Inflammation and Risk Prediction in Patients With Abdominal Aortic Aneurysm

The recruitment status of this study is unknown because the information has not been verified recently.
Verified July 2011 by Vanderbilt University.
Recruitment status was  Recruiting
Sponsor:
Information provided by:
Vanderbilt University
ClinicalTrials.gov Identifier:
NCT00513773
First received: August 8, 2007
Last updated: July 25, 2011
Last verified: July 2011
  Purpose

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.


Condition Phase
Aortic Aneurysm, Abdominal
Phase 2

Study Type: Observational
Study Design: Observational Model: Cohort
Time Perspective: Prospective
Official Title: Inflammation and Risk Prediction in Patients With Abdominal Aortic Aneurysm

Resource links provided by NLM:


Further study details as provided by Vanderbilt University:

Primary Outcome Measures:
  • Give more details that may enable us to better assess the chance of AAA expansion or rupture [ Time Frame: 2 Years ] [ Designated as safety issue: No ]

Biospecimen Retention:   Samples With DNA

Serum/plasma for biomarker analysis


Estimated Enrollment: 30
Study Start Date: July 2008
Estimated Study Completion Date: July 2013
Estimated Primary Completion Date: July 2013 (Final data collection date for primary outcome measure)
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.

  Eligibility

Ages Eligible for Study:   18 Years and older
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Sampling Method:   Non-Probability Sample
Study Population

Patients with abdominal aortic aneurysm

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.
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT00513773

Contacts
Contact: Terri Herrud, BS, CCRP 615 343 6426 terri.herrud@vanderbilt.edu

Locations
United States, Tennessee
Vanderbilt University Medical Center Recruiting
Nashville, Tennessee, United States, 37232-8802
Contact: Terri Herrud, BS, CCRP    615-343-6426    terri.herrud@vanderbilt.edu   
Sub-Investigator: Marvin Kronenberg, MD         
Sub-Investigator: William H Martin, MD         
Sub-Investigator: Raul J Guzman, MD         
Sub-Investigator: Douglas E Vaughan, MD         
Sub-Investigator: Thomas C Naslund, MD         
Sub-Investigator: MacRae Linton, MD         
Sub-Investigator: Sergio Fazio, MD, PHD         
Sub-Investigator: Ronald Walker, MD         
Sub-Investigator: Dominique Delbeke, MD         
Sub-Investigator: John Patton, MD         
Sponsors and Collaborators
Vanderbilt University
Investigators
Principal Investigator: Uchechukwu Sampson, MD Vanderbilt University
  More Information

No publications provided

Responsible Party: Uchechukwu K. A. Sampson, M.B., B.S., MBA, M.P.H., M.Sc, Vanderbilt University
ClinicalTrials.gov Identifier: NCT00513773     History of Changes
Other Study ID Numbers: 070535, LCIC Future Leaders in CV
Study First Received: August 8, 2007
Last Updated: July 25, 2011
Health Authority: United States: Institutional Review Board

Keywords provided by Vanderbilt University:
Abdominal Aortic Aneurysm,
Inflammation and Risk Prediction
Diagnostic Tool Efficacy

Additional relevant MeSH terms:
Inflammation
Aortic Aneurysm
Aneurysm
Aortic Aneurysm, Abdominal
Pathologic Processes
Vascular Diseases
Cardiovascular Diseases
Aortic Diseases

ClinicalTrials.gov processed this record on September 22, 2014