Abdominal Aortic Aneurysm Without RuptureAAA multiphaseNCT04150653
Non-invasive Aortic Aneurysm Tissue Characterization Using Wall Viscoelasticity
An observational study of Abdominal Aortic Aneurysm Without Rupture, run by Centre hospitalier de l'Université de Montréal (CHUM) at 1 site in Canada.
Trial summary
Abdominal aortic aneurysm (AAA) is an abnormal dilatation of the aorta in the abdomen due to a wall weakening caused by atherosclerosis. While indications for a rupture intervention are based on AAA maximal diameter (MaxD) (5 cm), 23% of ruptured AAAs are less than 5 cm and in large AAAs, rupture rate could be lower… Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Abdominal Aortic Aneurysm Without Rupture
- What is being tested?
- Multiphase scan CT, non-invasive vascular ultrasound elastography by ultrasound (NIVE)
- Type of treatment
- Medical device
- How many people
- 30 participants
- Where
- 1 siteCanada
- Study dates
- 1 Sep 2020to 31 Dec 2024
- 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: The target population is adults with AAA scheduled for elective repair. For the purpose of this study, we will recruit AAA patients seen at the CHUM and Glen campus McGill University.
Who may be able to join
- Patient with a documented AAA (CT-scan or ultrasound less than 6 months before enrollment) with a maximum diameter (max D) between 4.5 cm and 7 cm.
Who cannot join
- Ruptured, symptomatic or not atheromatous aneurysm;
- Renal failure (renal serum clearance <50 mL/min);
- Previous intervention on AAA (general or endovascular surgery);
- BMI >35;
- Atrial fibrillation.
Trial locations and contacts
1 site in 1 country.
Jennifer Satterthwaite, MSc contact
Canada1 site, 1 recruiting
- Recruiting
Centre Hospitalier de l'Université de Montréal
Montreal, Quebec, H2X 0C1
Samuel Kadoury, PhD, 514-890-8000 ext. 31394, samuel.kadoury@polymtl.ca
Jennifer Satterthwaite, MSc, 514-890-8000 ext. 23483, jennifer.satterthwaite.chum@ssss.gouv.qc.ca
About this study
Abdominal aortic aneurysm (AAA) is an abnormal dilatation of the aorta in the abdomen due to a wall weakening caused by atherosclerosis. While indications for a rupture intervention are based on AAA maximal diameter (MaxD) (5 cm), 23% of ruptured AAAs are less than 5 cm and in large AAAs, rupture rate could be lower than expected. We propose to expand and validate our vascular ultrasound elastography software to 3D. Strain maps generated from radiofrequency (RF) data acquired from 30 AAA patients with a matrix-array 3D probe will be registered to conventional CT (phase 1) and validated to a biomechanical for characterization of AAA wall, assessing vulnerability and influence of surrounding tissues (phase 2). At the end of the project, we will have analyzed 3D strain maps to improve patient selection before surgery.
Read the detailed description
BACKGROUND - Abdominal aortic aneurysm (AAA) rupture is the 13th cause of death in North America. The indications for a procedure to prevent rupture are based on AAA maximal diameter. However, it is a dichotomic criteria leading to under or over estimation of rupture risk. Biomechanics based criteria have been investigated using Finite Elements Analysis (FEA). The limitation of FEA is the absence of patient specific biomechanical information. Our team have previously developped a technique to map in-vivo the strain of AAAs, named non-invasive vascular elastography by ultrasound (NIVE). However, it relies on 2D ultrasound series, whereas new matrix- array probes allow a 3D mapping of the strain at a lower temporal resolution. We propose to create a 3D mapping of AAA strain with 3D ultrasound and register the strain mapping on a single phase CT.
In the project, we plan to acquire multi-modal imaging from 30 AAA patients scheduled for an elective repair will be recruited. A 3D NIVE examination and multiphase CT will be performed on each patient within less than one month of their surgery. A portion of the AAA wall will be harvested during surgery to correlate strains with tensile tests and histology. Following the implementation of NIVE processing and 3D registration, the NIVE and multiphase CT strain values will be calculated and if necessary controlled for the measurement of blood pressure, AAA maximal diameter, calcium load, gender and age. A FEA model developed at U of Calgary will be personalized using the calculation of in-vivo strains. Comparison of strain measurement between NIVE and multiphase CT, correlation of strain measurements and personalized FEA with AAA growth will constitute secondary endpoints. Following the complete validation of this personalized model, we anticipate this will provide predictive biomarkers for AAA vulnerability.
