Vector Velocity Imaging in AAA Patients

NCT05841524 | Active Not Recruiting

• 1 other identifier: 238649
• Study Type: observational
• Target: 14
• Locations: 1 country
• Sites: 1

Brief Summary

The goal of this observational study is to perform an in vivo feasibility study using real time (3D) ultrasound based vector flow imaging in 10 AAA patients (5 with intraluminal thrombus and 5 without intraluminal thrombus). Furthermore, the investigators will investigate the added value of contrast microbubbles in these high framerate, plane wave ultrasound measurements. Included patients will undergo ultrasound scanning of their AAA, using multiple ultrasound sequences. Sequences will be tested with and without the addition of ultrasound contrast microbubbles.

Conditions

Abdominal Aneurysm; Thrombus

Outcome Measures

Primary Outcomes (1)

• Feasibility scoring for obtaining blood flow measurements in the AAA

  Scoring of the obtained data will be performed by a group of 5 experts

  Through study completion, an average 6 months

Secondary Outcomes (1)

• Additional value of microbubble contrast injections on signal to noise ratio

  Through study completion, an average 6 months

Study Arms (2)

AAA patients, without intraluminal thrombus

patients diagnosed with an abdominal aneurysm, with a diameter below the treatment threshold of 5.5 cm and without intraluminal thrombus.

Diagnostic Test: Vector flow imaging measurement

AAA patients, with intraluminal thrombus

patients diagnosed with an abdominal aneurysm, with a diameter below the treatment threshold of 5.5 cm and with intraluminal thrombus.

Diagnostic Test: Vector flow imaging measurement

Interventions

Vector flow imaging measurement DIAGNOSTIC_TEST

Ultrasound measurement, using high framerate measurement techniques.

AAA patients, with intraluminal thrombus; AAA patients, without intraluminal thrombus

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

Patients diagnosed with an AAA. Both with and without intraluminal thrombus present.

You may qualify if:

• Diagnosed with AAA
• AAA diameter below treatment threshold of 5.5 cm

You may not qualify if:

• Hypersensitivity to the active substance(s) or any of the excipients in Sonovue
• 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

• St. Olavs Hospital: lead
• Norwegian University of Science and Technology: collaborator
• University of Twente: collaborator

Study Sites (1)

St. Olavs hospital, Trondheim University Hospital

Trondheim, Trøndelag, 3250, Norway

Location

MeSH Terms

Conditions

Aortic Aneurysm, Abdominal; Thrombosis

Condition Hierarchy (Ancestors)

Aortic Aneurysm; Aneurysm; Vascular Diseases; Cardiovascular Diseases; Aortic Diseases; Embolism and Thrombosis

Study Officials

• Arne Seternes

  St. Olavs Hospital

  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 12, 2023
• First Posted: May 3, 2023
• Study Start: April 1, 2023
• Primary Completion: December 30, 2023
• Study Completion: January 1, 2026
• Last Updated: June 18, 2025

Record last verified: 2025-06

Data Sharing

• IPD Sharing: Will not share

Locations

NO (1)