Active — Not RecruitingNot Applicable

Vector Velocity Imaging in AAA Patients

Norway14 participantsStarted 2023-04-01

Plain-language 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.

Who can participate

Age range

18 Years

Sex

ALL

See this in plain English?

AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.

Inclusion Criteria: * Diagnosed with AAA * AAA diameter below treatment threshold of 5.5 cm Exclusion Criteria: * 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

Questions worth asking your doctor

Bring these to your next appointment. They're a starting point for a shared conversation — not a sign you qualify or a recommendation to enrol.

1Based on my diagnosis and history, is this trial worth exploring for me — or is there a standard treatment we should try first?
2What does this trial's phase tell us about how much is already known about its safety and benefit?
3What would taking part actually involve for me — visits, tests, time, and travel?
4What are the known and possible risks or side effects I should weigh, and how would they be monitored?
5If this trial isn't the right fit, what other options or trials would you suggest I look into?

Generated to help you prepare — always confirm anything about your own eligibility and care with the study team and your doctor.

Questions for the trial coordinator

The trial coordinator is the person who runs the study day to day. These cover the practical side — logistics, costs, and what taking part would actually mean for your life. The study team confirms whether you meet the criteria; these are questions to ask, not a sign you qualify.

1What does taking part actually involve week to week — how many visits, where, and how long does each one take?
2What costs are covered by the study, and what might I have to pay for myself, including travel, parking, or time off work?
3What happens during screening, and what happens if the study team confirms I don't meet the criteria after those tests?
4Who pays for the scans, blood work, and other tests the trial requires — the study, my insurance, or me?
5How will being in the trial affect my regular care, and will my own doctor stay informed and involved?
6Can I leave the trial at any point if I change my mind, and what would happen to my care if I do?

A starting point for the conversation — always confirm anything about your own eligibility, costs, and care with the study team and your doctor.

What they're measuring

Feasibility scoring for obtaining blood flow measurements in the AAA

Timeframe: Through study completion, an average 6 months

Trial details

NCT IDNCT05841524

SponsorSt. Olavs Hospital

Sponsor typeOTHER

Study typeOBSERVATIONAL

Primary completion2023-12-30

View on ClinicalTrials.gov More Abdominal Aneurysm trials