Evaluation of Predictors of Aortic Aneurysm Growth and Rupture
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.
|Study Design:||Allocation: Non-Randomized
Intervention Model: Crossover Assignment
Masking: Open Label
Primary Purpose: Diagnostic
|Official Title:||Aortic Wall Behavior as a Predictor of Aortic Aneurysm Growth and Rupture|
- Time to Growth and/or Rupture of abdominal aortic aneurysm. [ Time Frame: Up to 5 years or time of aneurysm repair surgery. ] [ Designated as safety issue: No ]Prospective contrast ultrasound will be performed at regular clinically indicated timepoints.
- Systemic serum biomarkers of AAA will be measured. These markers are circulating levels of Vascular Endothelial Growth Factor, C Reactive Protein, cytokines and osteoprotegerin. [ Time Frame: At the time of contrast ultrasound ] [ Designated as safety issue: No ]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.
|Study Start Date:||May 2012|
|Estimated Study Completion Date:||July 2014|
|Estimated Primary Completion Date:||July 2014 (Final data collection date for primary outcome measure)|
Active Comparator: contrast ultrasound for patients with AAA
|Procedure: contrast ultrasound|
Active Comparator: contrast ultrasound for patients without arterial disease
contrast enhanced ultrasound
|Procedure: contrast ultrasound|
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.
Please refer to this study by its ClinicalTrials.gov identifier: NCT02022436
|United States, Pennsylvania|
|University of Pittsburgh Medical Center, Division of Vascular Surgery||Recruiting|
|Pittsburgh, Pennsylvania, United States, 15232|
|Contact: Brimmeier, BSN 412-235-1304 firstname.lastname@example.org|
|Principal Investigator: Rabih Chaer, MD|
|Sub-Investigator: Michel Makaroun, MD|
|Sub-Investigator: Geetha Jeyabalan, MD|
|Sub-Investigator: Edith Tzeng, MD|
|Sub-Investigator: Steven Leers, MD|
|Sub-Investigator: Luke Marone, MD|
|Sub-Investigator: Bryan Tillman, MD|
|Sub-Investigator: Timothy Wu, MD|
|Sub-Investigator: Ashraf Taha, MD|