UVA Brain and Aortic Aneurysm Study

NCT02869464 | Unknown

• 1 other identifier: 17341
• Study Type: observational
• Target: 360
• Locations: 1 country
• Sites: 1

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

Keywords

Aneurysm; Intracranial Aneurysm; Abdominal Aortic Aneurysm

Outcome Measures

Primary Outcomes (1)

• 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

Secondary Outcomes (2)

• Analysis of Covariates for co-prevalence of aneurysms measured as present or absent

  Year 2

• Biorepository (samples stored in freezer)

  Year 2

Study Arms (2)

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

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

Other: Imaging-MRA; Genetic: DNA, RNA testing

Interventions

Imaging-Ultrasound OTHER

Abdominal Ultrasound

Patients presenting with IA

Imaging-MRA OTHER

Non-contrast Enhanced Magnetic Resonance Angiogram

Patients presenting with AAA

DNA, RNA testing GENETIC

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

Patients presenting with AAA; Patients presenting with IA

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)
• Sampling Method: Non-Probability Sample

Study Population

Patients who have been diagnosed with either a IA or AAA.

You may qualify if:

• 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)

You may not qualify if:

• 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.

Sponsors & Collaborators

• University of Virginia: lead

Study Sites (1)

University of Virginia

Charlottesville, Virginia, 22903, United States

RECRUITING

Biospecimen

Retention: SAMPLES WITH DNA

Approximately 3 mL of blood are obtained via venipuncture at the time of subject consent for banking and future research.

MeSH Terms

Conditions

Intracranial Aneurysm; Aortic Aneurysm, Abdominal; Aneurysm

Interventions

High-Energy Shock Waves; DNA

Condition Hierarchy (Ancestors)

Intracranial Arterial Diseases; Cerebrovascular Disorders; Brain Diseases; Central Nervous System Diseases; Nervous System Diseases; Vascular Diseases; Cardiovascular Diseases; Aortic Aneurysm; Aortic Diseases

Intervention Hierarchy (Ancestors)

Ultrasonic Waves; Sound; Radiation, Nonionizing; Radiation; Physical Phenomena; Nucleic Acids; Nucleic Acids, Nucleotides, and Nucleosides

Study Officials

• Bradford B Worrall, MD, MSc

  University of Virginia

  PRINCIPAL INVESTIGATOR

Central Study Contacts

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

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: PROSPECTIVE
• Target Duration: 30 Days
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Bradford B. Worrall, M.D.

Study Record Dates

• First Submitted: December 1, 2014
• First Posted: August 17, 2016
• Study Start: April 1, 2014
• Primary Completion: April 1, 2017
• Last Updated: August 17, 2016

Record last verified: 2016-08

Data Sharing

• IPD Sharing: Will not share

Locations

US (1)