Abdominal Aortic AneurysmEchoPIV in AAANCT05148988
Ultrasound Velocimetry in the Abdominal Aorta Before and After Endovascular Aneurysm Repair
An observational study of Abdominal Aortic Aneurysm, run by Rijnstate Hospital at 1 site in Netherlands.
Trial summary
Rationale: An abdominal aortic aneurysm (AAA) is a common vascular disease with a high mortality in case of rupture. The underlying processes initiating aneurysmal degeneration and driving aneurysmal growth remain poorly understood. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Abdominal Aortic Aneurysm
- What is being tested?
- EchoPIV and 4D flow MRI
- How many people
- 12 participants
- Where
- 1 siteNetherlands
- Study dates
- 6 Jul 2022to 22 Aug 2023
- Phase
- Observational
- 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
Study population: Patients with an abdominal aortic aneurysm eligible for endovascular repair using the Endurant II device.
Who may be able to join
- Male or female > 18 years of age
- BMI ≤ 30 kg/m2
- Infrarenal AAA
- Scheduled for elective EVAR with the Endurant II stent graft
- Informed consent form understood and signed, and agrees to all visits
Who cannot join
- Hypersensitivity to the active substance(s) or any of the excipients in Sonovue
- Right-to-left cardiac shunt
- Severe pulmonary hypertension (pulmonary artery pressure > 90mmHg)
- Uncontrolled systemic hypertension
- Severe pulmonary disease (e.g. COPD GOLD 3 or 4, adult respiratory distress syndrome)
- Clinically unstable cardiac disease (recent, < 3 months, or ongoing myocardial infarction, unstable angina at rest, recent percutaneous coronary intervention, clinically worsening cardiac symptoms, severe cardiac arrhythmia's, endocarditis, etc.)
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- Prosthetic valves
- Loss of renal function (GFR < 31 ml/min), end-stage renal disease
- End-stage liver disease
- Sepsis
- Hypercoagulable status, recent (< 3 months) thrombosis
- Congestive heart failure (class III or IV)
- Pregnancy
- MRI exclusion criteria (pacemakers, cerebral vascular clips, claustrophobia)
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Feasibility of Ultrasound Particle Image Velocimetry to Quantify Flow in the Abdominal Aorta Before and After Endovascular Aneurysm Repair
Rationale: An abdominal aortic aneurysm (AAA) is a common vascular disease with a high mortality in case of rupture. The underlying processes initiating aneurysmal degeneration and driving aneurysmal growth remain poorly understood. Local hemodynamics might play a key role in the pathogenesis of AAA, as it is associated with aneurysmal growth, intraluminal thrombus formation and rupture risk. Visualizing and quantifying local blood flow profiles could eventually provide more insight in the underlying mechanisms of aneurysm progression as well as identify smaller AAA with increased vulnerability or larger AAA with low risk of rupture. Consequently, this may improve risk assessment and provide patient-specific therapy guidance. Nowadays, endovascular aneurysm repair (EVAR) is the preferred treatment modality in most patients with an infrarenal AAA. However, EVAR is associated with a relatively high reintervention rate. It is hypothesized that the placement of a stent graft may alter local hemodynamics and subsequent recirculations or flow stagnations promote the onset of thrombosis or micro-emboli. These unfavourable flow conditions might be related to various complications after EVAR, such as limb occlusion, renal dysfunction, and the persistence of type II endoleaks. Visualizing local blood flow profiles after EVAR might provide insight in these (un)favourable conditions. In vivo blood flow quantification is a great challenge, particularly in the abdomen. Advanced ultrasound based techniques, incorporating ultrasound contrast agents and plane wave imaging, proved to be feasible in quantifying aortoiliac blood flow patterns in healthy volunteers.
Objective: The aim of this study is to determine the feasibility of ultrafast contrast-enhanced ultrasound particle image velocimetry (echoPIV) measurements to quantify spatiotemporal blood flow velocity profiles in the abdominal aorta of AAA patients before and after endovascular repair.
Secondary objectives are to determine the correlation between echoPIV and phase-contrast MRI (PC MRI) based measurements to ultimately validate the spatiotemporal velocity profiles obtained with echoPIV. Furthermore, changes in blood flow velocity profiles after placement of a stent graft will be evaluated.
- Conditions
- Abdominal Aortic Aneurysm
- Being tested
- EchoPIV, 4D flow MRI
- Medical subject headings
- Aortic Aneurysm, Abdominal
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
EchoPIVDiagnostic test
All patients will undergo an echoPIV measurement 6 to 8 weeks before and 6 to 8 weeks after endovascular aneurysm repair. These measurements will take place at the Vascular Center of Rijnstate Hospital. A venous cannula will be inserted to enable contrast administration. Ultrasound data will be collected at the caudal renal artery, infrarenal neck, aneurysm sac and both iliac arteries.
