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OpenTrials
Completed

NCT Number: NCT02022436

Evaluation of Predictors 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.

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Key information

Conditions

Abdominal Aortic Aneurysm Aneurysm Aortic Aneurysm Aortic Aneurysm, Abdominal Aortic Diseases Cardiovascular Diseases Vascular Diseases

Age range

21 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 2

Primary location

University of Pittsburgh Medical Center, Division of Vascular Surgery

Pittsburgh, Pennsylvania, 15232, United States

About this study

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.

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

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.

Other names: Definity

Primary outcomes

  1. Annual Aneurysm Growth Rate Between Patients With and Without Micro Bubble Uptake

    Time frame: Up to 5 years or time of aneurysm repair surgery.

    Prospective contrast ultrasound will be performed at regular clinically indicated timepoints.

  2. Number of Participants With Microbubble Uptake

    Time frame: At the first follow-up evaluation at 6 months

    Microbubble uptake was determined on ultrasound evaluation of the abdominal aorta. This was agreed upon by two reading physicians.

Secondary outcomes

  1. Mean Value of Systemic Inflammatory Serum Biomarkers

    Time frame: baseline, 6 months

    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.

Sponsors and collaborators

Lead sponsor

Rabih A. Chaer

Other

Collaborators

  • National Institute on Aging (NIA)

Registry information

Official study title

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

Important dates

Study start
2012
Primary completion
2022
Study completion
2022
First posted
Dec 27, 2013
Registry last updated
Nov 13, 2023

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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