An interventional study of Half iodine Spectral CT and Standard iodine conventional CT in Peripheral Arterial Disease and Renal Insufficiency, sponsored by University Hospital, Akershus. Completed at 1 site in Norway. Open to participants aged 18 Years and older. Per ClinicalTrials.gov, last updated 2022-08-05.
Sponsored by University Hospital, Akershus · Not applicable, Interventional, and Diagnostic
The objectives of this study are:
Evaluation of ultra-low iodine load CTA protocols of the aorta and lower extremities.
To investigate whether dual-layer in combination with with virtual monoenergetic imaging (VMI) allows for reduction of contrast medium (CM) in CTA of the aorta and lower limbs i with sustained objective and subjective image quality parameters.
CT angiography (CTA) of the aorta and the lower limb is one of the most important tools for diagnostic, evaluation of the severity of the peripheral arterial disease, decision making, treatment planning and follow-up; but usually requires the use of iodine contrast medium.
Due to the high prevalence of renal impairment (eGFR \< 90 ml/min/1.73m) in the elderly hospitalized population (more than 90% among inpatients aged over 60 years) contrast-medium-induced nephropathy is a major concern in this population.
The recently introduced spectral CT technique utilizes x-rays covering a spectrum of energy-levels as opposed to conventional CT in which x-rays are set to one specific energy level.
This technology offers many possibilities, such as "boosting" the x-ray contrast effect of iodine. This improves the vascular enhancement of the contrast medium using low-energy, virtual monoenergetic imaging (VNI).
The objectives of this study are:
Evaluation of ultra-low iodine load CTA protocols of the aorta and lower extremities.
To investigate whether dual-layer in combination with with virtual monoenergetic imaging (VMI) allows for reduction of contrast medium (CM) in CTA of the aorta and lower limbs i with sustained objective and subjective image quality parameters.
1,995 studies on the registry are indexed under Renal Insufficiency; 173 are open to participants now.
This study's enrollment of 216 is above the median of 43 across 1,504 interventional studies indexed under Renal Insufficiency.
Browse Renal Insufficiency studies →University Hospital, Akershus is the lead sponsor of 123 studies on the registry; 28 are open to participants now.
Counted across the registry records on this site, refreshed daily.
Exclusion Criteria:
Patients receive half dosage of iodine contrast agent, and Spectral CT acquisition with Virtual Monoenergetic Images at 40 and 50 kiloelectronVolts (keV).
Diagnostic Test: Half iodine Spectral CT
Patients receive standard dosage of iodine contrast agent, and conventional 120 kiloVolts (kV) polychromatic CT images
Diagnostic Test: Standard iodine conventional CT
Patients receive half dosage of iodine contrast agent, and Spectral CT acquisition with Virtual Monoenergetic Images at 40 and 50 keV.
Patients receive standard dosage of iodine contrast agent, and conventional 120 kv Polychromatic CT acquisition.
Mean arterial attenuation
Attenuation (x-ray density) is measured in Hounsfield units (HU) digitally by placing a "region of interest" (ROI) circle in the Aorta, common iliac-, femoral- and popliteal arteries on the CT images acquired at the time of inclusion.
Time frame: Measured on CT images acquired at time of inclusion
Subjective examination quality
Examination quality rated by interventional radiologists on a 4-point scale at the anatomic levels: aorta, common iliac, femoral, popliteal- and calf arteries. Subjective examination quality rating scale: 1. (best) - Excellent: The demarcation of the vessel lumen is excellent, more than sufficient for confident diagnosis or exclusion of stenosis or occlusion. 2. - Good: The demarcation of the vessel lumen is sufficient for confident diagnosis or exclusion of stenosis or occlusion. 3. - Adequate: The demarcation of the vessel lumen is adequate for diagnosis or exclusion of stenosis or occlusion, but with limited confidence. 4. (worst) - Non-diagnostic: There is insufficient demarcation of the vessel lumen for diagnosis or exclusion of stenosis or occlusion.
Time frame: Rated on CT images acquired at time of inclusion
Rate of diagnostic quality angiography
Based on measurements of attenuation in the aorta, common iliac-, femoral- and popliteal arteries. Diagnostic quality defined as arterial attenuation \>200 Hounsfield units (HU)
Time frame: Measured on images acquired at time of inclusion
Image noise
Image noise was defined as the standard deviation of arterial attenuation measurements (see outcome 1) measured in HU digitally by placing a ROI on the CT-images in the aorta, common iliac-, femoral- and popliteal arteries.
Time frame: Measured on CT-images acquired at time of inclusion
Contrast to noise ratio (CNR)
Contrast to noise ratio was defined as: (Arterial attenuation - Background attenuation) / Image noise Arterial attenuation: (see outcome 1) measured in HU digitally by placing a ROI on the CT-images in the aorta, common iliac-, femoral- and popliteal arteries. Background attenuation: defined as attenuation in muscle measured in HU digitally by placing an identical size ROI on the CT-images in muscle tissue at the same anatomical levels as the arterial measurements. Image noise: see outcome 4
Time frame: Measured on CT-images acquired at time of inclusion
Signal to noise ratio (SNR)
Signal to noise ratio was defined as: Arterial attenuation / Image noise Arterial attenuation: (see outcome 1) measured in HU digitally by placing a ROI on the CT-images in the aorta, common iliac-, femoral- and popliteal arteries. Image noise: see outcome 4
Time frame: Measured on CT-images acquired at time of inclusion
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University Hospital, Akershus