Recruiting

Observational Study

Sponsor:

University of Virginia

Code:

NCT02869464

Conditions

Intracranial Aneurysm

Abdominal Aortic Aneurysm

Eligibility Criteria

Sex: All

Age: 18+

Healthy Volunteers: Not accepted

Interventions

Imaging-Ultrasound

Imaging-MRA

DNA, RNA testing

Study Details

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.

Conditions

Intracranial Aneurysm

Abdominal Aortic Aneurysm

Study ID

NCT02869464

Start date

Apr, 2014

Status verified date

Aug, 2016

Primary completion date

Apr, 2017

Anticipated

Eligibility Criteria

Eligibility Criteria

Sex: All

Age: 18+

Healthy Volunteers: Not accepted

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

Enrollment

360 participants

Anticipated

Interventions and Outcome Measures

Arms

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

Interventions

Imaging-Ultrasound

Abdominal Ultrasound

Imaging-MRA

Non-contrast Enhanced Magnetic Resonance Angiogram

DNA, RNA testing

To test for the co-prevalence of shared genetic markers in afflicted populations.

Primary outcome measure

  • Revised cost-effective analysis measured in dollars/quality adjusted life years (QALY) [ Time Frame: 2 years ]

Central Contacts and Locations

Central contacts

Claire L McKinley, C.C.R.P.

434-924-9271cw9ne@hscmail.mcc.virginia.edu

Julia Krupa, M.S.

434-924-4023jkk8d@virginia.edu

Locations

University of Virginia

Recruiting

Charlottesville, Virginia, United States, 22903

Contacts

Claire L McKinley, C.C.R.P.

434-924-9271cw9ne@virginia.edu

Julia K Krupa, M.S.

434-924-4023jkk8d@virginia.edu

Principal Investigator:

Bradford B Worrall, M.D.

More Information

Sponsor

University of Virginia

Last update posted

Aug 17, 2016

Last verified

Aug, 2016

Keywords

  • Aneurysm
  • Intracranial Aneurysm
  • Abdominal Aortic Aneurysm

Trial information was received from ClinicalTrials.gov and was last updated on 2026-09-10. This information was provided to ClinicalTrials.gov by University of Virginia on 2016-08-17.