Abdominal Aortic Aneurysm Clinical Trial
Official title:
A Prospective Analysis on the Expansion Rates of Abdominal Aortic Aneurysms
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.
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.
;
Status | Clinical Trial | Phase | |
---|---|---|---|
Active, not recruiting |
NCT04227054 -
Abdominal Aortic Aneurysm Sac Healing and Prevention of Endoleaks
|
N/A | |
Active, not recruiting |
NCT03687489 -
Safety and Efficacy Study of Abdominal Aortic Aneurysm Stent Graft System
|
N/A | |
Active, not recruiting |
NCT03507413 -
Metformin Therapy in Non-diabetic AAA Patients
|
Phase 2/Phase 3 | |
Not yet recruiting |
NCT05756283 -
The PREHAAAB Trial: Multimodal Prehabilitation for Patients Awaiting Open Abdominal Aortic Aneurysm Repair
|
N/A | |
Not yet recruiting |
NCT04089241 -
Fusion of CT Angiography With 3D Contrast Ultrasound as a Method for Follow up for Endovascular Aneurysm Repair
|
N/A | |
Terminated |
NCT01843335 -
Contrast-enhanced Ultrasound in Follow-up After Endovascular Aneurysm Repair
|
N/A | |
Completed |
NCT02229006 -
Sodium Fluoride Imaging of Abdominal Aortic Aneurysms
|
N/A | |
Completed |
NCT02224794 -
LIFE Study: Least Invasive Fast-Track EVAR
|
||
Terminated |
NCT02469376 -
Evaluation of a New Imagingtechnologie for Thrombosis
|
Phase 1 | |
Completed |
NCT01118520 -
AARDVARK (Aortic Aneurysmal Regression of Dilation: Value of ACE-Inhibition on RisK)
|
Phase 2 | |
Terminated |
NCT01425242 -
Study on Anti-inflammatory Effect of Anti-hypertensive Treatment in Patients With Small AAA's and Mild Hypertension
|
N/A | |
Completed |
NCT00746122 -
Immediate Management of the Patient With Rupture : Open Versus Endovascular Repair
|
N/A | |
Completed |
NCT03952780 -
Korean Registry of Percutaneous EVAR With INCRAFT Stent Graft for the Treatment of Abdominalaortic Aneurysm (K-INCRAFT)
|
||
Completed |
NCT00583414 -
Endovascular Exclusion of Abdominal Aortic Aneurysms in High Risk Patients
|
N/A | |
Recruiting |
NCT05864560 -
Ankura™ AAA, Cuff and AUI Stent Graft System Post-Market Clinical Follow-Up
|
||
Completed |
NCT01683084 -
Study of the Effectiveness of Telmisartan in Slowing the Progression of Abdominal Aortic Aneurysms
|
Phase 4 | |
Active, not recruiting |
NCT03180996 -
Global Fenestrated Anaconda Clinical sTudy
|
||
Completed |
NCT02493296 -
The Effect of Surgery on Central Aortic Pressure & haEmodynamics Study
|
||
Completed |
NCT03320408 -
Predicting Aneurysm Growth and Rupture With Longitudinal Biomarkers
|
||
Completed |
NCT03837704 -
Comparison of Abdominal Aortic Aneurysm Growth in Adult Smoking Patients Who Either Switch to IQOS, Continue Smoking, or Quit Smoking.
|
N/A |