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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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| 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 |
| |
| 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 |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Imaging-Ultrasound | Other | Abdominal Ultrasound |
| |
| 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 |
| 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) |
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Inclusion Criteria:
Exclusion Criteria:
Note: Pregnancy is not a reason to exclude, but imaging done for the study will be postponed until after the subject has given birth.
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Patients who have been diagnosed with either a IA or AAA.
| Name | Role | Phone | Extension | |
|---|---|---|---|---|
| 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 |
| Name | Affiliation | Role |
|---|---|---|
| Bradford B Worrall, MD, MSc | University of Virginia | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| University of Virginia | Recruiting | Charlottesville | Virginia | 22903 | United States |
Summary data will be shared and published.
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| ID | Term |
|---|---|
| D002532 | Intracranial Aneurysm |
| D017544 | Aortic Aneurysm, Abdominal |
| D000783 | Aneurysm |
| ID | Term |
|---|---|
| D020765 | Intracranial Arterial Diseases |
| D002561 | Cerebrovascular Disorders |
| D001927 | Brain Diseases |
| D002493 | Central Nervous System Diseases |
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| ID | Term |
|---|---|
| D019220 | High-Energy Shock Waves |
| D004247 | DNA |
| ID | Term |
|---|---|
| D000069453 | Ultrasonic Waves |
| D013016 | Sound |
| D011840 | Radiation, Nonionizing |
| D011827 | Radiation |
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Approximately 3 mL of blood are obtained via venipuncture at the time of subject consent for banking and future research.
| Imaging-MRA |
| Other |
Non-contrast Enhanced Magnetic Resonance Angiogram |
|
| DNA, RNA testing | Genetic | To test for the co-prevalence of shared genetic markers in afflicted populations. |
|
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 |
| D009422 | Nervous System Diseases |
| D014652 | Vascular Diseases |
| D002318 | Cardiovascular Diseases |
| D001014 | Aortic Aneurysm |
| D001018 | Aortic Diseases |
| D055585 |
| Physical Phenomena |
| D009696 | Nucleic Acids |
| D009706 | Nucleic Acids, Nucleotides, and Nucleosides |