A Prospective Analysis on the Expansion Rates of Abdominal Aortic Aneurysms

November 27, 2019 updated by: VA Northern California Health Care System

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.

Study Overview

Status

Status

Indicates the current recruitment status or the expanded access status.
Unknown

Conditions

Conditions

The disease, disorder, syndrome, illness, or injury that is being studied. On ClinicalTrials.gov, conditions may also include other health-related issues, such as lifespan, quality of life, and health risks.

Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.

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 ≥ 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.

Study Type

Study Type

Describes the nature of a clinical study. Study types include interventional studies (also called clinical trials), observational studies (including patient registries), and expanded access.
Observational

Enrollment (Actual)

Enrollment

The number of participants in a clinical study. The "anticipated" enrollment is the target number of participants that the researchers need for the study.
150

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • United States
    • California
      • Mather, California, United States, 95655
        • Sacramento VA Medical Center

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Eligibility Criteria

The key requirements that people who want to participate in a clinical study must meet or the characteristics they must have. Eligibility criteria consist of both inclusion criteria (which are required for a person to participate in the study) and exclusion criteria (which prevent a person from participating). Types of eligibility criteria include whether a study accepts healthy volunteers, has age or age group requirements, or is limited by sex.

Ages Eligible for Study

21 years and older (Adult, Older Adult)

Accepts Healthy Volunteers

Yes

Genders Eligible for Study

All

Sampling Method

Non-Probability Sample

Study Population

Veterans of VA Northern California Health Care System

Description

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.

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

What is the study measuring?

Primary Outcome Measures

Primary Outcome Measures

In a clinical study's protocol, the planned outcome measure that is the most important for evaluating the effect of an intervention/treatment. Most clinical studies have one primary outcome measure, but some have more than one.
Outcome Measure
Measure Description
Time Frame
Aortic Expansion Rate
Time Frame: 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.
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 Outcome Measures

Secondary Outcome Measures

In a clinical study's protocol, a planned outcome measure that is not as important as the primary outcome measure for evaluating the effect of an intervention but is still of interest. Most clinical studies have more than one secondary outcome measure.
Outcome Measure
Measure Description
Time Frame
RhoA levels
Time Frame: From collection of blood to completion of blood analysis. This analysis takes 5-7 days to complete per patient.
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.

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Sponsor

The organization or person who initiates the study and who has authority and control over the study.
VA Northern California Health Care System

Collaborators

Collaborators

An organization other than the sponsor that provides support for a clinical study. This support may include activities related to funding, design, implementation, data analysis, or reporting.
Medtronic

Investigators

Investigators

A researcher involved in a clinical study. Related terms include site principal investigator, site sub-investigator, study chair, study director, and study principal investigator.
  • Principal Investigator: Eugene S Lee, MD, PhD, VA Northern California Health Care System

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

Study Start

The actual date on which the first participant was enrolled in a clinical study. The "anticipated" study start date is the date that the researchers think will be the study start date.
September 1, 2015

Primary Completion (Anticipated)

Primary Completion

The date on which the last participant in a clinical study was examined or received an intervention to collect final data for the primary outcome measure. Whether the clinical study ended according to the protocol or was terminated does not affect this date. For clinical studies with more than one primary outcome measure with different completion dates, this term refers to the date on which data collection is completed for all the primary outcome measures. The "anticipated" primary completion date is the date that the researchers think will be the primary completion date for the study.
September 1, 2020

Study Completion (Anticipated)

Study Completion

The date on which the last participant in a clinical study was examined or received an intervention/treatment to collect final data for the primary outcome measures, secondary outcome measures, and adverse events (that is, the last participant's last visit). The "anticipated" study completion date is the date that the researchers think will be the study completion date.
September 1, 2020

Study Registration Dates

First Submitted

First Submitted

The date on which the study sponsor or investigator first submitted a study record to ClinicalTrials.gov. There is typically a delay of a few days between the first submitted date and the record's availability on ClinicalTrials.gov (the first posted date).
October 6, 2015

First Submitted That Met QC Criteria

First Submitted That Met QC Criteria

The date on which the study sponsor or investigator first submits a study record that is consistent with National Library of Medicine (NLM) quality control (QC) review criteria. The sponsor or investigator may need to revise and submit a study record one or more times before NLM's QC review criteria are met. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
November 10, 2015

First Posted (Estimate)

First Posted

The date on which the study record was first available on ClinicalTrials.gov after National Library of Medicine (NLM) quality control (QC) review has concluded. There is typically a delay of a few days between the date the study sponsor or investigator submitted the study record and the first posted date.
November 13, 2015

Study Record Updates

Last Update Posted (Actual)

Last Update Posted

The most recent date on which changes to a study record were made available on ClinicalTrials.gov. There may be a delay between when the changes were submitted to ClinicalTrials.gov by the study's sponsor or investigator (the last update submitted date) and the last update posted date.
November 29, 2019

Last Update Submitted That Met QC Criteria

Last Update Submitted That Met QC Criteria

The most recent date on which the study sponsor or investigator submitted changes to a study record that are consistent with National Library of Medicine (NLM) quality control (QC) review criteria. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
November 27, 2019

Last Verified

Last Verified

The most recent date on which the study sponsor or investigator confirmed the information about a clinical study on ClinicalTrials.gov as accurate and current. If a study with a recruitment status of recruiting; not yet recruiting; or active, not recruiting has not been confirmed within the past 2 years, the study's recruitment status is shown as unknown.
November 1, 2019

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

Other Study ID Numbers

Identifiers or ID numbers other than the NCT number that are assigned to a clinical study by the study's sponsor, funders, or others. These numbers may include unique identifiers from other trial registries and National Institutes of Health grant numbers.
  • Medtronic A1231656

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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