Clinical Trials Directory

Trials / Unknown

UnknownNCT02869464

UVA Brain and Aortic Aneurysm Study

The University of Virginia Brain and Aortic Aneurysm Study

Status
Unknown
Phase
Study type
Observational
Enrollment
360 (estimated)
Sponsor
University of Virginia · Academic / Other
Sex
All
Age
18 Years
Healthy volunteers
Not accepted

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.

Conditions

Interventions

TypeNameDescription
OTHERImaging-UltrasoundAbdominal Ultrasound
OTHERImaging-MRANon-contrast Enhanced Magnetic Resonance Angiogram
GENETICDNA, RNA testingTo test for the co-prevalence of shared genetic markers in afflicted populations.

Timeline

Start date
2014-04-01
Primary completion
2017-04-01
First posted
2016-08-17
Last updated
2016-08-17

Locations

1 site across 1 country: United States

Source: ClinicalTrials.gov record NCT02869464. Inclusion in this directory is not an endorsement.