Abdominal Aortic AneurysmPhase 2NCT02022436
Evaluation of Predictors of Aortic Aneurysm Growth and Rupture
A Phase 2 study testing Contrast Ultrasound in people with Abdominal Aortic Aneurysm, run by Rabih A. Chaer at 1 site in United States.
Trial summary
The goal is to non-invasively study the metabolic processes within the aortic wall that are thought to explain progression to clinical manifestations of an aortic aneurysm. Hypothesis is that the non-invasive imaging of Abdominal Aortic Aneurysm (AAA) with contrast ultrasound, coupled with serum biomarker measurements… Read more about this study
- Who is it for?
- Ages 21 years and olderHealthy volunteers can take part
- Conditions the study is for
- Abdominal Aortic Aneurysm
- What is being tested?
- Contrast Ultrasound
- Type of treatment
- Injection or infusion
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 66 participants
- Where
- 1 siteUnited States
- Study dates
- May 2012to Feb 2022
- Phase
- Phase 2
- Are there results?
- Yes, posted in the registrySummary in the doctors' view
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 21 years and older
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- Diagnosis of AAA with confirmation of diagnosis of any size aneurysm with imaging.
- 21 years of age or older
- ability to give informed consent.
Who cannot join
- Inability to provide an informed consent
- Known allergy to Definity
- Unstable cardiopulmonary conditions
- pregnancy
Trial locations and contacts
1 site in 1 country.
United States1 site
University of Pittsburgh Medical Center, Division of Vascular Surgery
Pittsburgh, Pennsylvania, 15232
About this study
Official title: Aortic Wall Behavior as a Predictor of Aortic Aneurysm Growth and Rupture
The goal is to non-invasively study the metabolic processes within the aortic wall that are thought to explain progression to clinical manifestations of an aortic aneurysm.
Hypothesis is that the non-invasive imaging of Abdominal Aortic Aneurysm (AAA) with contrast ultrasound, coupled with serum biomarker measurements will allow the identification of the vulnerable aortic wall and patients who are at risk of AAA growth or rupture.
Read the detailed description
Aim#1: Prospective Contrast Ultrasound (CUS) imaging of patients with AAA to predict AAA growth and test gender differences in rate of growth and rupture.
Aim#2: Serum biomarker testing of patient with AAA. CUS findings will be correlated with serum biomarkers and AAA wall histology.
Prospective Contrast Ultrasound imaging of patients with AAA as part of a pilot feasibility study to predict AAA growth and test gender differences in rate of growth and rupture. CUS findings will be correlated with serum biomarkers and AAA wall histology. Potential significance: This study will evaluate the AAA wall and will be based on detecting areas of increased vasa vasorum density within the aneurysm wall and intraluminal thrombus, which indicate regional ischemia and inflammation of the aortic wall and propensity for weakening, enlargement or rupture. This novel evaluation of the aortic wall in patients with AAA will allow individualized treatment based on the biological potential for growth and rupture.
- Conditions
- Abdominal Aortic Aneurysm
- Being tested
- Contrast Ultrasound
- Medical subject headings
- Aortic Aneurysm, Abdominal
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Contrast UltrasoundDrug
Also called Definity
Definity® is the contrast agent that will be administered by intravenous injection by a registered nurse during the ultrasound (contrast enhanced ultrasound (CUS). The purpose is to assist in identifying differences in AAA characteristics based on gender and AAA stability and growth.
| Study group | Role | What they receive |
|---|---|---|
| contrast ultrasound for patients with AAA | Active comparator | Contrast ultrasound Receives: Drug: Contrast Ultrasound |
| contrast ultrasound for patients without arterial disease | Active comparator | contrast enhanced ultrasound Receives: Drug: Contrast Ultrasound |
What is being measured
The primary outcome is the main question the study is designed to answer.
Annual Aneurysm Growth Rate Between Patients With and Without Micro Bubble Uptake
Prospective contrast ultrasound will be performed at regular clinically indicated timepoints.
Measured: Up to 5 years or time of aneurysm repair surgery.
Number of Participants With Microbubble Uptake
Microbubble uptake was determined on ultrasound evaluation of the abdominal aorta. This was agreed upon by two reading physicians.
Measured: At the first follow-up evaluation at 6 months
Secondary outcomes (1)
Mean Value of Systemic Inflammatory Serum Biomarkers
Systemic serum biomarkers of AAA will be measured. These markers are circulating levels of C Reactive Protein, cytokines and osteoprotegerin.
Serum markers will be drawn at baseline and at the next follow-up visit which is 6 months after the index visit.
Measured: baseline, 6 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted27 Dec 2013 (estimated)
- Study startMay 2012
- Primary completionFeb 2022
- Study completionFeb 2022
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Posted resultsParticipant flow, outcome measures and adverse events reported by the sponsor.
- Other trials for Abdominal Aortic AneurysmStudies of the same condition, open and under way.
