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
Phase 2
Study Type
Interventional
Primary Outcome
Time to Growth and/or Rupture of abdominal aortic aneurysm.
Secondary Outcome
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
contrast ultrasound
Study Arms / Comparison Groups
contrast ultrasound for patients with AAA
Description: Contrast 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
Drug
Estimated Enrollment
75
Start Date
May 2012
Completion Date
February 2022
Primary Completion Date
February 2022
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
All
Ages
21 Years - N/A
Accepts Healthy Volunteers
Accepts Healthy Volunteers
Contacts
Rabih Chaer, MD, ,
Location Countries
United States
Location Countries
United States
Administrative Informations
NCT ID
NCT02022436
Organization ID
AG042352-01
Secondary IDs
1R03AG042352-01
Responsible Party
Sponsor-Investigator
Study Sponsor
Rabih A. Chaer
Collaborators
National Institute on Aging (NIA)
Study Sponsor
Rabih Chaer, MD, Principal Investigator, UPMC UPP
Verification Date
February 2023