OBJECTIVES - Primary objectives: 1. Acquire a multimodal image dataset (multiphase CT, 3D US) from 30 AAA patients undergoing repair surgery (phase 1); 2. Optimize and validate in vitro the NIVE acquisition protocol and the image registration algorithm between NIVE and one phase of the multiphase CT (phase 1); 3. Compare the principal strain distribution assessed with 3D NIVE registered on conventional CT and those imaged with multiphase CT acquisition (phase 1); 4. Validate both approaches with histology and tensile test on AAA samples (phase 2).
Main hypothesis: Strain maps with 3D NIVE registered on single phase CT provide an accurate in-vivo estimation of AAA wall strength and yield similar accuracy to strain from multiphase CT to assess AAA vulnerability.
METHODOLOGY Phase 1 only will be done for the moment - Design: We plan a prospective study involving 30 AAA patients scheduled for elective open repair. For the phase 1 of the study, we will perform in all patients a NIVE examination and multiphase CT within less than one month of their surgery. For the phase 2 of the study, patient undergoing open surgery will be recruited. A portion of the AAA wall will be harvested during surgery (outside of scope of the pilot study) in order to perform biaxial tensile tests and histology examination. Patients will be recruited at the Centre hospitalier de l'Université de Montréal (CHUM) and Glen campus McGill University.
Data analysis: Spearman correlation, accuracy evaluated by mean error and standard deviation, intraclass correlation coefficient, Bland-Altmann analysis, mixed linear model to evaluate the influence of sex, MaxD, pulse pressure, calcification score on strain (NIVE, multiphase CT) measurements.
RATIONALE AND IMPACT - Ruptured AAA (rAAA) is a life-threatening situation which is the 13th mortality cause in USA. Endovascular aneurysm repair (EVAR) is often preferred for rAAA for its lower morbidity and mortality as compared with OR (1.6 versus 5%). But these data show the maximal diameter/rupture relationship to be nonlinear and inaccurate to predict rupture. New imaging biomarkers to predict AAA growth and rupture are therefore needed. There is also a need to personalize the tissue modeling with in vivo assessment of AAA wall strain to improve prediction of AAA rupture or growth. At the end of the study, we anticipate to have complete validation of this non-invasive assessment of AAA wall vulnerability using US-CT fusion,that will constitute the basis of a personalized assessment of AAA vulnerability. The strain mapping can be used to improve patient selection or be incorporated in a FEA model. Our personalized predictive model will also be useful for EVAR procedure simulation, planning and guidance.
- Being tested
- Multiphase scan CT, non-invasive vascular ultrasound elastography by ultrasound (NIVE)
- Keywords
- Abdominal aortic aneurysm rupture prevention, Non-invasive vascular elastography by ultrasound, 3D mapping of AAA strain, Vascular vulnerability assessment
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Multiphase scan CT, non-invasive vascular ultrasound elastography by ultrasound (NIVE)Device
Also called Multiphase scan CT, Non-invasive vascular ultrasound elastography by ultrasound (NIVE)
Multiphase scan CT, non-invasive vascular ultrasound elastography by ultrasound (NIVE)
| Study group | Role | What they receive |
|---|---|---|
| AAA patients | All patients enrolled in phase 1 will undergo:
* Multiphase scan CT
* Non-invasive vascular ultrasound elastography by ultrasound (NIVE) Receives: Device: Multiphase scan CT, non-invasive vascular ultrasound elastography by ultrasound (NIVE) |
What is being measured
The primary outcome is the main question the study is designed to answer.
