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Inflammation and Risk Prediction in Patients With Abdominal Aortic Aneurysm

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. Read our disclaimer for details. Identifier: NCT00513773
Recruitment Status : Completed
First Posted : August 9, 2007
Last Update Posted : April 7, 2017
Information provided by (Responsible Party):
Vanderbilt University Medical Center

Tracking Information
First Submitted Date August 8, 2007
First Posted Date August 9, 2007
Last Update Posted Date April 7, 2017
Study Start Date July 2008
Actual Primary Completion Date July 2013   (Final data collection date for primary outcome measure)
Current Primary Outcome Measures
 (submitted: August 8, 2007)
Give more details that may enable us to better assess the chance of AAA expansion or rupture [ Time Frame: 2 Years ]
Original Primary Outcome Measures Same as current
Change History
Current Secondary Outcome Measures Not Provided
Original Secondary Outcome Measures Not Provided
Current Other Pre-specified Outcome Measures Not Provided
Original Other Pre-specified Outcome Measures Not Provided
Descriptive Information
Brief Title Inflammation and Risk Prediction in Patients With Abdominal Aortic Aneurysm
Official Title Inflammation and Risk Prediction in Patients With Abdominal Aortic Aneurysm
Brief Summary The purpose of this study is to better understand the role of inflammation in the pathophysiology of abdominal aortic aneurysm. In this study we hope to show better ways of predicting risk in this condition by using a combination of FDG-PET with CT.
Detailed Description

Cumulative experimental and pathological evidence support the postulate that inflammation may serve as the unifying concept in the pathogenesis of atherosclerosis and its complications. Aneurysmal disease is associated with inflammatory cell infiltrate and enzymatic degradation of the vessel wall. Although the risk of abdominal aortic aneurysm (AAA) rupture relates to the maximum cross-sectional diameter, rapid expansion of the aortic diameters preceding fissuration and rupture has been observed in AAA independently of their initial size. However, current diagnostic modalities stratify risk of AAA rupture based solely on the size of the aneurysm without factoring potentially useful information derivable from the degree of aneurysmal wall inflammatory response.

We propose to utilize fluorodeoxyglucose (FDG) positron emission tomography (PET) imaging co-registered with structural computerized tomography (CT) images for the in vivo localization and quantification of vascular inflammation in patients with AAA in order to determine whether increased inflammation within the walls of the aneurysm correlates with rapid enlargement of AAA (change in aneurysmal diameter within 6 months), symptoms, thrombosis, or intervention for ruptured, leaking, rapidly expanding, or painful AAAs.

In patients with underlying abdominal aortic aneurysm (AAA), the progression of disease i.e. expansion is associated with increased inflammation within the aneurysm wall as characterized by FDG-PET/CT, and the degree of inflammation is a risk predictor for adverse events.

Prior studies have demonstrated that FDG uptake is greater in inflamed tissues, such as infectious foci and tumors. In chronic inflammatory lesions and malignancies, FDG uptake is increased in macrophage-dense regions. The relatively high uptake of FDG by macrophages is attributed to the relatively high metabolic rates of macrophages, and the inability of macrophages to store glycogen, making them more reliant upon external glucose as a source of fuel. Activation of macrophages can further increase their glucose consumption. Both in animal models and humans, inflamed blood vessels have been shown to have an increased uptake of FDG. Several investigators have shown that FDG-PET can reliably detect inflammation in atherosclerosis. Thus detection of enhanced FDG uptake in the aneurysmal walls of patients with AAA may have potential significance.

Study Type Observational
Study Design Observational Model: Cohort
Time Perspective: Prospective
Target Follow-Up Duration Not Provided
Biospecimen Retention:   Samples With DNA
Serum/plasma for biomarker analysis
Sampling Method Non-Probability Sample
Study Population Patients with abdominal aortic aneurysm
Condition Aortic Aneurysm, Abdominal
Intervention Not Provided
Study Groups/Cohorts Not Provided
Publications * Not Provided

*   Includes publications given by the data provider as well as publications identified by Identifier (NCT Number) in Medline.
Recruitment Information
Recruitment Status Completed
Actual Enrollment
 (submitted: April 5, 2017)
Original Estimated Enrollment
 (submitted: August 8, 2007)
Actual Study Completion Date February 2014
Actual Primary Completion Date July 2013   (Final data collection date for primary outcome measure)
Eligibility Criteria

Inclusion Criteria:

  • Patients with AAA between 3 to 5 cm
  • Patients with AAA > 5cm in whom the risk of operative intervention is prohibitive in the opinion of the surgeon.
  • No allergies to iodinated contrast.
  • Diabetic patients will be eligible for this study. Patient on metformin will be asked not to take the drug for one day prior to and for two days after the procedure.
  • Subjects must be able to give informed consent

Exclusion Criteria:

  • Patients with an impaired kidney function, significantly elevated creatinine levels after angiography/PCI (serum creatinine level >1.5 mg/dl) will be excluded form the study.
  • Unstable patients or those with decompensated heart failure will be excluded because of safety reasons.
  • Pregnant or lactating women will be excluded. Pregnancy will need to be tested in all pre-menopausal women.
Sexes Eligible for Study: All
Ages 18 Years and older   (Adult, Older Adult)
Accepts Healthy Volunteers No
Contacts Contact information is only displayed when the study is recruiting subjects
Listed Location Countries United States
Removed Location Countries  
Administrative Information
NCT Number NCT00513773
Other Study ID Numbers 070535
LCIC Future Leaders in CV
Has Data Monitoring Committee No
U.S. FDA-regulated Product Not Provided
IPD Sharing Statement Not Provided
Current Responsible Party Vanderbilt University Medical Center
Original Responsible Party Not Provided
Current Study Sponsor Vanderbilt University Medical Center
Original Study Sponsor Vanderbilt University
Collaborators Not Provided
Principal Investigator: Uchechukwu Sampson, MD Vanderbilt University
PRS Account Vanderbilt University Medical Center
Verification Date April 2017