Intracranial AneurysmBAASNCT02869464
UVA Brain and Aortic Aneurysm Study
An observational study of Intracranial Aneurysm and Abdominal Aortic Aneurysm, run by University of Virginia at 1 site in United States.
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. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Intracranial Aneurysm, Abdominal Aortic Aneurysm
- What is being tested?
- Imaging-Ultrasound, Imaging-MRA and DNA, RNA testing
- How many people
- 360 participants
- Where
- 1 siteUnited States
- Study dates
- Apr 2014to Apr 2017
- How long will I take part?
- 30 Days
- Phase
- Observational
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Study population: Patients who have been diagnosed with either a IA or AAA.
Who may be able to join
- 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)
Who cannot join
- 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.
Trial locations and contacts
1 site in 1 country.
United States1 site, 1 recruiting
- Recruiting
University of Virginia
Charlottesville, Virginia, 22903
Claire L McKinley, C.C.R.P., 434-924-9271, cw9ne@virginia.edu
Julia K Krupa, M.S., 434-924-4023, jkk8d@virginia.edu
About this study
Official title: The University of Virginia Brain and Aortic Aneurysm Study
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.
Read the 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
- Intracranial Aneurysm, Abdominal Aortic Aneurysm
- Being tested
- Imaging-Ultrasound, Imaging-MRA, DNA, RNA testing
- Keywords
- Aneurysm, Intracranial Aneurysm, Abdominal Aortic Aneurysm
- Medical subject headings
- Intracranial Aneurysm, Aortic Aneurysm, Abdominal, Aneurysm
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
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.
| Study group | Role | What they receive |
|---|---|---|
| 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 Receives: Other: Imaging-Ultrasound; Genetic: DNA, RNA testing | |
| 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 Receives: Other: Imaging-MRA; Genetic: DNA, RNA testing |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: 2 years
Secondary outcomes (2)
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.
Measured: 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.
Measured: Year 2
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted17 Aug 2016 (estimated)
- Study startApr 2014
- Primary completionApr 2017 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Intracranial AneurysmStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Cohort
- Time perspective
- Prospective
- Enrolment
- 360 participants (estimated)
- Target duration
- 30 Days
Sponsor and investigators
- Lead sponsor
- University of Virginia
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Bradford Worrall, MD, University of Virginia
- Investigators
- Bradford B Worrall, MD, MSc, Principal investigator, University of Virginia
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02869464
- Sponsor's protocol ID
- 17341
- Acronym
- BAAS
- Status last verified
- Aug 2016
- First submitted
- 1 Dec 2014
- Last updated
- 17 Aug 2016
- Results posted
- No
- Data monitoring committee
- No
- Individual data sharing
- No: Summary data will be shared and published.
Study at a glance
From the registry record, last updated by the sponsor on 17 Aug 2016. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- The University of Virginia Brain and Aortic Aneurysm Study
- ClinicalTrials.gov ID
- NCT02869464
- Acronym / sponsor ID
- BAAS / 17341
- Conditions
- Intracranial Aneurysm, Abdominal Aortic Aneurysm
- Keywords
- Aneurysm, Intracranial Aneurysm, Abdominal Aortic Aneurysm
- Study type
- Observational
- Recruitment status
- Unknown status
- Enrolment
- 360 participants (estimated)
- Lead sponsor
- University of VirginiaUniversity, hospital or other
- Study start
- Apr 2014
- Primary completion
- Apr 2017 (estimated)
- First posted
- 17 Aug 2016 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
- Target follow-up
- 30 Days
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Patients presenting with IA | – | Other: Imaging-Ultrasound, Genetic: DNA, RNA testingThese 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 | – | Other: Imaging-MRA, Genetic: DNA, RNA testingThese 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 |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- Patients who have been diagnosed with either a IA or AAA.
Key inclusion criteria (3 listed)
- 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)
Key exclusion criteria (8 listed)
- 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.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Imaging-UltrasoundAbdominal Ultrasound | Other | Patients presenting with IA |
| Imaging-MRANon-contrast Enhanced Magnetic Resonance Angiogram | Other | Patients presenting with AAA |
| DNA, RNA testingTo test for the co-prevalence of shared genetic markers in afflicted populations. | Genetic | Patients presenting with AAA, Patients presenting with IA |
Primary outcome
Revised cost-effective analysis measured in dollars/quality adjusted life years (QALY)
Time frame: 2 years
Revision of cost effective analysis for screening for AAA in those presenting with IA and for screening for IA in those with AAA.
2 secondary outcomes
Analysis of Covariates for co-prevalence of aneurysms measured as present or absent
Time frame: Year 2
Biorepository (samples stored in freezer)
Time frame: Year 2
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 17 Aug 2016.
- Individual participant dataSharing planned: No. Summary data will be shared and published.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Bradford B Worrall, MD, MSc principal investigator
University of Virginia
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Intracranial Aneurysm and Abdominal Aortic Aneurysm, run by University of Virginia at 1 site in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 3 inclusion and 8 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: status not confirmed, as of the sponsor's last update on 17 Aug 2016. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Claire L McKinley, C.C.R.P. (434-924-9271, cw9ne@hscmail.mcc.virginia.edu), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Revised cost-effective analysis measured in dollars/quality adjusted life years (QALY) (time frame: 2 years). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 17 Aug 2016.