Evaluation of Predictors of Aortic Aneurysm Growth and Rupture

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Abdominal aortic aneurysm
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Cook – Abdominal aortic aneurysm Cordis Corporation – Abdominal Aortic Aneurysm
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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