AAA strain measurement
Measure of AAA strain values using imaging exams
Measured: Within less than one month of their surgery
Secondary outcomes (2)
AAA strain measurement determined by NIVE
Measure of AAA strain using non-invasive vascular elastography by ultrasound (NIVE)
Measured: Within less than one month of their surgery
AAA strain measurement determined by multiphase CT
Measure of AAA strain using multiphase CT scan
Measured: Within less than one month of their surgery
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted5 Nov 2019
- Study start1 Sep 2020
- Primary completion31 Dec 2023 (estimated)
- Study completion31 Dec 2024 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Abdominal Aortic Aneurysm Without RuptureStudies 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
- Case only
- Time perspective
- Prospective
- Enrolment
- 30 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Centre hospitalier de l'Université de Montréal (CHUM)
- Sponsor type
- University, hospital or other
- Collaborators
- McGill University, University of Calgary, Eindhoven University of Technology
- Responsible party
- Sponsor
- Investigators
- Samuel Kadoury, PhD, Principal investigator, Centre de recherche du centre hospitalier de l'Université de Montréal (CRCHUM) and Polytechnique Montréal
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04150653
- Sponsor's protocol ID
- 19.261
- Acronym
- AAA multiphase
- Status last verified
- Mar 2023
- First submitted
- 1 Nov 2019
- Last updated
- 10 Mar 2023
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 10 Mar 2023. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Non-invasive Aortic Aneurysm Tissue Characterization Using Wall Viscoelasticity
- ClinicalTrials.gov ID
- NCT04150653
- Acronym / sponsor ID
- AAA multiphase / 19.261
- Keywords
- Abdominal aortic aneurysm rupture prevention, Non-invasive vascular elastography by ultrasound, 3D mapping of AAA strain, Vascular vulnerability assessment
- Study type
- Observational
- Recruitment status
- Unknown status
- Enrolment
- 30 participants (estimated)
- Lead sponsor
- Centre hospitalier de l'Université de Montréal (CHUM)University, hospital or other
- Collaborators
- McGill University, University of Calgary, Eindhoven University of Technology
- Study start
- 1 Sep 2020 (actual)
- Primary completion
- 31 Dec 2023 (estimated)
- Study completion
- 31 Dec 2024 (estimated)
- First posted
- 5 Nov 2019 (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.
Abdominal aortic aneurysm (AAA) is an abnormal dilatation of the aorta in the abdomen due to a wall weakening caused by atherosclerosis. While indications for a rupture intervention are based on AAA maximal diameter (MaxD) (5 cm), 23% of ruptured AAAs are less than 5 cm and in large AAAs, rupture rate could be lower than expected. We propose to expand and validate our vascular ultrasound elastography software to 3D. Strain maps generated from radiofrequency (RF) data acquired from 30 AAA patients with a matrix-array 3D probe will be registered to conventional CT (phase 1) and validated to a biomechanical for characterization of AAA wall, assessing vulnerability and influence of surrounding tissues (phase 2). At the end of the project, we will have analyzed 3D strain maps to improve patient selection before surgery.
Detailed description
BACKGROUND - Abdominal aortic aneurysm (AAA) rupture is the 13th cause of death in North America. The indications for a procedure to prevent rupture are based on AAA maximal diameter. However, it is a dichotomic criteria leading to under or over estimation of rupture risk. Biomechanics based criteria have been investigated using Finite Elements Analysis (FEA). The limitation of FEA is the absence of patient specific biomechanical information. Our team have previously developped a technique to map in-vivo the strain of AAAs, named non-invasive vascular elastography by ultrasound (NIVE). However, it relies on 2D ultrasound series, whereas new matrix- array probes allow a 3D mapping of the strain at a lower temporal resolution. We propose to create a 3D mapping of AAA strain with 3D ultrasound and register the strain mapping on a single phase CT.
In the project, we plan to acquire multi-modal imaging from 30 AAA patients scheduled for an elective repair will be recruited. A 3D NIVE examination and multiphase CT will be performed on each patient within less than one month of their surgery. A portion of the AAA wall will be harvested during surgery to correlate strains with tensile tests and histology. Following the implementation of NIVE processing and 3D registration, the NIVE and multiphase CT strain values will be calculated and if necessary controlled for the measurement of blood pressure, AAA maximal diameter, calcium load, gender and age. A FEA model developed at U of Calgary will be personalized using the calculation of in-vivo strains. Comparison of strain measurement between NIVE and multiphase CT, correlation of strain measurements and personalized FEA with AAA growth will constitute secondary endpoints. Following the complete validation of this personalized model, we anticipate this will provide predictive biomarkers for AAA vulnerability.
OBJECTIVES - Primary objectives: 1. Acquire a multimodal image dataset (multiphase CT, 3D US) from 30 AAA patients undergoing repair surgery (phase 1); 2. Optimize and validate in vitro the NIVE acquisition protocol and the image registration algorithm between NIVE and one phase of the multiphase CT (phase 1); 3. Compare the principal strain distribution assessed with 3D NIVE registered on conventional CT and those imaged with multiphase CT acquisition (phase 1); 4. Validate both approaches with histology and tensile test on AAA samples (phase 2).
