3D Ultrasound of Abdominal Aortic Aneurysm Characteristics

NCT05871515 | Unknown DMC

• 2 other identifiers: 2021-1929NL81910.091.22
• Study Type: observational
• Target: 20
• Locations: 1 country
• Sites: 1

Brief Summary

AAA characteristics are traditionally measured with computed tomography angiography (CTA), however, three-dimensional ultrasound (3D US) is emerging as a novel imaging method for AAAs. With the use of a US contrast agent, the AAA thrombus can also be distinguished from the lumen on the 3D scans. This enables 3D visualization of the AAA and its thrombus without the need for harmful radiation and nephrotoxic contrast agents, as opposed to CTA. In in vitro measurements, 3D US has already been shown to have clinically acceptable error rate with AAA diameter and volume measurement. However, it is unclear whether this is also applicable to in vivo measurements. Therefore, the aim of this prospective study is to compare preoperative 3D US AAA characteristics as measured by 3D US with contrast enhancement (3D CEUS), 3D US without contrast enhancement (3D non-CEUS) and CTA.

Conditions

Abdominal Aortic Aneurysm

Outcome Measures

Primary Outcomes (5)

• maximum AAA diameter (mm) as measured by 3D non-CEUS, 3D CEUS and CTA

  For each imaging modality, the AAA and the lumen will be segmented in specialized segmentation software. Then a centerline will be computed through the lumen and perpendicular to this line, the AAA diameters are measured. From all these diameter measurements, the maximum AAA diameter will then be computed.

  Preoperatively

• AAA volume (cm^3) as measured by 3D non-CEUS, 3D CEUS and CTA

  For each imaging modality, the AAA will be segmented in specialized segmentation software and then the size of the volume will be computed.

  Preoperatively

• lumen volume (cm^3) as measured by 3D non-CEUS, 3D CEUS and CTA

  For each imaging modality, the lumen will be segmented in specialized segmentation software and then the size of the volume will be computed.

  Preoperatively

• thrombus thickness (mm) as measured by 3D non-CEUS, 3D CEUS and CTA

  For each imaging modality, the thrombus will be segmented in specialized segmentation software and then the thrombus thickness will be computed.

  Preoperatively

• thrombus volume (cm^3) as measured by 3D non-CEUS, 3D CEUS and CTA

  For each imaging modality, the thrombus will be segmented in specialized segmentation software and then the size of the volume will be computed.

  Preoperatively

Secondary Outcomes (1)

• Maximum AAA diameter change (mm) one-year after EVAR versus preoperative

  1 year after EVAR

Interventions

3D ultrasound DEVICE

A 3D ultrasound is performed preoperatively to measure various aneurysm characteristics

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

20 subjects with an AAA who are up for EVAR treatment will be included. Participants will be recruited from the Rijnstate hospital.

You may qualify if:

• Unruptured infrarenal or juxtarenal abdominal aortic aneurysm (AAA);
• Scheduled for elective endovascular repair (EVAR);
• Preoperative CTA with iodine contrast available;
• Informed consent form understood and signed.

You may not qualify if:

• BMI\>40 kg/m2
• Symptomatic AAA;
• Implanted pacemaker or ICD;
• Unable to hold breath for ≤7 seconds;
• Pregnant;
• Hypersensitivity to the active substance(s) or any of the excipients in Sonovue;
• Known 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.);
• Prosthetic valves;
• Loss of renal function (GFR \< 31 mL/min), end-stage renal disease;
• End-stage liver disease;
• Sepsis;

Sponsors & Collaborators

• Rijnstate Hospital: lead

Study Sites (1)

Rijnstate Hospital

Arnhem, Non US/Canada, 6800 TA, Netherlands

Location

MeSH Terms

Conditions

Aortic Aneurysm, Abdominal

Condition Hierarchy (Ancestors)

Aortic Aneurysm; Aneurysm; Vascular Diseases; Cardiovascular Diseases; Aortic Diseases

Study Officials

• Michel Reijnen, prof. dr.

  Rijnstate hospital, Arnhem, The Netherlands

  PRINCIPAL INVESTIGATOR

Study Design

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

Study Record Dates

• First Submitted: April 3, 2023
• First Posted: May 23, 2023
• Study Start: December 27, 2022
• Primary Completion: December 13, 2023
• Study Completion: January 1, 2025
• Last Updated: February 1, 2024

Record last verified: 2024-01

Data Sharing

• IPD Sharing: Will not share

Locations

NL (1)