Abdominal Aortic AneurysmNCT02604303
A Prospective Analysis on the Expansion Rates of Abdominal Aortic Aneurysms
An observational study of Abdominal Aortic Aneurysm, run by VA Northern California Health Care System at 1 site in United States.
Trial summary
Abdominal aortic aneurysm (AAA) disease is an abnormal bulging of the main abdominal artery, which is the called the abdominal aorta. The purpose of this observational study is to identify whether a blood biomarker protein RhoA can predict which small AAA patients may need surgery in the future. 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
- How many people
- 150 participants
- Where
- 1 siteUnited States
- Study dates
- Sep 2015to Sep 2020
- 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 21 years and older
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Study population: Veterans of VA Northern California Health Care System
Who may be able to join
- Over the age of 21 years.
- Have been screened for abdominal aortic aneurysm by the VA or found to have an aorta visualized from diagnostic imaging at least once.
- Currently on no medications which would interfere with wound healing or compromise the blood draw.
- Not pregnant nor planning to become pregnant during study period.
- No previous history of AAA repair.
Who cannot join
- Failure to meet inclusion criteria.
- Patient withdraws from the study.
- In the opinion of the principle investigator, multiple comorbidities that make analysis difficult.
Trial locations and contacts
1 site in 1 country.
United States1 site
Sacramento VA Medical Center
Mather, California, 95655
About this study
Abdominal aortic aneurysm (AAA) disease is an abnormal bulging of the main abdominal artery, which is the called the abdominal aorta. The purpose of this observational study is to identify whether a blood biomarker protein RhoA can predict which small AAA patients may need surgery in the future.
Participating patients will receive an ultrasound and blood draw. The patients will be divided into expanding and stable aorta groups after determining each patient's aortic expansion rate. The blood RhoA levels and aortic expansion rates between both groups would then be compared to look for any relationships.
Read the detailed description
Abdominal aortic aneurysm (AAA) is an asymptomatic problem until rupture occurs, causing excruciating pain and sudden death. It is diagnosed typically by ultrasound when the aortic diameter is ≥ 3.0 cm and an aortic diameter ≥ 5.5 cm generally requires surgical repair to prevent rupture. A normal aorta is 2.0 cm in diameter. For patients with small AAA (3.0-5.4 cm) serial imaging studies is recommended along with risk factor modification. However, follow up ultrasound protocols are difficult to follow, resulting in many patients with expanding AAA not being detected until too late. To streamline and better identify patients with small AAAs at risk for expansion, the investigators look to RhoA as a possible biomarker.
The investigators will recruit within a 3-year period a total of 200 subjects diagnosed with small AAA 3.0-5.4 cm diameter from the VA Northern California Health Care System. All subjects enrolled will already have a baseline aortic diameter established at the time of initial AAA screening or diagnostic imaging. The investigators expect the follow up ultrasound measurement for this study will be at least 1 to 5 years after their baseline ultrasound study. The follow up evaluation will then assess expansion rates of the aorta. Stable aorta subjects will have an expansion rate of less than 0.2 cm/year and expanding aorta subjects will have an expansion rate ≥ 0.2 cm/year as based on preliminary data. After the ultrasound, 30 ml of blood will be drawn into heparinized tubes and undergo blood analysis for the RhoA protein in monocytes. All patients will be notified of the possible need to return back for either clinical reason: AAA greater than 5.5 cm or research protocol reasons: inadequate monocyte collection or changing clinical data requirements. Cardiovascular risk factors will also be collected. All collected data between stable and expanding AAA groups will then be compared for analysis.
If biological or clinical risk factors are identified as reliable biomarkers for AAA expansion, then AAA screening programs could be modified to increase screening yield and improve surveillance for small AAAs. Additionally, novel diagnostic techniques could be developed to better identify small AAA patients at risk for surgery.
- Conditions
- Abdominal Aortic Aneurysm
- Being tested
- No Intervention
- Keywords
- Abdominal Aortic Aneurysm, RhoA, Biomarker
- 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.
No InterventionOther
No intervention; prospective observational study
What is being measured
The primary outcome is the main question the study is designed to answer.
Aortic Expansion Rate
Aortic expansion rate (cm/yr) is calculated by taking the difference of aortic growth (cm) divided by the number of days between a patient's screening date and the study date. This rate is then converted into cm/yr.
Measured: Immediately after study ultrasound for each subject. The aortic expansion rate is immediately obtained once the study ultrasound measurement of the aortic diameter is verified.
Secondary outcomes (1)
RhoA levels
RhoA levels measured in fluorescent units from patient monocytes will be determined
Measured: From collection of blood to completion of blood analysis. This analysis takes 5-7 days to complete per patient.
