NCT00513773

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.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
14

participants targeted

Target at below P25 for all trials

Timeline
Completed

Started Jul 2008

Longer than P75 for all trials

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

August 8, 2007

Completed
1 day until next milestone

First Posted

Study publicly available on registry

August 9, 2007

Completed
11 months until next milestone

Study Start

First participant enrolled

July 1, 2008

Completed
5 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

July 1, 2013

Completed
7 months until next milestone

Study Completion

Last participant's last visit for all outcomes

February 1, 2014

Completed
Last Updated

April 7, 2017

Status Verified

April 1, 2017

Enrollment Period

5 years

First QC Date

August 8, 2007

Last Update Submit

April 5, 2017

Conditions

Aortic Aneurysm, Abdominal

Keywords

Abdominal Aortic Aneurysm,Inflammation and Risk PredictionDiagnostic Tool Efficacy

Outcome Measures

Primary Outcomes (1)

  • Give more details that may enable us to better assess the chance of AAA expansion or rupture

    2 Years

Eligibility Criteria

Age18 Years+
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)
Sampling MethodNon-Probability Sample
Study Population

Patients with abdominal aortic aneurysm

You may qualify if:

  • 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

You may not qualify if:

  • 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.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Vanderbilt University Medical Center

Nashville, Tennessee, 37232-8802, United States

Location

Biospecimen

Retention: SAMPLES WITH DNA

Serum/plasma for biomarker analysis

MeSH Terms

Conditions

Aortic Aneurysm, AbdominalInflammation

Condition Hierarchy (Ancestors)

Aortic AneurysmAneurysmVascular DiseasesCardiovascular DiseasesAortic DiseasesPathologic ProcessesPathological Conditions, Signs and Symptoms

Study Officials

  • Uchechukwu Sampson, MD

    Vanderbilt University

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
observational
Observational Model
COHORT
Time Perspective
PROSPECTIVE
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

August 8, 2007

First Posted

August 9, 2007

Study Start

July 1, 2008

Primary Completion

July 1, 2013

Study Completion

February 1, 2014

Last Updated

April 7, 2017

Record last verified: 2017-04

Locations

US(1)