Inflammation and Risk Prediction in Patients With Abdominal Aortic Aneurysm

April 5, 2017 updated by: Vanderbilt University Medical Center
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.

Study Overview

Status

Status

Indicates the current recruitment status or the expanded access status.
Completed

Conditions

Conditions

The disease, disorder, syndrome, illness, or injury that is being studied. On ClinicalTrials.gov, conditions may also include other health-related issues, such as lifespan, quality of life, and health risks.

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

Study Type

Describes the nature of a clinical study. Study types include interventional studies (also called clinical trials), observational studies (including patient registries), and expanded access.
Observational

Enrollment (Actual)

Enrollment

The number of participants in a clinical study. The "anticipated" enrollment is the target number of participants that the researchers need for the study.
14

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • United States
    • Tennessee
      • Nashville, Tennessee, United States, 37232-8802
        • Vanderbilt University Medical Center

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Eligibility Criteria

The key requirements that people who want to participate in a clinical study must meet or the characteristics they must have. Eligibility criteria consist of both inclusion criteria (which are required for a person to participate in the study) and exclusion criteria (which prevent a person from participating). Types of eligibility criteria include whether a study accepts healthy volunteers, has age or age group requirements, or is limited by sex.

Ages Eligible for Study

18 years and older (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Sampling Method

Non-Probability Sample

Study Population

Patients with abdominal aortic aneurysm

Description

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.

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

What is the study measuring?

Primary Outcome Measures

Primary Outcome Measures

In a clinical study's protocol, the planned outcome measure that is the most important for evaluating the effect of an intervention/treatment. Most clinical studies have one primary outcome measure, but some have more than one.
Outcome Measure
Time Frame
Give more details that may enable us to better assess the chance of AAA expansion or rupture
Time Frame: 2 Years
2 Years

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Sponsor

The organization or person who initiates the study and who has authority and control over the study.
Vanderbilt University Medical Center

Investigators

Investigators

A researcher involved in a clinical study. Related terms include site principal investigator, site sub-investigator, study chair, study director, and study principal investigator.
  • Principal Investigator: Uchechukwu Sampson, MD, Vanderbilt University

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

Study Start

The actual date on which the first participant was enrolled in a clinical study. The "anticipated" study start date is the date that the researchers think will be the study start date.
July 1, 2008

Primary Completion (Actual)

Primary Completion

The date on which the last participant in a clinical study was examined or received an intervention to collect final data for the primary outcome measure. Whether the clinical study ended according to the protocol or was terminated does not affect this date. For clinical studies with more than one primary outcome measure with different completion dates, this term refers to the date on which data collection is completed for all the primary outcome measures. The "anticipated" primary completion date is the date that the researchers think will be the primary completion date for the study.
July 1, 2013

Study Completion (Actual)

Study Completion

The date on which the last participant in a clinical study was examined or received an intervention/treatment to collect final data for the primary outcome measures, secondary outcome measures, and adverse events (that is, the last participant's last visit). The "anticipated" study completion date is the date that the researchers think will be the study completion date.
February 1, 2014

Study Registration Dates

First Submitted

First Submitted

The date on which the study sponsor or investigator first submitted a study record to ClinicalTrials.gov. There is typically a delay of a few days between the first submitted date and the record's availability on ClinicalTrials.gov (the first posted date).
August 8, 2007

First Submitted That Met QC Criteria

First Submitted That Met QC Criteria

The date on which the study sponsor or investigator first submits a study record that is consistent with National Library of Medicine (NLM) quality control (QC) review criteria. The sponsor or investigator may need to revise and submit a study record one or more times before NLM's QC review criteria are met. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
August 8, 2007

First Posted (Estimate)

First Posted

The date on which the study record was first available on ClinicalTrials.gov after National Library of Medicine (NLM) quality control (QC) review has concluded. There is typically a delay of a few days between the date the study sponsor or investigator submitted the study record and the first posted date.
August 9, 2007

Study Record Updates

Last Update Posted (Actual)

Last Update Posted

The most recent date on which changes to a study record were made available on ClinicalTrials.gov. There may be a delay between when the changes were submitted to ClinicalTrials.gov by the study's sponsor or investigator (the last update submitted date) and the last update posted date.
April 7, 2017

Last Update Submitted That Met QC Criteria

Last Update Submitted That Met QC Criteria

The most recent date on which the study sponsor or investigator submitted changes to a study record that are consistent with National Library of Medicine (NLM) quality control (QC) review criteria. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
April 5, 2017

Last Verified

Last Verified

The most recent date on which the study sponsor or investigator confirmed the information about a clinical study on ClinicalTrials.gov as accurate and current. If a study with a recruitment status of recruiting; not yet recruiting; or active, not recruiting has not been confirmed within the past 2 years, the study's recruitment status is shown as unknown.
April 1, 2017

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

Other Study ID Numbers

Identifiers or ID numbers other than the NCT number that are assigned to a clinical study by the study's sponsor, funders, or others. These numbers may include unique identifiers from other trial registries and National Institutes of Health grant numbers.
  • 070535
  • LCIC Future Leaders in CV

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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