Evaluation of Predictors of Aortic Aneurysm Growth and Rupture

Phase 2

Completed

Brief 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.

Detailed Description: Aim#1: Prospective Contrast Ultrasound (CUS) imaging of patients with AAA to predict AAA growth and test gender differences in rate of growth and rupture.

Aim#2: Serum biomarker testing of patient with AAA. CUS findings will be correlated with serum biomarkers and AAA wall histology.

Prospective Contrast Ultrasound imaging of patients with AAA as part of a pilot feasibility study to predict AAA growth and test gender differences in rate of growth and rupture. CUS findings will be correlated with serum biomarkers and AAA wall histology. Potential significance: This study will evaluate the AAA wall and will be based on detecting areas of increased vasa vasorum density within the aneurysm wall and intraluminal thrombus, which indicate regional ischemia and inflammation of the aortic wall and propensity for weakening, enlargement or rupture. This novel evaluation of the aortic wall in patients with AAA will allow individualized treatment based on the biological potential for growth and rupture.

Recruitment & Eligibility

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

Arm && Interventions

Group	Intervention	Description
contrast ultrasound for patients with AAA	Contrast Ultrasound	Contrast ultrasound
contrast ultrasound for patients without arterial disease	Contrast Ultrasound	contrast enhanced ultrasound

Primary Outcome Measures

Name	Time	Method
Number of Participants With Microbubble Uptake	At the first follow-up evaluation at 6 months	Microbubble uptake was determined on ultrasound evaluation of the abdominal aorta. This was agreed upon by two reading physicians.
Annual Aneurysm Growth Rate Between Patients With and Without Micro Bubble Uptake	Up to 5 years or time of aneurysm repair surgery.	Prospective contrast ultrasound will be performed at regular clinically indicated timepoints.

Secondary Outcome Measures

Name	Time	Method
Mean Value of Systemic Inflammatory Serum Biomarkers	baseline, 6 months	Systemic serum biomarkers of AAA will be measured. These markers are circulating levels of C Reactive Protein, cytokines and osteoprotegerin. Serum markers will be drawn at baseline and at the next follow-up visit which is 6 months after the index visit.