Peripheral Arterial DiseaseNCT05488899
Ultra Low Iodine Loaded Spectral CT Angiography (CTA)
A study testing Half iodine Spectral CT and Standard iodine conventional CT in people with Peripheral Arterial Disease and Renal Insufficiency, run by University Hospital, Akershus at 1 site in Norway.
Trial 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… Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Peripheral Arterial Disease, Renal Insufficiency
- What is being tested?
- Half iodine Spectral CT and Standard iodine conventional CT
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 216 participants
- Where
- 1 siteNorway
- Study dates
- 28 Jan 2019to 16 Oct 2020
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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.
Who cannot join
- Iodine contrast medium allergy
- Age < 18 years
- Lack of informed consent
- Critical ischemia of the lower extremities
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Ultra Low Iodine Loaded Spectral CT Angiography (CTA) of the Aorta and Lower Limb: A Randomized Controlled Trial
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.
Read the 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.
- Conditions
- Peripheral Arterial Disease, Renal Insufficiency
- Being tested
- Half iodine Spectral CT, Standard iodine conventional CT
- Keywords
- Computed Tomography Angiography, Contrast Media
- Medical subject headings
- Peripheral Arterial Disease, Renal Insufficiency
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Half iodine Spectral CTDiagnostic 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 CTDiagnostic test
Patients receive standard dosage of iodine contrast agent, and conventional 120 kv Polychromatic CT acquisition.
| Study group | Role | What they receive |
|---|---|---|
| Half iodine - Spectral CT group | Experimental | Patients receive half dosage of iodine contrast agent, and Spectral CT acquisition with Virtual Monoenergetic Images at 40 and 50 kiloelectronVolts (keV). Receives: Diagnostic Test: Half iodine Spectral CT |
| Standard iodine - Conventional CT | Active comparator | Patients receive standard dosage of iodine contrast agent, and conventional 120 kiloVolts (kV) polychromatic CT images Receives: Diagnostic Test: Standard iodine conventional CT |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: Measured on CT images acquired at time of inclusion
Secondary outcomes (2)
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:
- (best) - Excellent: The demarcation of the vessel lumen is excellent, more than sufficient for confident diagnosis or exclusion of stenosis or occlusion.
- - Good: The demarcation of the vessel lumen is sufficient for confident diagnosis or exclusion of stenosis or occlusion.
- - Adequate: The demarcation of the vessel lumen is adequate for diagnosis or exclusion of stenosis or occlusion, but with limited confidence.
- (worst) - Non-diagnostic: There is insufficient demarcation of the vessel lumen for diagnosis or exclusion of stenosis or occlusion.
Measured: 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)
Measured: Measured on images acquired at time of inclusion
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted5 Aug 2022
- Study start28 Jan 2019
- Primary completion16 Oct 2020
- Study completion16 Oct 2020
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Peripheral Arterial DiseaseStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Diagnosis
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Model description
- RCT: Patients assigned to study or control group
- Masking
- Single blind
- Who is masked
- Participant
- Enrolment
- 216 participants (actual)
Sponsor and investigators
- Lead sponsor
- University Hospital, Akershus
- Sponsor type
- University, hospital or other
- Collaborators
- Oslo Metropolitan University
- Responsible party
- Principal investigator, Peter Maehre Lauritzen, University Hospital, Akershus
- Investigators
- Peter M Lauritzen, MD PhD, Principal investigator, University Hospital, Akershus & Oslo University Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05488899
- Sponsor's protocol ID
- 2018_070
- Status last verified
- Aug 2022
- First submitted
- 21 Jun 2022
- Last updated
- 5 Aug 2022
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Publications
Kristiansen CH, Thomas O, Tran TT, Roy S, Hykkerud DL, Sanderud A, Geitung JT, Lauritzen PM. Halved contrast medium dose in lower limb dual-energy computed tomography angiography-a randomized controlled trial. Eur Radiol. 2023 Sep;33(9):6033-6044. doi: 10.1007/s00330-023-09575-3. Epub 2023 Apr 18.
