific optimization of the full acquisition chain (grid switch, beam filtering, pulse width, spot size, detector and image processing engine) for every clinical task individually. Furthermore, smaller focal spot sizes and shorter pulses are used, which are known to positively influence image quality . The final effect on the clinical image quality is investigated in this study.
Detailed Description
Fluoroscopically guided procedures are associated with a risk of radiation injury to the skin, caused by high peak skin dose. The increasingly complex nature of many of the interventions performed requires the use of significant amounts of radiation for their completion. Of particular relevance to dose reduction concerns are obese patients, for whom additional radiation is often necessary to obtained sufficient diagnostic quality, as well as patients suffering from chronic total coronary occlusions (CTO), for whom long procedures with extended radiation time and contrast usage are common.
In order to introduce a dose reduction technology the most important aspect is to validate the diagnostic image information. Philips has developed a new algorithm that is capable to process images with similar image quality but acquired at lower dose.
Study Design
- Study Type
- Interventional
- Allocation
- Non Randomized
- Primary Purpose
- Treatment
- Masking
- None
Eligibility Criteria
- Ages
- 18 Years to — (Adult, Older Adult)
- Sex
- All
- Accepts Healthy Volunteers
- No
Inclusion Criteria
- •Patients older than 18 years of age undergoing coronary angiography
Exclusion Criteria
- •Patients not willing or unable to give consent to participate
- •Patients already involved in a clinical trial
- •Patients under the age of 18
- •Pregnant women and breastfeeding women
- •Patients with severe kidney disease (eGFR < 60)
Arms & Interventions
ClarityIQ
Angiographic run with new algorithm and low dose (50% dose)
Intervention: Angiographic run with new algorithm and low dose (50% dose) (Radiation)
AlluraXper
Angiographic run with predecessor algorithm and dose (100% dose)
Intervention: Angiographic run with predecessor algorithm and dose (100%) (Radiation)
Outcomes
Primary Outcomes
Image Quality
Time Frame: 1 day
Overall proportion where diagnostic image quality of ClarityIQ is scored equal or better compared to AlluraXper by the blinded readers. Reading is performed by simultaneous visual comparison of the image quality of AlluraXper and ClarityIQ by multiple blinded reviewers.The images are presented in a randomized order. The hypothesis is that the overall proportion where diagnostic image quality of ClarityIQ is scored equal or better is ≥ than 0.80. Combined for all raters, the lower bound of the one-sided 95% CI (lower bound of the two-sided 90% CI)is used.
Secondary Outcomes
- Radiation Dose Measurements: Dose Area Product (DAP)(Participants were followed for the duration of the procedure)