Clinical trial NCT02869464: UVA Brain and Aortic Aneurysm Study
Official title: The University of Virginia Brain and Aortic Aneurysm Study
Study type: OBSERVATIONAL
Overall status: UNKNOWN
Conditions: Intracranial Aneurysm
Abdominal Aortic Aneurysm
Keywords: Aneurysm
Intracranial Aneurysm
Abdominal Aortic Aneurysm
Lead sponsor: University of Virginia
Sponsor class: OTHER
First posted: 2016-08-17
Enrollment: 360
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: COHORT
Time perspective: PROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: Patients who have been diagnosed with either a IA or AAA.

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.

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.

Primary outcomes:
measure: Revised cost-effective analysis measured in dollars/quality adjusted life years (QALY)
timeFrame: 2 years
Secondary outcomes:
measure: Analysis of Covariates for co-prevalence of aneurysms measured as present or absent
timeFrame: Year 2
measure: Biorepository (samples stored in freezer)
timeFrame: Year 2
Other outcomes:
Locations:
city: Charlottesville
country: United States
facility: University of Virginia
state: Virginia
Study officials:
affiliation: University of Virginia
name: Bradford B Worrall, MD, MSc
role: PRINCIPAL_INVESTIGATOR
References: