Vascular Diseases
Conditions
Keywords
X-rays, Image processing, Cardiovascular procedure
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.
Interventions
RADIATIONAngiographic run with new algorithm and low dose (50% dose)
Angiographic run with new algorithm and low dose (50% lower dose compared to Xper)
RADIATIONAngiographic run with predecessor algorithm and dose (100%)
Angiographic run with predecessor algorithm and dose (100% dose)
Sponsors
Philips Clinical & Medical Affairs Global
Study design
Allocation
NON_RANDOMIZED
Primary purpose
TREATMENT
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No
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)
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| 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
| Measure | Time frame | Description |
|---|---|---|
| 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
| Measure | Time frame | Description |
|---|---|---|
| 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. |
Countries
Netherlands
Participant flow
Recruitment details
The enrollment of patients occurred between 11 September and 23 November 2012.
Pre-assignment details
50 patients enrolled the study one subject withdrew consent.
Participants by arm
| Arm | Count |
|---|---|
| AlluraXper-ClarityIQ Angiogram with AlluraXper followed by angiogram with ClarityIQ | 49 |
| Total | 49 |
Baseline characteristics
| Characteristic | AlluraXper-ClarityIQ |
|---|---|
| Age, Continuous | 62.8 years STANDARD_DEVIATION 11 |
| Region of Enrollment Netherlands | 49 participants |
| Sex: Female, Male Female | 22 Participants |
| Sex: Female, Male Male | 27 Participants |
Adverse events
| Event type | EG000 affected / at risk |
|---|---|
| deaths Total, all-cause mortality | — / — |
| other Total, other adverse events | 0 / 49 |
| serious Total, serious adverse events | 2 / 49 |
Outcome results
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.
Time frame: 1 day
Population: All patient with recorded dose information and images for both angiograms were used.
| Arm | Measure | Value (MEAN) |
|---|---|---|
| AlluraXper-ClarityIQ | Image Quality | 0.85 proportion of readers |
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.
Time frame: Participants were followed for the duration of the procedure
Population: all patients with recorded dose information and images for both angiograms were included (n=39)
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| AlluraXper-ClarityIQ | Radiation Dose Measurements: Dose Area Product (DAP) | -52 percentage of dose change | Standard Deviation 14 |
Other Pre-specified
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.
Time frame: Participants were followed for the duration of the procedure
Population: all patients with recorded dose information and images for both angiograms were included (n=39)
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| AlluraXper-ClarityIQ | Radiation Dose Measurements: Air Kerma (AK) | -53 percentage of dose change | Standard Deviation 12 |