UVA Brain and Aortic Aneurysm Study (BAAS)

The University of Virginia Brain and Aortic Aneurysm Study

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.

Study Overview

• Status: Unknown
• Conditions: Intracranial Aneurysm; Abdominal Aortic Aneurysm
• Intervention / Treatment: Other: Imaging-Ultrasound; Genetic: DNA, RNA testing; Other: Imaging-MRA

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
• Enrollment (Anticipated): 360

Contacts and Locations

• Study Contact: Name: Claire L McKinley, C.C.R.P.; Phone Number: 434-924-9271; Email: cw9ne@hscmail.mcc.virginia.edu
• Study Contact Backup: Name: Julia Krupa, M.S.; Phone Number: 434-924-4023; Email: jkk8d@virginia.edu

Study Locations

• United States
  • Virginia
    • Charlottesville, Virginia, United States, 22903
      • Recruiting
      • University Of Virginia
      • Contact: Claire L McKinley, C.C.R.P.; Phone Number: 434-924-9271; Email: cw9ne@virginia.edu
      • Contact: Julia K Krupa, M.S.; Phone Number: 434-924-4023; Email: jkk8d@virginia.edu
      • Principal Investigator: Bradford B Worrall, M.D.

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

• Sampling Method: Non-Probability Sample

Study Population

Patients who have been diagnosed with either a IA or AAA.

Description

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.

Study Plan

How is the study designed?

Number of groups / cohorts

2

Cohorts and Interventions

Group / Cohort	Intervention / Treatment
Patients presenting with IA; 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	Other: Imaging-Ultrasound; Abdominal Ultrasound; Genetic: DNA, RNA testing; To test for the co-prevalence of shared genetic markers in afflicted populations.
Patients presenting with AAA; These patients will undergo a non-contrast enhanced magnetic resonance angiogram (MRA) (Imaging - MRA) to test for intracranial aneurysm(s). RNA, DNA testing will be planned on banked samples	Genetic: DNA, RNA testing; To test for the co-prevalence of shared genetic markers in afflicted populations.; Other: Imaging-MRA; Non-contrast Enhanced Magnetic Resonance Angiogram

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Revised cost-effective analysis measured in dollars/quality adjusted life years (QALY)	Revision of cost effective analysis for screening for AAA in those presenting with IA and for screening for IA in those with AAA.	2 years

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Analysis of Covariates for co-prevalence of aneurysms measured as present or absent	Analysis of covariates associated with co-prevalence of aneurysms in both territories.	Year 2
Biorepository (samples stored in freezer)	Develop a biorepository of DNA and RNA for individuals presenting with either IA or AAA, allowing specific future testing of shared genetic risk factors.	Year 2

Collaborators and Investigators

• Sponsor: University of Virginia
• Investigators: Principal Investigator: Bradford B Worrall, MD, MSc, University Of Virginia

Study record dates

Study Major Dates

• Study Start: April 1, 2014
• Primary Completion (Anticipated): April 1, 2017

Study Registration Dates

• First Submitted: December 1, 2014
• First Submitted That Met QC Criteria: August 15, 2016
• First Posted (Estimate): August 17, 2016

Study Record Updates

• Last Update Posted (Estimate): August 17, 2016
• Last Update Submitted That Met QC Criteria: August 15, 2016
• Last Verified: August 1, 2016

More Information

Terms related to this study

• Keywords: Aneurysm; Intracranial Aneurysm; Abdominal Aortic Aneurysm
• Additional Relevant MeSH Terms: Cardiovascular Diseases; Vascular Diseases; Cerebrovascular Disorders; Brain Diseases; Central Nervous System Diseases; Nervous System Diseases; Intracranial Arterial Diseases; Aortic Diseases; Aneurysm; Aortic Aneurysm; Aortic Aneurysm, Abdominal; Intracranial Aneurysm
• Other Study ID Numbers: 17341

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO
• IPD Plan Description: Summary data will be shared and published.