X-ray Dose Reduction Study for Cardiac Angiography and Intervention

Philips

Status: Completed

Conditions: Vascular Diseases

Treatments: Radiation: Angiographic run with new algorithm and low dose (50% dose); Radiation: Angiographic run with predecessor algorithm and dose (100%)

Study type: Interventional

Funder types: Industry

Identifiers

NCT01684826

XCY607-100084

Details and patient eligibility

About

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.

Full 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.

Enrollment: 50 patients

Sex: All

Ages: 18+ years old

Volunteers: No Healthy Volunteers

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)

Trial design

50 participants in 2 patient groups

ClarityIQ

Experimental group

Description:

Angiographic run with new algorithm and low dose (50% dose)

Treatment:

Radiation: Angiographic run with new algorithm and low dose (50% dose)

AlluraXper

Experimental group

Description:

Angiographic run with predecessor algorithm and dose (100% dose)

Treatment:

Radiation: Angiographic run with predecessor algorithm and dose (100%)