3D Ultrasound of Abdominal Aortic Aneurysm Characteristics

NCT ID: NCT05871515

Last Updated: 2024-02-01

Basic Information

• Recruitment Status: ACTIVE_NOT_RECRUITING
• Total Enrollment: 20 participants
• Study Classification: OBSERVATIONAL
• Study Start Date: 2022-12-27
• Study Completion Date: 2025-01-31

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

Study Design

• Observational Model Type: COHORT
• Study Time Perspective: PROSPECTIVE

Interventions

3D ultrasound

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

Intervention Type: DEVICE

Eligibility Criteria

Inclusion Criteria

• 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.

Exclusion Criteria

• 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;
• Hypercoagulable status, recent (< 3 months) thrombosis;
• Congestive heart failure (class III or IV);
• Psychiatric or other condition that may interfere with the study;
• Participating in another clinical study that interferes on the primary outcomes of this study;
• 3D US measurement of AAA is impossible because of bowel gasses or other causes.

• Minimum Eligible Age: 18 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Rijnstate Hospital

OTHER

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Principal Investigators

Michel Reijnen, prof. dr.

Role: PRINCIPAL_INVESTIGATOR

Rijnstate hospital, Arnhem, The Netherlands

Locations

Rijnstate Hospital

Arnhem, Non US/Canada, Netherlands

Countries

Netherlands

Other Identifiers

NL81910.091.22

Identifier Type: OTHER

Identifier Source: secondary_id

2021-1929

Identifier Type: -

Identifier Source: org_study_id