Non-invasive Aortic Aneurysm Tissue Characterization Using Wall Viscoelasticity

NCT04150653 | Unknown

• 1 other identifier: 19.261
• Study Type: observational
• Target: 30
• Locations: 1 country
• Sites: 1

Brief 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 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.

Conditions

Abdominal Aortic Aneurysm Without Rupture

Keywords

Abdominal aortic aneurysm rupture prevention; Non-invasive vascular elastography by ultrasound; 3D mapping of AAA strain; Vascular vulnerability assessment

Outcome Measures

Primary Outcomes (1)

• AAA strain measurement

  Measure of AAA strain values using imaging exams

  Within less than one month of their surgery

Secondary Outcomes (2)

• AAA strain measurement determined by NIVE

  Within less than one month of their surgery

• AAA strain measurement determined by multiphase CT

  Within less than one month of their surgery

Study Arms (1)

AAA patients

All patients enrolled in phase 1 will undergo: * Multiphase scan CT * Non-invasive vascular ultrasound elastography by ultrasound (NIVE)

Device: Multiphase scan CT, non-invasive vascular ultrasound elastography by ultrasound (NIVE)

Interventions

Multiphase scan CT, non-invasive vascular ultrasound elastography by ultrasound (NIVE) DEVICE

Multiphase scan CT, non-invasive vascular ultrasound elastography by ultrasound (NIVE)

Also known as: Multiphase scan CT, Non-invasive vascular ultrasound elastography by ultrasound (NIVE)

AAA patients

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)
• Sampling Method: Non-Probability Sample

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.

You may qualify if:

• 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.

You may not qualify if:

• 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.

Sponsors & Collaborators

• Centre hospitalier de l'Université de Montréal (CHUM): lead
• McGill University: collaborator
• University of Calgary: collaborator
• Eindhoven University of Technology: collaborator

Study Sites (1)

Centre Hospitalier de l'Université de Montréal

Montreal, Quebec, H2X 0C1, Canada

RECRUITING

Study Officials

• Samuel Kadoury, PhD

  Centre de recherche du centre hospitalier de l'Université de Montréal (CRCHUM) and Polytechnique Montréal

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Samuel Kadoury, PhD

CONTACT

514-890-8000; samuel.kadoury@polymtl.ca

Jennifer Satterthwaite, MSc

CONTACT

514-890-8000; jennifer.satterthwaite.chum@ssss.gouv.qc.ca

Study Design

• Study Type: observational
• Observational Model: CASE ONLY
• Time Perspective: PROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: November 1, 2019
• First Posted: November 5, 2019
• Study Start: September 1, 2020
• Primary Completion: December 31, 2023
• Study Completion: December 31, 2024
• Last Updated: March 10, 2023

Record last verified: 2023-03

Data Sharing

• IPD Sharing: Will not share

Locations

CA (1)