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Evaluation of Predictors of Aortic Aneurysm Growth and Rupture

R

Rabih A. Chaer

Status and phase

Completed
Phase 2

Conditions

Abdominal Aortic Aneurysm

Treatments

Drug: Contrast Ultrasound

Study type

Interventional

Funder types

Other
NIH

Identifiers

NCT02022436
1R03AG042352-01 (U.S. NIH Grant/Contract)
AG042352-01

Details and patient eligibility

About

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.

Full 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.

Enrollment

66 patients

Sex

All

Ages

21+ years old

Volunteers

Accepts Healthy Volunteers

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

Trial design

Primary purpose

Diagnostic

Allocation

Non-Randomized

Interventional model

Crossover Assignment

Masking

None (Open label)

66 participants in 2 patient groups

contrast ultrasound for patients with AAA
Active Comparator group
Description:
Contrast ultrasound
Treatment:
Drug: Contrast Ultrasound
contrast ultrasound for patients without arterial disease
Active Comparator group
Description:
contrast enhanced ultrasound
Treatment:
Drug: Contrast Ultrasound

Trial documents
1

Trial contacts and locations

1

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Data sourced from clinicaltrials.gov

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