Evaluation of Predictors of Aortic Aneurysm Growth and Rupture

NCT02022436 | Completed Phase 2 Results DMC FDA Drug

• 2 other identifiers: AG042352-011R03AG042352-01
• Study Type: interventional
• Target: 66
• Locations: 1 country
• Sites: 1

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.

Conditions

Abdominal Aortic Aneurysm

Outcome Measures

Primary Outcomes (2)

• 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 Outcomes (1)

• Mean Value of Systemic Inflammatory Serum Biomarkers

  baseline, 6 months

Study Arms (2)

contrast ultrasound for patients with AAA

ACTIVE COMPARATOR

Contrast ultrasound

Drug: Contrast Ultrasound

contrast ultrasound for patients without arterial disease

ACTIVE COMPARATOR

contrast enhanced ultrasound

Drug: Contrast Ultrasound

Interventions

Contrast Ultrasound DRUG

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.

Also known as: Definity

contrast ultrasound for patients with AAA; contrast ultrasound for patients without arterial disease

Eligibility Criteria

• Age: 21 Years+
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Diagnosis of AAA with confirmation of diagnosis of any size aneurysm with imaging.
• years of age or older
• ability to give informed consent.

You may not qualify if:

• Inability to provide an informed consent
• Known allergy to Definity
• Unstable cardiopulmonary conditions
• pregnancy

Sponsors & Collaborators

• Rabih A. Chaer: lead
• National Institute on Aging (NIA): collaborator

Study Sites (1)

University of Pittsburgh Medical Center, Division of Vascular Surgery

Pittsburgh, Pennsylvania, 15232, United States

Location

MeSH Terms

Conditions

Aortic Aneurysm, Abdominal

Interventions

perflutren

Condition Hierarchy (Ancestors)

Aortic Aneurysm; Aneurysm; Vascular Diseases; Cardiovascular Diseases; Aortic Diseases

Results Point of Contact

• Title: Rabih Chaer
• Organization: University of Pittsburgh Medical Center

chaerra@upmc.edu

4128023025

Study Officials

• Rabih Chaer, MD

  UPMC UPP

  PRINCIPAL INVESTIGATOR

Publication Agreements

• PI is Sponsor Employee: No
• Restrictive Agreement: No

Study Design

• Study Type: interventional
• Phase: phase 2
• Allocation: NON RANDOMIZED
• Masking: NONE
• Purpose: DIAGNOSTIC
• Intervention Model: CROSSOVER
• Sponsor Type: OTHER
• Responsible Party: SPONSOR INVESTIGATOR
• PI Title: Associate Professor of Surgery

Study Record Dates

• First Submitted: December 12, 2013
• First Posted: December 27, 2013
• Study Start: May 1, 2012
• Primary Completion: February 1, 2022
• Study Completion: February 1, 2022
• Last Updated: November 13, 2023
• Results First Posted: November 13, 2023

Record last verified: 2023-11

Data Sharing

• IPD Sharing: Will not share

Locations

US (1)