- 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
- Interventional
- Phase
- Phase 2
- Primary purpose
- Diagnosis
- Allocation
- Non-randomised
- Intervention model
- Crossover
- Masking
- None (open label)
- Enrolment
- 66 participants (actual)
Sponsor and investigators
- Lead sponsor
- Rabih A. Chaer
- Sponsor type
- University, hospital or other
- Collaborators
- National Institute on Aging (NIA)
- Responsible party
- Sponsor-investigator, Rabih A. Chaer, University of Pittsburgh
- Investigators
- Rabih Chaer, MD, Principal investigator, UPMC UPP
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02022436
- Sponsor's protocol ID
- AG042352-01
- Other IDs
- 1R03AG042352-01
- Status last verified
- Nov 2023
- First submitted
- 12 Dec 2013
- Last updated
- 13 Nov 2023
- Results posted
- Yes, on ClinicalTrials.gov
- Data monitoring committee
- Yes
- FDA-regulated drug
- Yes
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 13 Nov 2023. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Aortic Wall Behavior as a Predictor of Aortic Aneurysm Growth and Rupture
- ClinicalTrials.gov ID
- NCT02022436
- Acronym / sponsor ID
- AG042352-01
- Conditions
- Abdominal Aortic Aneurysm
- Phase
- Phase 2
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 66 participants (actual)
- Lead sponsor
- Rabih A. ChaerUniversity, hospital or other
- Collaborators
- National Institute on Aging (NIA)
- Study start
- May 2012 (actual)
- Primary completion
- Feb 2022 (actual)
- Study completion
- Feb 2022 (actual)
- First posted
- 27 Dec 2013 (estimated)
- Results
- Posted 13 Nov 2023
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
The goal is to non-invasively study the metabolic processes within the aortic wall that are thought to explain progression to clinical manifestations of an aortic aneurysm.
Hypothesis is that the non-invasive imaging of Abdominal Aortic Aneurysm (AAA) with contrast ultrasound, coupled with serum biomarker measurements will allow the identification of the vulnerable aortic wall and patients who are at risk of AAA growth or rupture.
Detailed description
Aim#1: Prospective Contrast Ultrasound (CUS) imaging of patients with AAA to predict AAA growth and test gender differences in rate of growth and rupture.
Aim#2: Serum biomarker testing of patient with AAA. CUS findings will be correlated with serum biomarkers and AAA wall histology.
Prospective Contrast Ultrasound imaging of patients with AAA as part of a pilot feasibility study to predict AAA growth and test gender differences in rate of growth and rupture. CUS findings will be correlated with serum biomarkers and AAA wall histology. Potential significance: This study will evaluate the AAA wall and will be based on detecting areas of increased vasa vasorum density within the aneurysm wall and intraluminal thrombus, which indicate regional ischemia and inflammation of the aortic wall and propensity for weakening, enlargement or rupture. This novel evaluation of the aortic wall in patients with AAA will allow individualized treatment based on the biological potential for growth and rupture.
Study design
- Primary purpose
- Diagnosis
- Allocation
- Non-randomised
- Intervention model
- Crossover
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| contrast ultrasound for patients with AAA | Active comparator | Drug: Contrast UltrasoundContrast ultrasound |
| contrast ultrasound for patients without arterial disease | Active comparator | Drug: Contrast Ultrasoundcontrast enhanced ultrasound |
Who may qualify
- Ages
- 21 years and older
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (3 listed)
- Diagnosis of AAA with confirmation of diagnosis of any size aneurysm with imaging.
- 21 years of age or older
- ability to give informed consent.
Key exclusion criteria (4 listed)
- Inability to provide an informed consent
- Known allergy to Definity
- Unstable cardiopulmonary conditions
- pregnancy
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Contrast UltrasoundAlso: DefinityDefinity® is the contrast agent that will be administered by intravenous injection by a registered nurse during the ultrasound (contrast enhanced ultrasound (CUS). The purpose is to assist in identifying differences in AAA characteristics based on gender and AAA stability and growth. | Drug | contrast ultrasound for patients with AAA, contrast ultrasound for patients without arterial disease |
Primary outcome
Annual Aneurysm Growth Rate Between Patients With and Without Micro Bubble Uptake
Time frame: Up to 5 years or time of aneurysm repair surgery.
Prospective contrast ultrasound will be performed at regular clinically indicated timepoints.
Number of Participants With Microbubble Uptake
Time frame: At the first follow-up evaluation at 6 months
Microbubble uptake was determined on ultrasound evaluation of the abdominal aorta. This was agreed upon by two reading physicians.
1 secondary outcome
Mean Value of Systemic Inflammatory Serum Biomarkers
Time frame: baseline, 6 months
Results and safety
Loading the posted results from ClinicalTrials.gov…
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 13 Nov 2023.
- Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
- Individual participant dataSharing planned: No
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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.
Rabih Chaer, MD principal investigator
UPMC UPP
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 2 study testing Contrast Ultrasound in people with Abdominal Aortic Aneurysm, run by Rabih A. Chaer 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 3 inclusion and 4 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 13 Nov 2023. 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.
What does this phase mean?
Phase 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
Yes. Results are posted in the registry (first posted 13 Nov 2023). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.
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?
Annual Aneurysm Growth Rate Between Patients With and Without Micro Bubble Uptake (time frame: Up to 5 years or time of aneurysm repair surgery.). The study lists 2 primary outcomes in all. 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 13 Nov 2023.