Phase 2
N=66
Evaluation of Predictors of Aortic Aneurysm Growth and Rupture
Abdominal Aortic Aneurysm
Bottom Line
View on ClinicalTrials.gov: NCT02022436 ↗Enrolled (actual)
66
Serious AEs
0.0%
Results posted
Nov 2023
Primary outcome: Primary: Annual Aneurysm Growth Rate Between Patients With and Without Micro Bubble Uptake — 3.0; 3.2 mm/year
Study Design & Population
- Study type
- Interventional
- Phase
- Phase 2
- Interventions
- Contrast Ultrasound (Drug)
- Age
- Adult, Older Adult · 21+ yrs
- Sex
- All
- Sponsor
- Rabih A. Chaer
- Primary completion
- Feb 2022
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY Annual Aneurysm Growth Rate Between Patients With and Without Micro Bubble Uptake |
3.0; 3.2 | — |
| PRIMARY Number of Participants With Microbubble Uptake |
36 | — |
| SECONDARY Mean Value of Systemic Inflammatory Serum Biomarkers |
225.5; 214.8; 7090.3; 1843.0; 4.2; 2.4 | — |
Summary
The goal is to non-invasively study the metabolic processes within the aortic wall that are thought to explain progression to clinical manifestations of an aortic aneurysm.
Hypothesis is that the non-invasive imaging of Abdominal Aortic Aneurysm (AAA) with contrast ultrasound, coupled with serum biomarker measurements will allow the identification of the vulnerable aortic wall and patients who are at risk of AAA growth or rupture.
Eligibility Criteria
Inclusion Criteria
- Diagnosis of AAA with confirmation of diagnosis of any size aneurysm with imaging.
- 21 years of age or older
- ability to give informed consent.
Exclusion Criteria
- Inability to provide an informed consent
- Known allergy to Definity
- Unstable cardiopulmonary conditions
- pregnancy
Data sourced from ClinicalTrials.gov (NCT02022436). Outcome figures and adverse-event rates are extracted automatically from the registry's posted results and are provided for clinician reference, not as a substitute for the primary publication.