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Completed

NCT Number: NCT01684826

X-ray Dose Reduction Study for Cardiac Angiography and Intervention

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.

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Key information

Conditions

Vascular Diseases Cardiovascular Diseases

Age range

18 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Radboud University Nijmegen Medical Center

Nijmegen, 6500HB, Netherlands

About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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)

Treatment and study plan

Angiographic run with new algorithm and low dose (50% dose)

Radiation

Angiographic run with new algorithm and low dose (50% lower dose compared to Xper)

Other names: ClarityIQ

Angiographic run with predecessor algorithm and dose (100%)

Radiation

Angiographic run with predecessor algorithm and dose (100% dose)

Other names: AlluraXper

Primary outcomes

  1. 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

  1. Radiation Dose Measurements: Dose Area Product (DAP)

    Time frame: 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.

Other outcomes

  1. Radiation Dose Measurements: Air Kerma (AK)

    Time frame: Participants were followed for the duration of the procedure

    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.

Sponsors and collaborators

Lead sponsor

Philips Clinical & Medical Affairs Global

Industry

Registry information

Official study title

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

Important dates

Study start
2012
Primary completion
2012
Study completion
2012
First posted
Sep 13, 2012
Registry last updated
Mar 8, 2022

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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