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted13 Nov 2015 (estimated)
- Study startSep 2015
- Primary completionSep 2020 (estimated)
- Study completionSep 2020 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- 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
- Observational
- Observational model
- Cohort
- Time perspective
- Prospective
- Enrolment
- 150 participants (actual)
Sponsor and investigators
- Lead sponsor
- VA Northern California Health Care System
- Sponsor type
- US federal agency
- Collaborators
- Medtronic
- Responsible party
- Sponsor
- Investigators
- Eugene S Lee, MD, PhD, Principal investigator, VA Northern California Health Care System
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02604303
- Sponsor's protocol ID
- Medtronic A1231656
- Status last verified
- Nov 2019
- First submitted
- 6 Oct 2015
- Last updated
- 29 Nov 2019
- Results posted
- No
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 29 Nov 2019. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Prospective Analysis on the Expansion Rates of Abdominal Aortic Aneurysms
- ClinicalTrials.gov ID
- NCT02604303
- Acronym / sponsor ID
- Medtronic A1231656
- Conditions
- Abdominal Aortic Aneurysm
- Keywords
- Abdominal Aortic Aneurysm, RhoA, Biomarker
- Study type
- Observational
- Recruitment status
- Unknown status
- Enrolment
- 150 participants (actual)
- Lead sponsor
- VA Northern California Health Care SystemUS federal agency
- Collaborators
- Medtronic
- Study start
- Sep 2015
- Primary completion
- Sep 2020 (estimated)
- Study completion
- Sep 2020 (estimated)
- First posted
- 13 Nov 2015 (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.
Abdominal aortic aneurysm (AAA) disease is an abnormal bulging of the main abdominal artery, which is the called the abdominal aorta. The purpose of this observational study is to identify whether a blood biomarker protein RhoA can predict which small AAA patients may need surgery in the future.
Participating patients will receive an ultrasound and blood draw. The patients will be divided into expanding and stable aorta groups after determining each patient's aortic expansion rate. The blood RhoA levels and aortic expansion rates between both groups would then be compared to look for any relationships.
Detailed description
Abdominal aortic aneurysm (AAA) is an asymptomatic problem until rupture occurs, causing excruciating pain and sudden death. It is diagnosed typically by ultrasound when the aortic diameter is ≥ 3.0 cm and an aortic diameter ≥ 5.5 cm generally requires surgical repair to prevent rupture. A normal aorta is 2.0 cm in diameter. For patients with small AAA (3.0-5.4 cm) serial imaging studies is recommended along with risk factor modification. However, follow up ultrasound protocols are difficult to follow, resulting in many patients with expanding AAA not being detected until too late. To streamline and better identify patients with small AAAs at risk for expansion, the investigators look to RhoA as a possible biomarker.
The investigators will recruit within a 3-year period a total of 200 subjects diagnosed with small AAA 3.0-5.4 cm diameter from the VA Northern California Health Care System. All subjects enrolled will already have a baseline aortic diameter established at the time of initial AAA screening or diagnostic imaging. The investigators expect the follow up ultrasound measurement for this study will be at least 1 to 5 years after their baseline ultrasound study. The follow up evaluation will then assess expansion rates of the aorta. Stable aorta subjects will have an expansion rate of less than 0.2 cm/year and expanding aorta subjects will have an expansion rate ≥ 0.2 cm/year as based on preliminary data. After the ultrasound, 30 ml of blood will be drawn into heparinized tubes and undergo blood analysis for the RhoA protein in monocytes. All patients will be notified of the possible need to return back for either clinical reason: AAA greater than 5.5 cm or research protocol reasons: inadequate monocyte collection or changing clinical data requirements. Cardiovascular risk factors will also be collected. All collected data between stable and expanding AAA groups will then be compared for analysis.
If biological or clinical risk factors are identified as reliable biomarkers for AAA expansion, then AAA screening programs could be modified to increase screening yield and improve surveillance for small AAAs. Additionally, novel diagnostic techniques could be developed to better identify small AAA patients at risk for surgery.
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
Who may qualify
- Ages
- 21 years and older
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
- Study population
- Veterans of VA Northern California Health Care System
Key inclusion criteria (5 listed)
- Over the age of 21 years.
- Have been screened for abdominal aortic aneurysm by the VA or found to have an aorta visualized from diagnostic imaging at least once.
- Currently on no medications which would interfere with wound healing or compromise the blood draw.
- Not pregnant nor planning to become pregnant during study period.
- No previous history of AAA repair.
Key exclusion criteria (3 listed)
- Failure to meet inclusion criteria.
- Patient withdraws from the study.
- In the opinion of the principle investigator, multiple comorbidities that make analysis difficult.
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 |
|---|---|---|
| No InterventionNo intervention; prospective observational study | Other | – |
Primary outcome
Aortic Expansion Rate
Time frame: Immediately after study ultrasound for each subject. The aortic expansion rate is immediately obtained once the study ultrasound measurement of the aortic diameter is verified.
Aortic expansion rate (cm/yr) is calculated by taking the difference of aortic growth (cm) divided by the number of days between a patient's screening date and the study date. This rate is then converted into cm/yr.
1 secondary outcome
RhoA levels
Time frame: From collection of blood to completion of blood analysis. This analysis takes 5-7 days to complete per patient.
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 29 Nov 2019.
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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.
Eugene S Lee, MD, PhD principal investigator
VA Northern California Health Care System
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 Abdominal Aortic Aneurysm, run by VA Northern California Health Care System 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: status not confirmed, as of the sponsor's last update on 29 Nov 2019. 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?
Results are not available in the source record.
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?
Aortic Expansion Rate (time frame: Immediately after study ultrasound for each subject. The aortic expansion rate is immediately obtained once the study ultrasound measurement of the aortic diameter is verified.). 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 29 Nov 2019.