UVA Brain and Aortic Aneurysm Study

University of Virginia360 enrolled

Overview

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.

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

360

Conditions

Intracranial Aneurysm Abdominal Aortic Aneurysm

Interventions

Imaging-UltrasoundOTHER

Abdominal Ultrasound

Imaging-MRAOTHER

Non-contrast Enhanced Magnetic Resonance Angiogram

DNA, RNA testingGENETIC

To test for the co-prevalence of shared genetic markers in afflicted populations.

Eligibility

Sex: ALLMin age: 18 Years

Medical Language ↔ Plain English

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.

Locations (1)

University of Virginia

Charlottesville, Virginia, United States

RECRUITING

Outcomes

Primary Outcomes

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.

Time frame: 2 years

Secondary Outcomes

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.

Time frame: 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.

Time frame: Year 2

Central Contacts

Claire L McKinley, C.C.R.P.

CONTACT

434-924-9271 cw9ne@hscmail.mcc.virginia.edu

Julia Krupa, M.S.

CONTACT

434-924-4023 jkk8d@virginia.edu

Data from ClinicalTrials.gov

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