X-ray Dose Reduction Study for Cardiac Angiography and Intervention

Vascular Diseases Clinical Trial

Official title:

Clinical Validation and Evaluation of ClarityIQ Cardiac Image Processing for Cardiac Angiography and Intervention

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT01684826
• Other study ID #: XCY607-100084
• Status: Completed
• Phase: N/A
• Start date: September 2012
• Est. completion date: November 2012

Study information

• Verified date: March 2022
• Source: Philips Clinical & Medical Affairs Global
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 50
• Est. completion date: November 2012
• Est. primary completion date: November 2012
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

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)

Related Conditions & MeSH terms

• Vascular Diseases

Intervention

Radiation:
• Angiographic run with new algorithm and low dose (50% dose)
Angiographic run with new algorithm and low dose (50% lower dose compared to Xper)
• Angiographic run with predecessor algorithm and dose (100%)
Angiographic run with predecessor algorithm and dose (100% dose)

Locations

Country	Name	City	State
Netherlands	Radboud University Nijmegen Medical Center	Nijmegen

Sponsors (1)

Lead Sponsor	Collaborator
Philips Clinical & Medical Affairs Global

Country where clinical trial is conducted

Netherlands, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Other	Radiation Dose Measurements: Air Kerma (AK)	Percentage of change of ClarityIQ vs. AlluraXper in Air Kerma (AK) calculated by AK/frame. Negative percentage means a reduction in dose for ClarityIQ vs. AlluraXper.	Participants were followed for the duration of the procedure
Primary	Image Quality	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.	1 day
Secondary	Radiation Dose Measurements: Dose Area Product (DAP)	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.	Participants were followed for the duration of the procedure