PubMed 37071166
Study at a glance
From the registry record, last updated by the sponsor on 5 Aug 2022. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Ultra Low Iodine Loaded Spectral CT Angiography (CTA) of the Aorta and Lower Limb: A Randomized Controlled Trial
- ClinicalTrials.gov ID
- NCT05488899
- Acronym / sponsor ID
- 2018_070
- Conditions
- Peripheral Arterial Disease, Renal Insufficiency
- Keywords
- Computed Tomography Angiography, Contrast Media
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 216 participants (actual)
- Lead sponsor
- University Hospital, AkershusUniversity, hospital or other
- Collaborators
- Oslo Metropolitan University
- Study start
- 28 Jan 2019 (actual)
- Primary completion
- 16 Oct 2020 (actual)
- Study completion
- 16 Oct 2020 (actual)
- First posted
- 5 Aug 2022 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Diagnosis
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (participant)
- Number of arms
- 2
- Model description
- RCT: Patients assigned to study or control group
| Arm | Type | Receives |
|---|---|---|
| Half iodine - Spectral CT group | Experimental | Diagnostic Test: Half iodine Spectral CTPatients receive half dosage of iodine contrast agent, and Spectral CT acquisition with Virtual Monoenergetic Images at 40 and 50 kiloelectronVolts (keV). |
| Standard iodine - Conventional CT | Active comparator | Diagnostic Test: Standard iodine conventional CTPatients receive standard dosage of iodine contrast agent, and conventional 120 kiloVolts (kV) polychromatic CT images |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (3 listed)
- 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.
Key exclusion criteria (4 listed)
- Iodine contrast medium allergy
- Age < 18 years
- Lack of informed consent
- Critical ischemia of the lower extremities
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Half iodine Spectral CTPatients receive half dosage of iodine contrast agent, and Spectral CT acquisition with Virtual Monoenergetic Images at 40 and 50 keV. | Diagnostic test | Half iodine - Spectral CT group |
| Standard iodine conventional CTPatients receive standard dosage of iodine contrast agent, and conventional 120 kv Polychromatic CT acquisition. | Diagnostic test | Standard iodine - Conventional CT |
Primary outcome
Mean arterial attenuation
Time frame: Measured on CT images acquired at time of inclusion
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.
2 secondary outcomes
Subjective examination quality
Time frame: Rated on CT images acquired at time of inclusion
Rate of diagnostic quality angiography
Time frame: Measured on images acquired at time of inclusion
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 5 Aug 2022.
- Derived from this study: PubMed 37071166Kristiansen CH, Thomas O, Tran TT, Roy S, Hykkerud DL, Sanderud A, Geitung JT, Lauritzen PM. Halved contrast medium dose in lower limb dual-energy computed tomography angiography-a randomized controlled trial. Eur Radiol. 2023 Sep;33(9):6033-6044. doi: 10.1007/s00330-023-09575-3. Epub 2023 Apr 18.
- Individual participant dataSharing planned: No
Related trials for Peripheral Arterial Disease
Active, not recruiting
SUCCESS (SelUtion, Safety, effiCaCy, hEalth economicS and promS) PTA Study
Peripheral Artery Disease
RecruitingPhase 3
Reducing Adverse Vascular Outcomes With Factor XI Inhibition in Adult Participants With Peripheral Artery Disease
Peripheral Artery Disease (PAD)
Recruiting
The THOR IDE Study
Peripheral Artery Disease, Peripheral Artery Stenosis
Not yet recruiting
Daily Stretching to Improve Walking in Older Patients With Peripheral Artery Disease: The STRETCH PAD Study
Peripheral Artery Disease (PAD), Intermittent Claudication
Recruiting
WIN Ratio Analysis to Determine a Strategy of Non- Invasive SUpport for Respiratory Failure in the EmeRgency Department
Acute Hypoxic Respiratory Failure, Acute Respiratory Distress Syndrome (ARDS)
Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Peter M Lauritzen, MD PhD principal investigator
University Hospital, Akershus & Oslo University Hospital
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Half iodine Spectral CT and Standard iodine conventional CT in people with Peripheral Arterial Disease and Renal Insufficiency, run by University Hospital, Akershus at 1 site in Norway.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 3 inclusion and 4 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 5 Aug 2022. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Norway. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Mean arterial attenuation (time frame: Measured on CT images acquired at time of inclusion). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT05488899, which also lists 1 linked publication.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 5 Aug 2022.