Evaluation of Predictors of Aortic Aneurysm Growth and Rupture

Aortic Wall Behavior as a Predictor of Aortic Aneurysm Growth and Rupture

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.

Study Overview

• Status: Completed
• Conditions: Abdominal Aortic Aneurysm
• Intervention / Treatment: Drug: Contrast Ultrasound

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 Type: Interventional
• Enrollment (Actual): 66
• Phase: Phase 2

Contacts and Locations

Study Locations

• United States
  • Pennsylvania
    • Pittsburgh, Pennsylvania, United States, 15232
      • University of Pittsburgh Medical Center, Division of Vascular Surgery

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 21 years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: Yes

Description

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

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Diagnostic
• Allocation: Non-Randomized
• Interventional Model: Crossover Assignment
• Masking: None (Open Label)

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Active Comparator: contrast ultrasound for patients with AAA; Contrast ultrasound	Drug: 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 Names: Definity
Active Comparator: contrast ultrasound for patients without arterial disease; contrast enhanced ultrasound	Drug: 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 Names: Definity

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Annual Aneurysm Growth Rate Between Patients With and Without Micro Bubble Uptake	Prospective contrast ultrasound will be performed at regular clinically indicated timepoints.	Up to 5 years or time of aneurysm repair surgery.
Number of Participants With Microbubble Uptake	Microbubble uptake was determined on ultrasound evaluation of the abdominal aorta. This was agreed upon by two reading physicians.	At the first follow-up evaluation at 6 months

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Mean Value of Systemic Inflammatory Serum Biomarkers	Systemic serum biomarkers of AAA will be measured. These markers are circulating levels of C Reactive Protein, cytokines and osteoprotegerin. Serum markers will be drawn at baseline and at the next follow-up visit which is 6 months after the index visit.	baseline, 6 months

Collaborators and Investigators

• Sponsor: Rabih A. Chaer
• Collaborators: National Institute on Aging (NIA)
• Investigators: Principal Investigator: Rabih Chaer, MD, UPMC UPP

Study record dates

Study Major Dates

• Study Start (Actual): May 1, 2012
• Primary Completion (Actual): February 1, 2022
• Study Completion (Actual): February 1, 2022

Study Registration Dates

• First Submitted: December 12, 2013
• First Submitted That Met QC Criteria: December 20, 2013
• First Posted (Estimated): December 27, 2013

Study Record Updates

• Last Update Posted (Actual): November 13, 2023
• Last Update Submitted That Met QC Criteria: November 10, 2023
• Last Verified: November 1, 2023

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Cardiovascular Diseases; Vascular Diseases; Wounds and Injuries; Aortic Diseases; Rupture; Aneurysm; Aortic Aneurysm; Aortic Aneurysm, Abdominal
• Other Study ID Numbers: AG042352-01; 1R03AG042352-01 (U.S. NIH Grant/Contract)

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO
• IPD Plan Description: undecided at this time

Drug and device information, study documents

• 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