Main hypothesis: Strain maps with 3D NIVE registered on single phase CT provide an accurate in-vivo estimation of AAA wall strength and yield similar accuracy to strain from multiphase CT to assess AAA vulnerability.
METHODOLOGY Phase 1 only will be done for the moment - Design: We plan a prospective study involving 30 AAA patients scheduled for elective open repair. For the phase 1 of the study, we will perform in all patients a NIVE examination and multiphase CT within less than one month of their surgery. For the phase 2 of the study, patient undergoing open surgery will be recruited. A portion of the AAA wall will be harvested during surgery (outside of scope of the pilot study) in order to perform biaxial tensile tests and histology examination. Patients will be recruited at the Centre hospitalier de l'Université de Montréal (CHUM) and Glen campus McGill University.
Data analysis: Spearman correlation, accuracy evaluated by mean error and standard deviation, intraclass correlation coefficient, Bland-Altmann analysis, mixed linear model to evaluate the influence of sex, MaxD, pulse pressure, calcification score on strain (NIVE, multiphase CT) measurements.
RATIONALE AND IMPACT - Ruptured AAA (rAAA) is a life-threatening situation which is the 13th mortality cause in USA. Endovascular aneurysm repair (EVAR) is often preferred for rAAA for its lower morbidity and mortality as compared with OR (1.6 versus 5%). But these data show the maximal diameter/rupture relationship to be nonlinear and inaccurate to predict rupture. New imaging biomarkers to predict AAA growth and rupture are therefore needed. There is also a need to personalize the tissue modeling with in vivo assessment of AAA wall strain to improve prediction of AAA rupture or growth. At the end of the study, we anticipate to have complete validation of this non-invasive assessment of AAA wall vulnerability using US-CT fusion,that will constitute the basis of a personalized assessment of AAA vulnerability. The strain mapping can be used to improve patient selection or be incorporated in a FEA model. Our personalized predictive model will also be useful for EVAR procedure simulation, planning and guidance.
Study design
- Observational model
- Case only
- Time perspective
- Prospective
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| AAA patients | – | Device: Multiphase scan CT, non-invasive vascular ultrasound elastography by ultrasound (NIVE)All patients enrolled in phase 1 will undergo: * Multiphase scan CT * Non-invasive vascular ultrasound elastography by ultrasound (NIVE) |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- The target population is adults with AAA scheduled for elective repair. For the purpose of this study, we will recruit AAA patients seen at the CHUM and Glen campus McGill University.
Key inclusion criteria (1 listed)
- Patient with a documented AAA (CT-scan or ultrasound less than 6 months before enrollment) with a maximum diameter (max D) between 4.5 cm and 7 cm.
Key exclusion criteria (5 listed)
- Ruptured, symptomatic or not atheromatous aneurysm;
- Renal failure (renal serum clearance <50 mL/min);
- Previous intervention on AAA (general or endovascular surgery);
- BMI >35;
- Atrial fibrillation.
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 |
|---|---|---|
| Multiphase scan CT, non-invasive vascular ultrasound elastography by ultrasound (NIVE)Also: Multiphase scan CT, Non-invasive vascular ultrasound elastography by ultrasound (NIVE)Multiphase scan CT, non-invasive vascular ultrasound elastography by ultrasound (NIVE) | Device | AAA patients |
Primary outcome
AAA strain measurement
Time frame: Within less than one month of their surgery
Measure of AAA strain values using imaging exams
2 secondary outcomes
AAA strain measurement determined by NIVE
Time frame: Within less than one month of their surgery
AAA strain measurement determined by multiphase CT
Time frame: Within less than one month of their surgery
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 10 Mar 2023.
- Individual participant dataSharing planned: No
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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.
Jennifer Satterthwaite, MSc contact
Samuel Kadoury, PhD principal investigator
Centre de recherche du centre hospitalier de l'Université de Montréal (CRCHUM) and Polytechnique Montréal
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 Without Rupture, run by Centre hospitalier de l'Université de Montréal (CHUM) at 1 site in Canada.
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 1 inclusion and 5 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: status not confirmed, as of the sponsor's last update on 10 Mar 2023. 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 Canada. 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?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Samuel Kadoury, PhD (514-890-8000 ext. 31394, samuel.kadoury@polymtl.ca), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
AAA strain measurement (time frame: Within less than one month of their surgery). 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 10 Mar 2023.