Ignite Creation Date:
2024-05-06 @ 7:49 AM
Last Modification Date:
2024-10-26 @ 11:52 AM
Study NCT ID:
NCT02604303
Status:
UNKNOWN
Last Update Posted:
2019-11-29
First Post:
2015-10-06
Brief Title:
A Prospective Analysis on the Expansion Rates of Abdominal Aortic Aneurysms
Sponsor:
VA Northern California Health Care System
Organization:
VA Northern California Health Care System
Study Overview
Official Title:
A Prospective Analysis on the Expansion Rates of Abdominal Aortic Aneurysms
Status:
UNKNOWN
Status Verified Date:
2019-11
Last Known Status:
ACTIVE_NOT_RECRUITING
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
None
Brief 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
Participating patients will receive an ultrasound and blood draw The patients will be divided into expanding and stable aorta groups after determining each patients aortic expansion rate The blood RhoA levels and aortic expansion rates between both groups would then be compared to look for any relationships
Participating patients will receive an ultrasound and blood draw The patients will be divided into expanding and stable aorta groups after determining each patients 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 30 cm and an aortic diameter 55 cm generally requires surgical repair to prevent rupture A normal aorta is 20 cm in diameter For patients with small AAA 30-54 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 30-54 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 02 cmyear and expanding aorta subjects will have an expansion rate 02 cmyear 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 55 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
The investigators will recruit within a 3-year period a total of 200 subjects diagnosed with small AAA 30-54 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 02 cmyear and expanding aorta subjects will have an expansion rate 02 cmyear 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 55 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 Oversight
Has Oversight DMC:
None
Is a FDA Regulated Drug?:
None
Is a FDA Regulated Device?:
None
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?:
None