Clinical trial NCT05871515: 3D Ultrasound of Abdominal Aortic Aneurysm Characteristics
Official title: 3D Ultrasound of Abdominal Aortic Aneurysm Characteristics for Predicting Aneurysm Shrinkage After Endovascular Repair
Study type: OBSERVATIONAL
Overall status: ACTIVE_NOT_RECRUITING
Conditions: Abdominal Aortic Aneurysm
Lead sponsor: Rijnstate Hospital
Sponsor class: OTHER
First posted: 2023-05-23
Enrollment: 20
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: COHORT
Time perspective: PROSPECTIVE
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.

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.


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.

Primary outcomes:
measure: maximum AAA diameter (mm) as measured by 3D non-CEUS, 3D CEUS and CTA
timeFrame: Preoperatively
measure: AAA volume (cm^3) as measured by 3D non-CEUS, 3D CEUS and CTA
timeFrame: Preoperatively
measure: lumen volume (cm^3) as measured by 3D non-CEUS, 3D CEUS and CTA
timeFrame: Preoperatively
measure: thrombus thickness (mm) as measured by 3D non-CEUS, 3D CEUS and CTA
timeFrame: Preoperatively
measure: thrombus volume (cm^3) as measured by 3D non-CEUS, 3D CEUS and CTA
timeFrame: Preoperatively
Secondary outcomes:
measure: Maximum AAA diameter change (mm) one-year after EVAR versus preoperative
timeFrame: 1 year after EVAR
Other outcomes:
Locations:
city: Arnhem
country: Netherlands
facility: Rijnstate Hospital
state: Non US/Canada
Study officials:
affiliation: Rijnstate hospital, Arnhem, The Netherlands
name: Michel Reijnen, prof. dr.
role: PRINCIPAL_INVESTIGATOR
References: