Evaluation of Predictors of Aortic Aneurysm Growth and Rupture
Study Details
Study Description
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.
| Condition or Disease | Intervention/Treatment | Phase |
|---|---|---|
|
Phase 2 |
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.
Study Design
Arms and Interventions
| Arm | Intervention/Treatment |
|---|---|
| Active Comparator: contrast ultrasound for patients with AAA Contrast ultrasound |
Drug: contrast ultrasound
Definity® is the contrast agent that will be administered by intravenous injection by a registered nurse during the ultrasound (contrast enhanced ultrasound (CUS). The purpose is to assist in identifying differences in AAA characteristics based on gender and AAA stability and growth.
|
| Active Comparator: contrast ultrasound for patients without arterial disease contrast enhanced ultrasound |
Drug: contrast ultrasound
Definity® is the contrast agent that will be administered by intravenous injection by a registered nurse during the ultrasound (contrast enhanced ultrasound (CUS). The purpose is to assist in identifying differences in AAA characteristics based on gender and AAA stability and growth.
|
Outcome Measures
Primary Outcome Measures
- Time to Growth and/or Rupture of abdominal aortic aneurysm. [Up to 5 years or time of aneurysm repair surgery.]
Prospective contrast ultrasound will be performed at regular clinically indicated timepoints.
Secondary Outcome Measures
- Systemic serum biomarkers of AAA will be measured. These markers are circulating levels of Vascular Endothelial Growth Factor, C Reactive Protein, cytokines and osteoprotegerin. [At the time of contrast ultrasound]
Serum markers will be drawn at each follow up visit until if/when AAA is repaired. They will also be measured 1 year after repair.
Eligibility Criteria
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
Contacts and Locations
Locations
| Site | City | State | Country | Postal Code | |
|---|---|---|---|---|---|
| 1 | University of Pittsburgh Medical Center, Division of Vascular Surgery | Pittsburgh | Pennsylvania | United States | 15232 |
Sponsors and Collaborators
- Rabih A. Chaer
- National Institute on Aging (NIA)
Investigators
- Principal Investigator: Rabih Chaer, MD, UPMC UPP
Study Documents (Full-Text)
None provided.More Information
Publications
None provided.- AG042352-01
- 1R03AG042352-01