4D flow MRIDiagnostic test
A 4D phase-contrast magnetic resonance imaging (4D flow MRI) scan of the abdominal aorta will be obtained 6 to 8 weeks before and 6 to 8 weeks after endovascular aneurysm repair.
| Study group | Role | What they receive |
|---|---|---|
| AAA patients | The entire cohort consists of patients with an abdominal aortic aneurysm eligible for endovascular repair using an Endurant II device. Receives: Diagnostic Test: EchoPIV; Diagnostic Test: 4D flow MRI |
What is being measured
The primary outcome is the main question the study is designed to answer.
Qualitative assessment vector velocity fields
Vector velocity fields derived from the echoPIV data will be used to calculate and visualize the velocity profile. In order to answer the question regarding feasibility of echoPIV the quality of the vector velocity fields will be assessed using three different metrics of which the first one is a qualitative assessment by different observers. Recordings of the contrast-enhanced ultrasound with an overlay of the vector velocity profiles will be reviewed on different topics following a scoring rubrics.
Measured: 6 to 8 weeks after the procedure (endovascular repair)
Contrast-to-background ratio
The contrast-to-background ratio (CBR) is the second metric to assess the outcomes of the echoPIV measurements. The CBR is a quantitative measure for the contrast levels and therefore for the quality of the contrast-enhanced US image. The higher the CBR level (in dB) the higher the intensity of the contrast which is needed for sufficient PIV analysis.
Measured: 6 to 8 weeks after the procedure (endovascular repair)
Vector correlation
The vector correlation is the third metric to assess the outcomes of the echoPIV measurements. The vector correlation demonstrates the tracking performance of the PIV algorithm. The vector correlation provides a unitless value between 0 and 1 in which 0 indicates poor tracking of the microbubble contrast and 1 indicates perfect tracking of the microbubble contrast.
Measured: 6 to 8 weeks after the procedure (endovascular repair)
Secondary outcomes (4)
Correlation echoPIV and 4D flow MRI
EchoPIV derived local hemodynamics will be compared to outcomes of the 4D flow MRI scan.
Measured: 6 to 8 weeks after the procedure (endovascular repair)
Influence of stent-graft placement
EchoPIV derived local hemodynamics prior to- and after placement of the stent-graft will be compared.
Measured: 6 to 8 weeks after the procedure (endovascular repair)
Vorticity
Multiple blood flow parameters will be derived from the echoPIV data. The first one is the vorticity, or the curl of the velocity. The vorticity represents the rotation of particles inside the flow field. This measure can potentially be used to define regions with disturbed blood flow, as a high value (in rad/s) indicates the occurence of a recirculation.
Measured: 6 to 8 weeks after the procedure (endovascular repair)
Vector complexity
The second blood flow parameters derived from the echoPIV data is the vector complexity. Vector complexity is a measure of multi-directional flow, ranging from 0 till 1. a value of 1 means complex flow with all velocity vectors pointing in all directions, whereas a value of 0 means laminar flow with all velocity vectors pointing in the same direction. This measure can potentially be used to indicate regions with disturbed blood flow.
Measured: 6 to 8 weeks after the procedure (endovascular repair)
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted8 Dec 2021
- Study start6 Jul 2022
- Primary completion22 Aug 2023
- Study completion22 Aug 2023
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Abdominal Aortic AneurysmStudies 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
- Observational
- Observational model
- Cohort
- Time perspective
- Prospective
- Enrolment
- 12 participants (actual)
Sponsor and investigators
- Lead sponsor
- Rijnstate Hospital
- Sponsor type
- University, hospital or other
- Collaborators
- University of Twente
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05148988
- Sponsor's protocol ID
- 2021-1917
- Acronym
- EchoPIV in AAA
- Status last verified
- Nov 2024
- First submitted
- 24 Nov 2021
- Last updated
- 21 Nov 2024
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 21 Nov 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Feasibility of Ultrasound Particle Image Velocimetry to Quantify Flow in the Abdominal Aorta Before and After Endovascular Aneurysm Repair
- ClinicalTrials.gov ID
- NCT05148988
- Acronym / sponsor ID
- EchoPIV in AAA / 2021-1917
- Conditions
- Abdominal Aortic Aneurysm
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 12 participants (actual)
- Lead sponsor
- Rijnstate HospitalUniversity, hospital or other
- Collaborators
- University of Twente
- Study start
- 6 Jul 2022 (actual)
- Primary completion
- 22 Aug 2023 (actual)
- Study completion
- 22 Aug 2023 (actual)
- First posted
- 8 Dec 2021 (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.
Rationale: An abdominal aortic aneurysm (AAA) is a common vascular disease with a high mortality in case of rupture. The underlying processes initiating aneurysmal degeneration and driving aneurysmal growth remain poorly understood. Local hemodynamics might play a key role in the pathogenesis of AAA, as it is associated with aneurysmal growth, intraluminal thrombus formation and rupture risk. Visualizing and quantifying local blood flow profiles could eventually provide more insight in the underlying mechanisms of aneurysm progression as well as identify smaller AAA with increased vulnerability or larger AAA with low risk of rupture. Consequently, this may improve risk assessment and provide patient-specific therapy guidance. Nowadays, endovascular aneurysm repair (EVAR) is the preferred treatment modality in most patients with an infrarenal AAA. However, EVAR is associated with a relatively high reintervention rate. It is hypothesized that the placement of a stent graft may alter local hemodynamics and subsequent recirculations or flow stagnations promote the onset of thrombosis or micro-emboli. These unfavourable flow conditions might be related to various complications after EVAR, such as limb occlusion, renal dysfunction, and the persistence of type II endoleaks. Visualizing local blood flow profiles after EVAR might provide insight in these (un)favourable conditions. In vivo blood flow quantification is a great challenge, particularly in the abdomen. Advanced ultrasound based techniques, incorporating ultrasound contrast agents and plane wave imaging, proved to be feasible in quantifying aortoiliac blood flow patterns in healthy volunteers.
