Predictors of AAA Expansion and/or Rupture



Status:Recruiting
Conditions:Cardiology, Cardiology, Cardiology
Therapuetic Areas:Cardiology / Vascular Diseases
Healthy:No
Age Range:45 - Any
Updated:10/11/2018
Start Date:August 1, 2017
End Date:September 1, 2020
Contact:Sean J. English, MD
Email:sjenglish@wustl.edu
Phone:314-362-5707

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Noninvasive Assessment of Abdominal Aortic Aneurysm (AAA) Wall Structural Integrity and Inflammation as Predictors of Expansion and/or Rupture

Eligible subjects in this study will have either a known abdominal aortic aneurysm (AAA) or
because they do not have an AAA (control group).

The purpose of this research study is to further study, through FEA, changes that occur in
the mechanical properties of the aortic wall. The investigator will compare two radiotracers,
18F-FDG and 11C-PBR28 to determine if one provides more useful and reliable information about
inflammation. 18F-FDG and 11C-PBR28 are radioactive drugs that will be used for imaging
during the PET-CT scan. The investigator will also compare the results describing the
mechanical properties of the AAA wall to the degree of inflammation in that wall as
determined by PET-CT imaging to define new and better predictors of AAA growth and/or
rupture.

Eligible subjects in this study will have either a known abdominal aortic aneurysm (AAA) or
because they do not have an AAA (control group).

The aorta serves as the main artery to supply blood flow to the body. It is approximately the
size of a garden hose. Due to the effects of high blood pressure (hypertension),
atherosclerosis (hardening of the arteries), and tobacco use, the aorta may widen and enlarge
to form an aneurysm. An abdominal aortic aneurysm (AAA) is a dilation (enlargement) or
ballooning out of a section of blood vessel caused by disease or weakness in the wall of the
aorta below the level of the kidney arteries. As an AAA dilates and increases in size,
rupture of the AAA may occur. AAA rupture carries a significant risk of death.

Currently, aortic size is the primary factor used to assess aortic rupture risk. There are
other imaging procedures (imaging modalities) that are being used and developed to assess AAA
rupture risk. Finite element analysis (FEA) is a way to study the mechanical properties of
the aortic wall, including areas of stress and strength that are used to calculate rupture
risk. Positron Emission Tomography (PET) utilizes glucose (a form of sugar) labeled with a
radioactivity to look at the metabolic activity and inflammation in the aortic wall.

The purpose of this research study is to further study, through FEA, changes that occur in
the mechanical properties of the aortic wall. The investigator will compare two radiotracers,
18F-FDG and 11C-PBR28 to determine if one provides more useful and reliable information about
inflammation. 18F-FDG and 11C-PBR28 are radioactive drugs that will be used for imaging
during the PET-CT scan. The investigator will also compare the results describing the
mechanical properties of the AAA wall to the degree of inflammation in that wall as
determined by PET-CT imaging to define new and better predictors of AAA growth and/or
rupture.

The radioactive tracers that are used in this study are 18F-fludeoxyglucose (FDG) and
11C-PBR28 (PBR) which stands for Peripheral Benzodiazepine Receptor. 11C-PBR28 is considered
investigational, which means that it has not been approved by the U.S. Food and Drug
Administration. FDG is an approved drug by the FDA, however in this study it is considered
investigational.

Goal: Twenty-four subjects will be recruited for this study. Six control subjects (three
males and three females), will be considered. Control subjects will have known
atherosclerosis, without aneurysmal disease. Six subjects (three males and three females)
with small AAAs (diameter 3.0-4.5cm), six subjects (three males, AAA >5.5cm and three
females, AAA >5.0cm) with AAAs that are indicated for treatment, and six subjects (three
males and three females) with rapidly expanding AAAs (>0.5cm over 6 months and/or >1.0cm over
12 months) will be considered.

Subjects will have blood drawn to perform a genetic test that will look at genes and proteins
to determine subject eligibility. Once the blood work is assessed for eligibility, subjects
will undergo the PET-CT scan. The imaging will take approximately 3 hours to complete.

Inclusion

- All ethnic groups

- 45 years of age or older

- *Must fit into one of the three following groups:

- Control group (atherosclerosis without aneurysmal disease

- Small AAA (3-4.5 cm)

- Rapidly growing AAA (0.5 cm in 6 months or 1 cm in 12 months)

Exclusion

- At risk population (cognitively impaired)

- Any exclusion for PT-CT (i.e., allergy to contrast)

- Any woman planning to become pregnant, suspects pregnancy, pregnant or breastfeeding)

- Any greater than normal potential for cardiac arrest

- Renal disease (eGFR <60 mg/ml/1.73m2)

- Claustrophobic reactions and/or is unable to lie on the exam table for 60 minutes

- Significant radiation exposure via other trials or medical testing
We found this trial at
1
site
660 S Euclid Ave
Saint Louis, Missouri 63110
(314) 362-5000
Principal Investigator: Sean English, M.D.
Phone: 314-747-7828
Washington University School of Medicine Washington University Physicians is the clinical practice of the School...
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