Trial Outcomes & Findings for X-ray Dose Reduction Study for Cardiac Angiography and Intervention (NCT NCT01684826)

NCT ID: NCT01684826

Last Updated: 2022-03-08

Results Overview

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.

• Recruitment status: COMPLETED
• Study phase: NA
• Target enrollment: 50 participants
• Primary outcome timeframe: 1 day
• Results posted on: 2022-03-08

Participant Flow

The enrollment of patients occurred between 11 September and 23 November 2012.

50 patients enrolled the study one subject withdrew consent.

Participant milestones

Measure	AlluraXper-ClarityIQ Angiogram with AlluraXper followed by angiogram with ClarityIQ
Overall Study STARTED	49
Overall Study Collected Dose and Image Information	39
Overall Study COMPLETED	39
Overall Study NOT COMPLETED	10

Reasons for withdrawal

Withdrawal data not reported

Baseline Characteristics

X-ray Dose Reduction Study for Cardiac Angiography and Intervention

Baseline characteristics by cohort

Measure	AlluraXper-ClarityIQ n=49 Participants Angiogram with AlluraXper followed by angiogram with ClarityIQ
Age, Continuous	62.8 years STANDARD_DEVIATION 11 • n=93 Participants
Sex: Female, Male Female	22 Participants n=93 Participants
Sex: Female, Male Male	27 Participants n=93 Participants
Region of Enrollment Netherlands	49 participants n=93 Participants

PRIMARY outcome

Timeframe: 1 day

Population: All patient with recorded dose information and images for both angiograms were used.

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.

Outcome measures

Measure	AlluraXper-ClarityIQ n=39 Participants Angiogram with AlluraXper followed by angiogram with ClarityIQ
Image Quality	0.85 proportion of readers Interval 0.82 to 0.89

SECONDARY outcome

Timeframe: 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)

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.

Outcome measures

Measure	AlluraXper-ClarityIQ n=39 Participants Angiogram with AlluraXper followed by angiogram with ClarityIQ
Radiation Dose Measurements: Dose Area Product (DAP)	-52 percentage of dose change Standard Deviation 14

OTHER_PRE_SPECIFIED outcome

Timeframe: 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)

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.

Outcome measures

Measure	AlluraXper-ClarityIQ n=39 Participants Angiogram with AlluraXper followed by angiogram with ClarityIQ
Radiation Dose Measurements: Air Kerma (AK)	-53 percentage of dose change Standard Deviation 12

Adverse Events

AlluraXper-ClarityIQ

Serious events: 2 serious events

Other events: 0 other events

Deaths: 0 deaths

Serious adverse events

Measure	AlluraXper-ClarityIQ n=49 participants at risk Angiogram with AlluraXper followed by angiogram with ClarityIQ
Cardiac disorders Ventricle Fibrillations (VF)	2.0% 1/49 • Number of events 1 • During procedure
Cardiac disorders Type 2 Aorta dissection	2.0% 1/49 • Number of events 1 • During procedure

Other adverse events

Adverse event data not reported

Additional Information

Frank Everaerts

Philips

Phone: +31630728782

Email: frank.everaerts@philips.com

Results disclosure agreements

• Principal investigator is a sponsor employee
• Publication restrictions are in place

Restriction type: LTE60