Objective: The aim of this study is to determine the feasibility of ultrafast contrast-enhanced ultrasound particle image velocimetry (echoPIV) measurements to quantify spatiotemporal blood flow velocity profiles in the abdominal aorta of AAA patients before and after endovascular repair.
Secondary objectives are to determine the correlation between echoPIV and phase-contrast MRI (PC MRI) based measurements to ultimately validate the spatiotemporal velocity profiles obtained with echoPIV. Furthermore, changes in blood flow velocity profiles after placement of a stent graft will be evaluated.
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| AAA patients | – | Diagnostic Test: EchoPIV, Diagnostic Test: 4D flow MRIThe entire cohort consists of patients with an abdominal aortic aneurysm eligible for endovascular repair using an Endurant II device. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- Patients with an abdominal aortic aneurysm eligible for endovascular repair using the Endurant II device.
Key inclusion criteria (5 listed)
- Male or female > 18 years of age
- BMI ≤ 30 kg/m2
- Infrarenal AAA
- Scheduled for elective EVAR with the Endurant II stent graft
- Informed consent form understood and signed, and agrees to all visits
Key exclusion criteria (14 listed)
- Hypersensitivity to the active substance(s) or any of the excipients in Sonovue
- Right-to-left cardiac shunt
- Severe pulmonary hypertension (pulmonary artery pressure > 90mmHg)
- Uncontrolled systemic hypertension
- Severe pulmonary disease (e.g. COPD GOLD 3 or 4, adult respiratory distress syndrome)
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 |
|---|---|---|
| EchoPIVAll patients will undergo an echoPIV measurement 6 to 8 weeks before and 6 to 8 weeks after endovascular aneurysm repair. These measurements will take place at the Vascular Center of Rijnstate Hospital. A venous cannula will be inserted to enable contrast administration. Ultrasound data will be collected at the caudal renal artery, infrarenal neck, aneurysm sac and both iliac arteries. | Diagnostic test | AAA patients |
| 4D flow MRIA 4D phase-contrast magnetic resonance imaging (4D flow MRI) scan of the abdominal aorta will be obtained 6 to 8 weeks before and 6 to 8 weeks after endovascular aneurysm repair. | Diagnostic test | AAA patients |
Primary outcome
Qualitative assessment vector velocity fields
Time frame: 6 to 8 weeks after the procedure (endovascular repair)
Vector velocity fields derived from the echoPIV data will be used to calculate and visualize the velocity profile. In order to answer the question regarding feasibility of echoPIV the quality of the vector velocity fields will be assessed using three different metrics of which the first one is a qualitative assessment by different observers. Recordings of the contrast-enhanced ultrasound with an overlay of the vector velocity profiles will be reviewed on different topics following a scoring rubrics.
Contrast-to-background ratio
Time frame: 6 to 8 weeks after the procedure (endovascular repair)
The contrast-to-background ratio (CBR) is the second metric to assess the outcomes of the echoPIV measurements. The CBR is a quantitative measure for the contrast levels and therefore for the quality of the contrast-enhanced US image. The higher the CBR level (in dB) the higher the intensity of the contrast which is needed for sufficient PIV analysis.
Vector correlation
Time frame: 6 to 8 weeks after the procedure (endovascular repair)
The vector correlation is the third metric to assess the outcomes of the echoPIV measurements. The vector correlation demonstrates the tracking performance of the PIV algorithm. The vector correlation provides a unitless value between 0 and 1 in which 0 indicates poor tracking of the microbubble contrast and 1 indicates perfect tracking of the microbubble contrast.
4 secondary outcomes
Correlation echoPIV and 4D flow MRI
Time frame: 6 to 8 weeks after the procedure (endovascular repair)
Influence of stent-graft placement
Time frame: 6 to 8 weeks after the procedure (endovascular repair)
Vorticity
Time frame: 6 to 8 weeks after the procedure (endovascular repair)
Vector complexity
Time frame: 6 to 8 weeks after the procedure (endovascular repair)
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 21 Nov 2024.
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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.
The record lists no contact. Use the official record to reach the sponsor.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Abdominal Aortic Aneurysm, run by Rijnstate Hospital at 1 site in Netherlands.
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 5 inclusion and 14 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 21 Nov 2024. 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 Netherlands. 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?
Qualitative assessment vector velocity fields (time frame: 6 to 8 weeks after the procedure (endovascular repair)). The study lists 3 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
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 21 Nov 2024.