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Evaluation of Predictors of Aortic Aneurysm Growth and Rupture

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Disease Information

Descriptive Information
Brief Title † Evaluation of Predictors of Aortic Aneurysm Growth and Rupture
Official Title † Aortic Wall Behavior as a Predictor of Aortic Aneurysm Growth and Rupture
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.
Study Phase N/A
Study Type † Interventional
Study Design † Allocation: Non-Randomized, Intervention Model: Crossover Assignment, Masking: Open Label, Primary Purpose: Diagnostic
Primary Outcome Measure † Time to Growth and/or Rupture of abdominal aortic aneurysm.
Secondary Outcome Measure † Systemic serum biomarkers of AAA will be measured. These markers are circulating levels of Vascular Endothelial Growth Factor, C Reactive Protein, cytokines and osteoprotegerin.
Condition † Abdominal Aortic Aneurysm
Intervention † Procedurecontrast ultrasound
Study Arms / Comparison Groups contrast ultrasound for patients with AAA Contrast ultrasound contrast ultrasound for patients without arterial disease contrast enhanced ultrasound
Publications *

* Includes publications given by the data provider as well as publications identified by National Clinical Trials Identifier (NCT ID) in Medline.

Recruitment Information
Recruitment Status † Procedure
Estimated Enrollment † 145
Start Date † May 2012
Completion Date July 2014
Primary Completion Date July 2014
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
Gender Both
Ages 21 Years - N/A
Accepts Healthy Volunteers Accepts Healthy Volunteers
Contacts ††
Location Countries † United States
Administrative Information
NCT ID † NCT02022436
Organization ID AG042352-01
Secondary IDs †† 1R03AG042352-01
Responsible Party Principal Investigator
Study Sponsor † University of Pittsburgh
Collaborators †† National Institute on Aging (NIA)
Investigators † : ,
Information Provided By
Verification Date December 2013
First Received Date † December 12, 2013
Last Updated Date December 20, 2013
† Required WHO trial registration data element.
†† WHO trial registration data element that is required only if it exists.
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