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Evaluation of Predictors of Aortic Aneurysm Growth and Rupture

This study is currently recruiting participants.
Verified October 2017 by Rabih A. Chaer, University of Pittsburgh
Sponsor:
ClinicalTrials.gov Identifier:
NCT02022436
First Posted: December 27, 2013
Last Update Posted: October 5, 2017
The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Know the risks and potential benefits of clinical studies and talk to your health care provider before participating. Read our disclaimer for details.
Collaborator:
National Institute on Aging (NIA)
Information provided by (Responsible Party):
Rabih A. Chaer, University of Pittsburgh
  Purpose

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.


Condition Intervention Phase
Abdominal Aortic Aneurysm Drug: contrast ultrasound Phase 2

Study Type: Interventional
Study Design: Allocation: Non-Randomized
Intervention Model: Crossover Assignment
Masking: None (Open Label)
Primary Purpose: Diagnostic
Official Title: Aortic Wall Behavior as a Predictor of Aortic Aneurysm Growth and Rupture

Resource links provided by NLM:


Further study details as provided by Rabih A. Chaer, University of Pittsburgh:

Primary Outcome Measures:
  • Time to Growth and/or Rupture of abdominal aortic aneurysm. [ Time Frame: Up to 5 years or time of aneurysm repair surgery. ]
    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. [ Time Frame: At the time of contrast ultrasound ]
    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.


Estimated Enrollment: 75
Actual Study Start Date: May 2012
Estimated Study Completion Date: July 2020
Estimated Primary Completion Date: July 2020 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
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.
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.

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.

  Eligibility

Information from the National Library of Medicine

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Ages Eligible for Study:   21 Years and older   (Adult, Senior)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   Yes
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
  Contacts and Locations
Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT02022436


Contacts
Contact: Patty Dragone, MSN 412-623-8486 dragpa@upmc.edu
Contact: Ali Arak, BS 412-623-8443 araka@upmc.edu

Locations
United States, Pennsylvania
University of Pittsburgh Medical Center, Division of Vascular Surgery Recruiting
Pittsburgh, Pennsylvania, United States, 15232
Contact: Patty Dragone, MSN    412-623-8486    dragpa@upmc.edu   
Principal Investigator: Rabih Chaer, MD         
Sub-Investigator: Michel Makaroun, MD         
Sub-Investigator: Geetha Jeyabalan, MD         
Sub-Investigator: Edith Tzeng, MD         
Sub-Investigator: Steven Leers, MD         
Sub-Investigator: Luke Marone, MD         
Sub-Investigator: Bryan Tillman, MD         
Sub-Investigator: Timothy Wu, MD         
Sub-Investigator: Ashraf Taha, MD         
Sponsors and Collaborators
University of Pittsburgh
National Institute on Aging (NIA)
  More Information

Responsible Party: Rabih A. Chaer, Associate Professor of Surgery, University of Pittsburgh
ClinicalTrials.gov Identifier: NCT02022436     History of Changes
Other Study ID Numbers: AG042352-01
1R03AG042352-01 ( U.S. NIH Grant/Contract )
First Submitted: December 12, 2013
First Posted: December 27, 2013
Last Update Posted: October 5, 2017
Last Verified: October 2017
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: Undecided
Plan Description: undecided at this time

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

Additional relevant MeSH terms:
Aneurysm
Aortic Aneurysm
Rupture
Aortic Aneurysm, Abdominal
Vascular Diseases
Cardiovascular Diseases
Aortic Diseases
Wounds and Injuries