X-ray Dose Reduction Study for Cardiac Angiography and Intervention

Not Applicable

Completed

• Conditions: Vascular Diseases
• Interventions: Radiation: Angiographic run with predecessor algorithm and dose (100%); Radiation: Angiographic run with new algorithm and low dose (50% dose)

• Registration Number: NCT01684826
• Lead Sponsor: Philips Clinical & Medical Affairs Global

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 Timeline

• Study Start: 2012-09
• Study First Submitted: 2012-09-11
• Study First Submitted QC: 2012-09-12
• Study First Posted: 2012-09-13
• Primary Completion: 2012-11
• Study Completion: 2012-11
• Results First Submitted: 2013-08-26
• Results First Submitted QC: 2013-08-26
• Results First Posted: 2013-11-01
• Status Verified: 2022-03
• Last Update Submitted: 2022-03-07
• Last Update Posted: 2022-03-08

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 50

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)

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: Not specified

Arm && Interventions

Group	Intervention	Description
AlluraXper	Angiographic run with predecessor algorithm and dose (100%)	Angiographic run with predecessor algorithm and dose (100% dose)
ClarityIQ	Angiographic run with new algorithm and low dose (50% dose)	Angiographic run with new algorithm and low dose (50% dose)

Primary Outcome Measures

Name	Time	Method
Image Quality	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 Outcome Measures

Name	Time	Method
Radiation Dose Measurements: Dose Area Product (DAP)	Participants were followed for the duration of the procedure	Percentage of change of ClarityIQ vs. AlluraXper in Dose Area Product (DAP) calculated by DAP/frame. Negative percentage means a reduction in dose for ClarityIQ vs. AlluraXper.

Trial Locations

Locations (1)

Radboud University Nijmegen Medical Center; 🇳🇱 Nijmegen, Netherlands