Evaluation of Predictors of Aortic Aneurysm Growth and Rupture
NCT ID: NCT02022436
Last Updated: 2023-11-13
Study Results
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View full resultsBasic Information
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COMPLETED
PHASE2
66 participants
INTERVENTIONAL
2012-05-31
2022-02-28
Brief Summary
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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.
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Detailed Description
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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.
Conditions
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Study Design
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NON_RANDOMIZED
CROSSOVER
DIAGNOSTIC
NONE
Study Groups
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contrast ultrasound for patients with AAA
Contrast ultrasound
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.
contrast ultrasound for patients without arterial disease
contrast enhanced ultrasound
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.
Interventions
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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.
Other Intervention Names
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Eligibility Criteria
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Inclusion Criteria
* 21 years of age or older
* ability to give informed consent.
Exclusion Criteria
* Known allergy to Definity
* Unstable cardiopulmonary conditions
* pregnancy
21 Years
ALL
Yes
Sponsors
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National Institute on Aging (NIA)
NIH
Rabih A. Chaer
OTHER
Responsible Party
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Rabih A. Chaer
Associate Professor of Surgery
Principal Investigators
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Rabih Chaer, MD
Role: PRINCIPAL_INVESTIGATOR
UPMC UPP
Locations
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University of Pittsburgh Medical Center, Division of Vascular Surgery
Pittsburgh, Pennsylvania, United States
Countries
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Provided Documents
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Document Type: Study Protocol and Statistical Analysis Plan
Other Identifiers
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AG042352-01
Identifier Type: -
Identifier Source: org_study_id
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