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UVA Brain and Aortic Aneurysm Study (BAAS)

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ClinicalTrials.gov Identifier: NCT02869464
Recruitment Status : Unknown
Verified August 2016 by Bradford Worrall, MD, University of Virginia.
Recruitment status was:  Recruiting
First Posted : August 17, 2016
Last Update Posted : August 17, 2016
Sponsor:
Information provided by (Responsible Party):
Bradford Worrall, MD, University of Virginia

Tracking Information
First Submitted Date December 1, 2014
First Posted Date August 17, 2016
Last Update Posted Date August 17, 2016
Study Start Date April 2014
Estimated Primary Completion Date April 2017   (Final data collection date for primary outcome measure)
Current Primary Outcome Measures
 (submitted: August 15, 2016)
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.
Original Primary Outcome Measures Same as current
Change History No Changes Posted
Current Secondary Outcome Measures
 (submitted: August 15, 2016)
  • Analysis of Covariates for co-prevalence of aneurysms measured as present or absent [ Time Frame: Year 2 ]
    Analysis of covariates associated with co-prevalence of aneurysms in both territories.
  • Biorepository (samples stored in freezer) [ Time Frame: Year 2 ]
    Develop a biorepository of DNA and RNA for individuals presenting with either IA or AAA, allowing specific future testing of shared genetic risk factors.
Original Secondary Outcome Measures Same as current
Current Other Pre-specified Outcome Measures Not Provided
Original Other Pre-specified Outcome Measures Not Provided
 
Descriptive Information
Brief Title UVA Brain and Aortic Aneurysm Study
Official Title The University of Virginia Brain and Aortic Aneurysm Study
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.
Study Type Observational [Patient Registry]
Study Design Observational Model: Cohort
Time Perspective: Prospective
Target Follow-Up Duration 30 Days
Biospecimen Retention:   Samples With DNA
Description:
Approximately 3 mL of blood are obtained via venipuncture at the time of subject consent for banking and future research.
Sampling Method Non-Probability Sample
Study Population Patients who have been diagnosed with either a IA or AAA.
Condition
  • Intracranial Aneurysm
  • Abdominal Aortic Aneurysm
Intervention
  • Other: Imaging-Ultrasound
    Abdominal Ultrasound
  • Other: 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.
Study Groups/Cohorts
  • 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
    Interventions:
    • 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
    Interventions:
    • Other: Imaging-MRA
    • Genetic: DNA, RNA testing
Publications * Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruitment Information
Recruitment Status Unknown status
Estimated Enrollment
 (submitted: August 15, 2016)
360
Original Estimated Enrollment Same as current
Study Completion Date Not Provided
Estimated Primary Completion Date April 2017   (Final data collection date for primary outcome measure)
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.

Sex/Gender
Sexes Eligible for Study: All
Ages 18 Years and older   (Adult, Older Adult)
Accepts Healthy Volunteers No
Contacts Contact information is only displayed when the study is recruiting subjects
Listed Location Countries United States
Removed Location Countries  
 
Administrative Information
NCT Number NCT02869464
Other Study ID Numbers 17341
Has Data Monitoring Committee No
U.S. FDA-regulated Product Not Provided
IPD Sharing Statement
Plan to Share IPD: No
Plan Description: Summary data will be shared and published.
Responsible Party Bradford Worrall, MD, University of Virginia
Study Sponsor University of Virginia
Collaborators Not Provided
Investigators
Principal Investigator: Bradford B Worrall, MD, MSc University of Virginia
PRS Account University of Virginia
Verification Date August 2016