A Prospective Analysis on the Expansion Rates of Abdominal Aortic Aneurysms
| Status: | Enrolling by invitation |
|---|---|
| Conditions: | Cardiology, Cardiology, Cardiology |
| Therapuetic Areas: | Cardiology / Vascular Diseases |
| Healthy: | No |
| Age Range: | 21 - Any |
| Updated: | 11/9/2017 |
| Start Date: | September 2015 |
| End Date: | November 2018 |
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.
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.
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.
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.
Inclusion Criteria:
1. Over the age of 21 years.
2. Have been screened for abdominal aortic aneurysm by the VA or found to have an aorta
visualized from diagnostic imaging at least once.
3. Currently on no medications which would interfere with wound healing or compromise the
blood draw.
4. Not pregnant nor planning to become pregnant during study period.
5. No previous history of AAA repair.
Exclusion Criteria:
1. Failure to meet inclusion criteria.
2. Patient withdraws from the study.
3. In the opinion of the principle investigator, multiple comorbidities that make
analysis difficult.
We found this trial at
1
site
Click here to add this to my saved trials
