UVA Brain and Aortic Aneurysm Study

Brief Title

UVA Brain and Aortic Aneurysm Study

Official Title

The University of Virginia Brain and Aortic Aneurysm Study

Brief Summary

      The purpose of this study is to examine the percentage of patients who present with abdominal
      aortic aneurysms (AAA) will also have intracranial aneurysms (IA) and conversely; to examine
      the percentage of patients who present with intracranial aneurysms will also have abdominal
      aortic aneurysms.
    

Detailed Description

      The investigators have previously generated estimates for cost effectiveness of each arm of
      this reciprocal screening protocol based on literature dervied estimates of coprevalence and
      other key factors in a decision tree model to compare costs and outcomes. They measured
      expected outcomes using quality-adjusted life years (QALY) and the incremental
      cost-effectiveness ratios (ICER). The current study will involve establishment of the true
      co-prevalence and recalculation of the ICERs and QALYs. Based on their literature derived
      models we previously found an ICER of $34.01/QALY for AAA screening in IA patients and an
      ICER of $6,401.91/QALY for IA screening in AAA patients. Both of these are well below the
      societal accepted threshold of $60,000/QALY. However, both models were sensitive to
      co-prevalence. In the current study the investigators will therefore determine the actual
      cost-effectiveness of performing additional radiographic procedures and genetic counseling.
      The investigators will also bank DNA and RNA for future research.
    

Study Type

Observational [Patient Registry]

Primary Outcome

Revised cost-effective analysis measured in dollars/quality adjusted life years (QALY)

Secondary Outcome

 Analysis of Covariates for co-prevalence of aneurysms measured as present or absent

Condition

Intracranial Aneurysm

Intervention

Imaging-Ultrasound

Study Arms / Comparison Groups

 Patients presenting with IA

Description:  These patients will undergo an abdominal ultrasound (Imaging - Ultrasound) to test for abdominal aortic aneurysm(s). RNA, DNA testing will be planned on banked samples

Publications

* Includes publications given by the data provider as well as publications identified by National Clinical Trials Identifier (NCT ID) in Medline.

Recruitment Status

Other

Estimated Enrollment

360

Start Date

April 2014

Primary Completion Date

April 2017

Eligibility Criteria

        Inclusion Criteria:

          -  Age 18 years or older

          -  Clinical and radiographic diagnosis of either abdominal aortic aneurysm (AAA) or
             intracranial cerebral aneurysm (IA). Aneurysm may be symptomatic (s/p rupture or mass
             effect) or asymptomatic (detected as part of screening or incidentally discovered.
             Aneurysms int he brain may be multiple. AAA will be defined as >= 3 cm by any imaging
             modality. IA will be defined as >= 3 mm on any imaging modality.

          -  Able to provide a valid informed consent (self or legally authorized representative)

        Exclusion Criteria:

          -  Contra-indication for MRI/A (embedded metal, intractable claustrophobia, pacemaker,
             etc.)

          -  Intracranial aneurysm associated with arteriovenous malformation

          -  Clinical or radiographic diagnosis of mycotic aneurysm

          -  Substantial pre-existing neurological or psychiatric illness that would confound
             neurological assessment or other outcome assessment.

          -  Other serious conditions that make the patient unlikely to survive long enough to
             benefit from the screening program.

          -  Inability to follow the protocol or return for screening test or genetic counseling.

          -  Unwilling to have reports from imaging and genetic counselor sent to a clinician (PCP,
             testing surgeon, etc)

        Note: Pregnancy is not a reason to exclude, but imaging done for the study will be
        postponed until after the subject has given birth.
      

Gender

All

Ages

18 Years - N/A

Accepts Healthy Volunteers

No

Contacts

Bradford B Worrall, MD, MSc, 434-924-9271, [email protected]

Location Countries

United States

Location Countries

United States

NCT ID

NCT02869464

Organization ID

17341

Responsible Party

Principal Investigator

Study Sponsor

University of Virginia

Study Sponsor

Bradford B Worrall, MD, MSc, Principal Investigator, University of Virginia

Verification Date

August 2016