Clinical trial NCT05488899: Ultra Low Iodine Loaded Spectral CT Angiography (CTA)
Official title: Ultra Low Iodine Loaded Spectral CT Angiography (CTA) of the Aorta and Lower Limb: A Randomized Controlled Trial
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Peripheral Arterial Disease
Renal Insufficiency
Keywords: Computed Tomography Angiography
Contrast Media
Lead sponsor: University Hospital, Akershus
Sponsor class: OTHER
Collaborators: name: Oslo Metropolitan University
First posted: 2022-08-05
Enrollment: 216
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Intervention model description: RCT: Patients assigned to study or control group
Primary purpose: DIAGNOSTIC

Brief summary: 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.

Detailed description: 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.

Eligibility criteria: Inclusion Criteria:

* Inpatients and outpatients with kidney function (eGFR) allowing for safe administration of standard contrast dose (as calculated with the OmniVis calculator).
* Patients with clinical suspicion of disease of the aorta and/or arteries in the lower limb.
* Referral to CTA diagnosis, treatment planning or follow-up.

Exclusion Criteria:

* Iodine contrast medium allergy
* Age \< 18 years
* Lack of informed consent
* Critical ischemia of the lower extremities

Primary outcomes:
measure: Mean arterial attenuation
timeFrame: Measured on CT images acquired at time of inclusion
Secondary outcomes:
measure: Subjective examination quality
timeFrame: Rated on CT images acquired at time of inclusion
measure: Rate of diagnostic quality angiography
timeFrame: Measured on images acquired at time of inclusion
Other outcomes:
measure: Image noise
timeFrame: Measured on CT-images acquired at time of inclusion
measure: Contrast to noise ratio (CNR)
timeFrame: Measured on CT-images acquired at time of inclusion
measure: Signal to noise ratio (SNR)
timeFrame: Measured on CT-images acquired at time of inclusion
Locations:
city: Lørenskog
country: Norway
facility: Akershus University Hospital
state: Viken
Study officials:
affiliation: University Hospital, Akershus & Oslo University Hospital
name: Peter M Lauritzen, MD PhD
role: PRINCIPAL_INVESTIGATOR
References: