X-ray Dose Reduction Study for Cardiac Angiography and Intervention
Study Details
Study Description
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.
| Condition or Disease | Intervention/Treatment | Phase |
|---|---|---|
|
N/A |
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
Arms and Interventions
| Arm | Intervention/Treatment |
|---|---|
| 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 Names:
|
| 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 Names:
|
Outcome Measures
Primary Outcome Measures
- 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
- 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.
Other Outcome Measures
- Radiation Dose Measurements: Air Kerma (AK) [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.
Eligibility Criteria
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
Locations
| Site | City | State | Country | Postal Code | |
|---|---|---|---|---|---|
| 1 | Radboud University Nijmegen Medical Center | Nijmegen | Netherlands | 6500HB |
Sponsors and Collaborators
- Philips Clinical & Medical Affairs Global
Investigators
- Principal Investigator: Harry Suryapranata, Prof Dr., Radboud University Nijmegen Medical Center
Study Documents (Full-Text)
None provided.More Information
Publications
None provided.- XCY607-100084
Study Results
Participant Flow
| Recruitment Details | The enrollment of patients occurred between 11 September and 23 November 2012. |
|---|---|
| Pre-assignment Detail | 50 patients enrolled the study one subject withdrew consent. |
| Arm/Group Title | AlluraXper-ClarityIQ |
|---|---|
| Arm/Group Description | Angiogram with AlluraXper followed by angiogram with ClarityIQ |
| Period Title: Overall Study | |
| STARTED | 49 |
| Collected Dose and Image Information | 39 |
| COMPLETED | 39 |
| NOT COMPLETED | 10 |
Baseline Characteristics
| Arm/Group Title | AlluraXper-ClarityIQ |
|---|---|
| Arm/Group Description | Angiogram with AlluraXper followed by angiogram with ClarityIQ |
| Overall Participants | 49 |
| Age (years) [Mean (Standard Deviation) ] | |
| Mean (Standard Deviation) [years] |
62.8
(11)
|
| Sex: Female, Male (Count of Participants) | |
| Female |
22
44.9%
|
| Male |
27
55.1%
|
| Region of Enrollment (participants) [Number] | |
| Netherlands |
49
100%
|
Outcome Measures
| Title | Image Quality |
|---|---|
| Description | 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. |
| Time Frame | 1 day |
Outcome Measure Data
| Analysis Population Description |
|---|
| All patient with recorded dose information and images for both angiograms were used. |
| Arm/Group Title | AlluraXper-ClarityIQ |
|---|---|
| Arm/Group Description | Angiogram with AlluraXper followed by angiogram with ClarityIQ |
| Measure Participants | 39 |
| Mean (90% Confidence Interval) [proportion of readers] |
0.85
|
| Title | Radiation Dose Measurements: Dose Area Product (DAP) |
|---|---|
| Description | 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. |
| Time Frame | Participants were followed for the duration of the procedure |
Outcome Measure Data
| Analysis Population Description |
|---|
| all patients with recorded dose information and images for both angiograms were included (n=39) |
| Arm/Group Title | AlluraXper-ClarityIQ |
|---|---|
| Arm/Group Description | Angiogram with AlluraXper followed by angiogram with ClarityIQ |
| Measure Participants | 39 |
| Mean (Standard Deviation) [percentage of dose change] |
-52
(14)
|
| Title | Radiation Dose Measurements: Air Kerma (AK) |
|---|---|
| Description | 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. |
| Time Frame | Participants were followed for the duration of the procedure |
Outcome Measure Data
| Analysis Population Description |
|---|
| all patients with recorded dose information and images for both angiograms were included (n=39) |
| Arm/Group Title | AlluraXper-ClarityIQ |
|---|---|
| Arm/Group Description | Angiogram with AlluraXper followed by angiogram with ClarityIQ |
| Measure Participants | 39 |
| Mean (Standard Deviation) [percentage of dose change] |
-53
(12)
|
Adverse Events
| Time Frame | During procedure | |
|---|---|---|
| Adverse Event Reporting Description | ||
| Arm/Group Title | AlluraXper-ClarityIQ | |
| Arm/Group Description | Angiogram with AlluraXper followed by angiogram with ClarityIQ | |
All Cause Mortality |
||
| AlluraXper-ClarityIQ | ||
| Affected / at Risk (%) | # Events | |
| Total | / (NaN) | |
Serious Adverse Events |
||
| AlluraXper-ClarityIQ | ||
| Affected / at Risk (%) | # Events | |
| Total | 2/49 (4.1%) | |
| Cardiac disorders | ||
| Ventricle Fibrillations (VF) | 1/49 (2%) | 1 |
| Type 2 Aorta dissection | 1/49 (2%) | 1 |
Other (Not Including Serious) Adverse Events |
||
| AlluraXper-ClarityIQ | ||
| Affected / at Risk (%) | # Events | |
| Total | 0/49 (0%) | |
Limitations/Caveats
More Information
Certain Agreements
Principal Investigators are NOT employed by the organization sponsoring the study.
The only disclosure restriction on the PI is that the sponsor can review results communications prior to public release and can embargo communications regarding trial results for a period that is less than or equal to 60 days. The sponsor cannot require changes to the communication and cannot extend the embargo.
Results Point of Contact
| Name/Title | Frank Everaerts |
|---|---|
| Organization | Philips |
| Phone | +31630728782 |
| frank.everaerts@philips.com |
- XCY607-100084