Ultra Low Iodine Loaded Spectral CT Angiography (CTA)

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

NA

Total Enrollment

216 participants

Study Classification

INTERVENTIONAL

Study Start Date

2019-01-28

Study Completion Date

2020-10-16

Brief Summary

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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.

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Detailed Description

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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.

Conditions

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Peripheral Arterial Disease Renal Insufficiency

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

RCT: Patients assigned to study or control group

Primary Study Purpose

DIAGNOSTIC

Blinding Strategy

SINGLE

Participants

Participants are not informed of which arm they are assigned to.

Study Groups

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Half iodine - Spectral CT group

Patients receive half dosage of iodine contrast agent, and Spectral CT acquisition with Virtual Monoenergetic Images at 40 and 50 kiloelectronVolts (keV).

Group Type EXPERIMENTAL

Half iodine Spectral CT

Intervention Type DIAGNOSTIC_TEST

Patients receive half dosage of iodine contrast agent, and Spectral CT acquisition with Virtual Monoenergetic Images at 40 and 50 keV.

Standard iodine - Conventional CT

Patients receive standard dosage of iodine contrast agent, and conventional 120 kiloVolts (kV) polychromatic CT images

Group Type ACTIVE_COMPARATOR

Standard iodine conventional CT

Intervention Type DIAGNOSTIC_TEST

Patients receive standard dosage of iodine contrast agent, and conventional 120 kv Polychromatic CT acquisition.

Interventions

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Half iodine Spectral CT

Patients receive half dosage of iodine contrast agent, and Spectral CT acquisition with Virtual Monoenergetic Images at 40 and 50 keV.

Intervention Type DIAGNOSTIC_TEST

Standard iodine conventional CT

Patients receive standard dosage of iodine contrast agent, and conventional 120 kv Polychromatic CT acquisition.

Intervention Type DIAGNOSTIC_TEST

Eligibility Criteria

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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.