Evaluation of Predictors of Aortic Aneurysm Growth and Rupture

Abdominal Aortic Aneurysm Clinical Trial

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT02022436
• Other study ID #: AG042352-01
• Secondary ID: 1R03AG042352-01
• Status: Completed
• Phase: Phase 2
• Start date: May 2012
• Est. completion date: February 2022

Study information

• Verified date: November 2023
• Source: University of Pittsburgh
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 66
• Est. completion date: February 2022
• Est. primary completion date: February 2022
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: All
• Age group: 21 Years and older

Eligibility

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

Related Conditions & MeSH terms

• Abdominal Aortic Aneurysm
• Aneurysm
• Aortic Aneurysm
• Aortic Aneurysm, Abdominal
• Rupture

Intervention

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.

Locations

Country	Name	City	State
United States	University of Pittsburgh Medical Center, Division of Vascular Surgery	Pittsburgh	Pennsylvania

Sponsors (2)

Lead Sponsor	Collaborator
Rabih A. Chaer	National Institute on Aging (NIA)

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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.
Primary	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	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