A Prospective Analysis on the Expansion Rates of Abdominal Aortic Aneurysms

NCT02604303 | Unknown

• 1 other identifier: Medtronic A1231656
• Study Type: observational
• Target: 150
• Locations: 1 country
• Sites: 1

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 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.

Conditions

Abdominal Aortic Aneurysm

Keywords

Abdominal Aortic Aneurysm; RhoA; Biomarker

Outcome Measures

Primary Outcomes (1)

• 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 Outcomes (1)

• RhoA levels

  From collection of blood to completion of blood analysis. This analysis takes 5-7 days to complete per patient.

Interventions

No Intervention OTHER

No intervention; prospective observational study

Eligibility Criteria

• Age: 21 Years+
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)
• Sampling Method: Non-Probability Sample

Study Population

Veterans of VA Northern California Health Care System

You may qualify if:

• 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.

You may not qualify if:

• Patient withdraws from the study.
• In the opinion of the principle investigator, multiple comorbidities that make analysis difficult.

Sponsors & Collaborators

• VA Northern California Health Care System: lead
• Medtronic: collaborator

Study Sites (1)

Sacramento VA Medical Center

Mather, California, 95655, United States

Location

Biospecimen

Retention: SAMPLES WITH DNA

Patient monocytes from peripheral blood

MeSH Terms

Conditions

Aortic Aneurysm, Abdominal

Condition Hierarchy (Ancestors)

Aortic Aneurysm; Aneurysm; Vascular Diseases; Cardiovascular Diseases; Aortic Diseases

Study Officials

• Eugene S Lee, MD, PhD

  VA Northern California Health Care System

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: PROSPECTIVE
• Sponsor Type: FED
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: October 6, 2015
• First Posted: November 13, 2015
• Study Start: September 1, 2015
• Primary Completion: September 1, 2020
• Study Completion: September 1, 2020
• Last Updated: November 29, 2019

Record last verified: 2019-11

Locations

US (1)