Recruiting

Ultrasound Elastography

Sponsor:

Centre hospitalier de l'Université de Montréal (CHUM)

Code:

NCT04150653

Conditions

Abdominal Aortic Aneurysm Without Rupture

Eligibility Criteria

Sex: All

Age: 18+

Healthy Volunteers: Not accepted

Interventions

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

Study Details

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

Study ID

NCT04150653

Start date

Sep 1, 2020

Status verified date

Mar, 2023

Completion date

Dec 31, 2024

Anticipated

Primary completion date

Dec 31, 2023

Anticipated

Eligibility Criteria

Eligibility Criteria

Sex: All

Age: 18+

Healthy Volunteers: Not accepted

Inclusion Criteria:

  • 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.

Exclusion Criteria:

  • 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.

Study Design

Enrollment

30 participants

Anticipated

Interventions and Outcome Measures

Arms

AAA patients

All patients enrolled in phase 1 will undergo:

  • Multiphase scan CT
  • Non-invasive vascular ultrasound elastography by ultrasound (NIVE)

Interventions

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

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

Primary outcome measure

  • AAA strain measurement [ Time Frame: Within less than one month of their surgery ]

Central Contacts and Locations

Central contacts

Samuel Kadoury, PhD

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

Jennifer Satterthwaite, MSc

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

Locations

Centre Hospitalier de l'Université de Montréal

Recruiting

Montréal, Quebec, Canada, H2X 0C1

Contacts

Samuel Kadoury, PhD

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

Jennifer Satterthwaite, MSc

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

More Information

Sponsor

Centre hospitalier de l'Université de Montréal (CHUM)

Last update posted

Mar 10, 2023

Last verified

Mar, 2023

Keywords

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

Trial information was received from ClinicalTrials.gov and was last updated on 2026-09-10. This information was provided to ClinicalTrials.gov by Centre hospitalier de l'Université de Montréal (CHUM) on 2023-03-10.