Abdominal Aortic Aneurysm Clinical Trial
Official title:
A Prospective Analysis on the Expansion Rates of Abdominal Aortic Aneurysms
Verified date | November 2019 |
Source | VA Northern California Health Care System |
Contact | n/a |
Is FDA regulated | No |
Health authority | |
Study type | Observational |
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.
Status | Active, not recruiting |
Enrollment | 150 |
Est. completion date | September 2020 |
Est. primary completion date | September 2020 |
Accepts healthy volunteers | Accepts Healthy Volunteers |
Gender | All |
Age group | 21 Years and older |
Eligibility |
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. |
Country | Name | City | State |
---|---|---|---|
United States | Sacramento VA Medical Center | Mather | California |
Lead Sponsor | Collaborator |
---|---|
VA Northern California Health Care System | Medtronic |
United States,
Type | Measure | Description | Time frame | Safety issue |
---|---|---|---|---|
Primary | 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. | 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 | RhoA levels | RhoA levels measured in fluorescent units from patient monocytes will be determined | From collection of blood to completion of blood analysis. This analysis takes 5-7 days to complete per patient. |
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