Aortic Aneurysm, AbdominalNCT00513773
Inflammation and Risk Prediction in Patients With Abdominal Aortic Aneurysm
An observational study of Aortic Aneurysm, Abdominal, run by Vanderbilt University Medical Center at 1 site in United States.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Aortic Aneurysm, Abdominal
- How many people
- 14 participants
- Where
- 1 siteUnited States
- Study dates
- Jul 2008to Feb 2014
- Phase
- Observational
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Study population: Patients with abdominal aortic aneurysm
Who may be able to join
- 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
Who cannot join
- 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.
Trial locations and contacts
1 site in 1 country.
United States1 site
Vanderbilt University Medical Center
Nashville, Tennessee, 37232-8802
About this study
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.
Read the 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.
- Conditions
- Aortic Aneurysm, Abdominal
- Keywords
- Abdominal Aortic Aneurysm,, Inflammation and Risk Prediction, Diagnostic Tool Efficacy
- Medical subject headings
- Aortic Aneurysm, Abdominal, Inflammation
What is being measured
The primary outcome is the main question the study is designed to answer.
Give more details that may enable us to better assess the chance of AAA expansion or rupture
Measured: 2 Years
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted9 Aug 2007 (estimated)
- Study startJul 2008
- Primary completionJul 2013
- Study completionFeb 2014
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Aortic Aneurysm, AbdominalStudies of the same condition, open and under way.
- More trials run by Vanderbilt University Medical CenterThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Cohort
- Time perspective
- Prospective
- Enrolment
- 14 participants (actual)
Sponsor and investigators
- Lead sponsor
- Vanderbilt University Medical Center
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Uchechukwu Sampson, MD, Principal investigator, Vanderbilt University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00513773
- Sponsor's protocol ID
- 070535
- Other IDs
- LCIC Future Leaders in CV
- Status last verified
- Apr 2017
- First submitted
- 8 Aug 2007
- Last updated
- 7 Apr 2017
- Results posted
- No
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 7 Apr 2017. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Inflammation and Risk Prediction in Patients With Abdominal Aortic Aneurysm
- ClinicalTrials.gov ID
- NCT00513773
- Acronym / sponsor ID
- 070535
- Conditions
- Aortic Aneurysm, Abdominal
- Keywords
- Abdominal Aortic Aneurysm,, Inflammation and Risk Prediction, Diagnostic Tool Efficacy
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 14 participants (actual)
- Lead sponsor
- Vanderbilt University Medical CenterUniversity, hospital or other
- Study start
- Jul 2008
- Primary completion
- Jul 2013 (actual)
- Study completion
- Feb 2014 (actual)
- First posted
- 9 Aug 2007 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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 design
- Observational model
- Cohort
- Time perspective
- Prospective
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- Patients with abdominal aortic aneurysm
Key inclusion criteria (5 listed)
- 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
Key exclusion criteria (3 listed)
- 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.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Primary outcome
Give more details that may enable us to better assess the chance of AAA expansion or rupture
Time frame: 2 Years
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 7 Apr 2017.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Uchechukwu Sampson, MD principal investigator
Vanderbilt University
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Aortic Aneurysm, Abdominal, run by Vanderbilt University Medical Center at 1 site in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 5 inclusion and 3 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 7 Apr 2017. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Give more details that may enable us to better assess the chance of AAA expansion or rupture (time frame: 2 Years). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 7 Apr 2017.