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Evaluation of Predictors of Aortic Aneurysm Growth and Rupture

Primary Purpose

Abdominal Aortic Aneurysm

Status
Completed
Phase
Phase 2
Locations
United States
Study Type
Interventional
Intervention
contrast ultrasound
Sponsored by
Rabih A. Chaer
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional diagnostic trial for Abdominal Aortic Aneurysm

Eligibility Criteria

21 Years - undefined (Adult, Older Adult)All SexesAccepts Healthy Volunteers

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

Sites / Locations

  • University of Pittsburgh Medical Center, Division of Vascular Surgery

Arms of the Study

Arm 1

Arm 2

Arm Type

Active Comparator

Active Comparator

Arm Label

contrast ultrasound for patients with AAA

contrast ultrasound for patients without arterial disease

Arm Description

Contrast ultrasound

contrast enhanced ultrasound

Outcomes

Primary Outcome Measures

Time to Growth and/or Rupture of abdominal aortic aneurysm.
Prospective contrast ultrasound will be performed at regular clinically indicated timepoints.

Secondary Outcome Measures

Systemic serum biomarkers of AAA will be measured. These markers are circulating levels of Vascular Endothelial Growth Factor, C Reactive Protein, cytokines and osteoprotegerin.
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.

Full Information

First Posted
December 12, 2013
Last Updated
February 27, 2023
Sponsor
Rabih A. Chaer
Collaborators
National Institute on Aging (NIA)
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1. Study Identification

Unique Protocol Identification Number
NCT02022436
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
Study Type
Interventional

2. Study Status

Record Verification Date
February 2023
Overall Recruitment Status
Completed
Study Start Date
May 2012 (Actual)
Primary Completion Date
February 2022 (Actual)
Study Completion Date
February 2022 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor-Investigator
Name of the Sponsor
Rabih A. Chaer
Collaborators
National Institute on Aging (NIA)

4. Oversight

Studies a U.S. FDA-regulated Drug Product
Yes
Studies a U.S. FDA-regulated Device Product
No
Product Manufactured in and Exported from the U.S.
Yes
Data Monitoring Committee
Yes

5. Study Description

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Abdominal Aortic Aneurysm

7. Study Design

Primary Purpose
Diagnostic
Study Phase
Phase 2
Interventional Study Model
Crossover Assignment
Masking
None (Open Label)
Allocation
Non-Randomized
Enrollment
75 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title
contrast ultrasound for patients with AAA
Arm Type
Active Comparator
Arm Description
Contrast ultrasound
Arm Title
contrast ultrasound for patients without arterial disease
Arm Type
Active Comparator
Arm Description
contrast enhanced ultrasound
Intervention Type
Drug
Intervention Name(s)
contrast ultrasound
Intervention Description
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.
Primary Outcome Measure Information:
Title
Time to Growth and/or Rupture of abdominal aortic aneurysm.
Description
Prospective contrast ultrasound will be performed at regular clinically indicated timepoints.
Time Frame
Up to 5 years or time of aneurysm repair surgery.
Secondary Outcome Measure Information:
Title
Systemic serum biomarkers of AAA will be measured. These markers are circulating levels of Vascular Endothelial Growth Factor, C Reactive Protein, cytokines and osteoprotegerin.
Description
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.
Time Frame
At the time of contrast ultrasound

10. Eligibility

Sex
All
Minimum Age & Unit of Time
21 Years
Accepts Healthy Volunteers
Accepts Healthy Volunteers
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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Rabih Chaer, MD
Organizational Affiliation
UPMC UPP
Official's Role
Principal Investigator
Facility Information:
Facility Name
University of Pittsburgh Medical Center, Division of Vascular Surgery
City
Pittsburgh
State/Province
Pennsylvania
ZIP/Postal Code
15232
Country
United States

12. IPD Sharing Statement

Plan to Share IPD
Undecided
IPD Sharing Plan Description
undecided at this time

Learn more about this trial

Evaluation of Predictors of Aortic Aneurysm Growth and Rupture

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