UVA Brain and Aortic Aneurysm Study

Abdominal Aortic Aneurysm Clinical Trial

— BAAS  

Official title:

The University of Virginia Brain and Aortic Aneurysm Study

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT02869464
• Other study ID #: 17341
• Status: Recruiting
• Phase: N/A
• First received: December 1, 2014
• Last updated: August 15, 2016
• Start date: April 2014

Study information

• Verified date: August 2016
• Source: University of Virginia
• Contact: Claire L McKinley, C.C.R.P.
• Phone: 434-924-9271
• Email: cw9ne[@]hscmail.mcc.virginia.edu
• Is FDA regulated: No
• Health authority: United States: Institutional Review Board
• Study type: Observational [Patient Registry]

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 360
• Est. primary completion date: April 2017
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 18 Years and older

Eligibility

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 Design

Observational Model: Cohort, Time Perspective: Prospective

Related Conditions & MeSH terms

• Abdominal Aortic Aneurysm
• Aneurysm
• Aortic Aneurysm
• Aortic Aneurysm, Abdominal
• Intracranial Aneurysm

Intervention

Other:
• Imaging-Ultrasound
Abdominal Ultrasound
• Imaging-MRA
Non-contrast Enhanced Magnetic Resonance Angiogram

Genetic:
• DNA, RNA testing
To test for the co-prevalence of shared genetic markers in afflicted populations.

Locations

Country	Name	City	State
United States	University of Virginia	Charlottesville	Virginia

Sponsors (1)

Lead Sponsor	Collaborator
University of Virginia

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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	No
Secondary	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	No
Secondary	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	No