X-ray Dose Reduction Study for Cardiac Angiography and Intervention

This study has been completed.
Sponsor:
Information provided by (Responsible Party):
Philips Healthcare
ClinicalTrials.gov Identifier:
NCT01684826
First received: September 11, 2012
Last updated: November 7, 2013
Last verified: November 2013
  Purpose

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.


Condition Intervention
Vascular Diseases
Radiation: Angiographic run with new algorithm and low dose (50% dose)
Radiation: Angiographic run with predecessor algorithm and dose (100%)

Study Type: Interventional
Study Design: Allocation: Non-Randomized
Masking: Open Label
Primary Purpose: Treatment
Official Title: Clinical Validation and Evaluation of ClarityIQ Cardiac Image Processing for Cardiac Angiography and Intervention

Resource links provided by NLM:


Further study details as provided by Philips Healthcare:

Primary Outcome Measures:
  • Image Quality [ Time Frame: 1 day ] [ Designated as safety issue: No ]

    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:
  • Radiation Dose Measurements: Dose Area Product (DAP) [ Time Frame: Participants were followed for the duration of the procedure ] [ Designated as safety issue: No ]
    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 Outcome Measures:
  • Radiation Dose Measurements: Air Kerma (AK) [ Time Frame: Participants were followed for the duration of the procedure ] [ Designated as safety issue: No ]
    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.


Enrollment: 50
Study Start Date: September 2012
Study Completion Date: November 2012
Primary Completion Date: November 2012 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: ClarityIQ
Angiographic run with new algorithm and low dose (50% dose)
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)
Other Name: ClarityIQ
Experimental: AlluraXper
Angiographic run with predecessor algorithm and dose (100% dose)
Radiation: Angiographic run with predecessor algorithm and dose (100%)
Angiographic run with predecessor algorithm and dose (100% dose)
Other Name: AlluraXper

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.

  Eligibility

Ages Eligible for Study:   18 Years and older
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Criteria

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)
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT01684826

Locations
Netherlands
Radboud University Nijmegen Medical Center
Nijmegen, Netherlands, 6500HB
Sponsors and Collaborators
Philips Healthcare
Investigators
Principal Investigator: Harry Suryapranata, Prof Dr. Radboud University Nijmegen Medical Center
  More Information

No publications provided

Responsible Party: Philips Healthcare
ClinicalTrials.gov Identifier: NCT01684826     History of Changes
Other Study ID Numbers: XCY607-100084
Study First Received: September 11, 2012
Results First Received: August 26, 2013
Last Updated: November 7, 2013
Health Authority: Netherlands: The Central Committee on Research Involving Human Subjects (CCMO)

Keywords provided by Philips Healthcare:
X-rays
Image processing
Cardiovascular procedure

Additional relevant MeSH terms:
Vascular Diseases
Cardiovascular Diseases

ClinicalTrials.gov processed this record on July 26, 2014