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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.
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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| ClarityIQ | Experimental | Angiographic run with new algorithm and low dose (50% dose) |
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| AlluraXper | Experimental | Angiographic run with predecessor algorithm and dose (100% dose) |
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| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| 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) |
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| Measure | Description | Time Frame |
|---|---|---|
| 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 |
| Measure | Description | Time Frame |
|---|---|---|
| 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 |
| Measure | Description | Time Frame |
|---|---|---|
| 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 |
Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Harry Suryapranata, Prof Dr. | Radboud University Nijmegen Medical Center | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Radboud University Nijmegen Medical Center | Nijmegen | 6500HB | Netherlands |
50 patients enrolled the study one subject withdrew consent.
The enrollment of patients occurred between 11 September and 23 November 2012.
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| ID | Title | Description |
|---|---|---|
| FG000 | AlluraXper-ClarityIQ | Angiogram with AlluraXper followed by angiogram with ClarityIQ |
| Title | Milestones | Reasons Not Completed | |||||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Overall Study |
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| ID | Title | Description |
|---|---|---|
| BG000 | AlluraXper-ClarityIQ | Angiogram with AlluraXper followed by angiogram with ClarityIQ |
| Units | Counts |
|---|---|
| Participants |
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| Title | Description | Population Description | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Denominator Units Selected | Denominators | Classes |
|---|---|---|---|---|---|---|---|---|---|
| Age, Continuous | Mean |
| Type | Title | Description | Population Description | Reporting Status | Anticipated Posting Date | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Time Frame | Units Analyzed | Denominator Units Selected | Arm/Group Information | Denominators | Classes | Analyses | |||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| 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. | All patient with recorded dose information and images for both angiograms were used. | Posted | Mean | 90% Confidence Interval | proportion of readers | 1 day |
|
During procedure
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| ID | Title | Description | Deaths (Affected) | Deaths (At Risk) | Serious Events (Affected) | Serious Events (At Risk) | Other Events (Affected) | Other Events (At Risk) |
|---|---|---|---|---|---|---|---|---|
| EG000 | AlluraXper-ClarityIQ | Angiogram with AlluraXper followed by angiogram with ClarityIQ |
| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Ventricle Fibrillations (VF) | Cardiac disorders | Systematic Assessment | defibrillation is done with 150 J |
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| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| Frank Everaerts | Philips | +31630728782 | frank.everaerts@philips.com |
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| ID | Term |
|---|---|
| D014652 | Vascular Diseases |
| ID | Term |
|---|---|
| D002318 | Cardiovascular Diseases |
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| Angiographic run with predecessor algorithm and dose (100%) | Radiation | Angiographic run with predecessor algorithm and dose (100% dose) |
|
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| years |
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| Sex: Female, Male | Count of Participants | Participants |
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| Region of Enrollment | Number | participants |
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| 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. | all patients with recorded dose information and images for both angiograms were included (n=39) | Posted | Mean | Standard Deviation | percentage of dose change | Participants were followed for the duration of the procedure |
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| 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. | all patients with recorded dose information and images for both angiograms were included (n=39) | Posted | Mean | Standard Deviation | percentage of dose change | Participants were followed for the duration of the procedure |
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| 2 |
| 49 |
| 0 |
| 49 |
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| Type 2 Aorta dissection | Cardiac disorders | Systematic Assessment | patient has atypical complaints. Suspected ACS. Troponin negative. Bloodpressure declines. Remaining contrast extra vasal (contrast injection in false lumen). Emergency CT scan made. Confirmed Aorta Dissection. Patient underwent emergency surgery. |
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