UVA Brain and Aortic Aneurysm Study

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

Get a concise snapshot of the trial, including recruitment status, study phase, enrollment targets, and key timeline milestones.

Recruitment Status

UNKNOWN

Total Enrollment

360 participants

Study Classification

OBSERVATIONAL

Study Start Date

2014-04-30

Brief Summary

Review the sponsor-provided synopsis that highlights what the study is about and why it is being conducted.

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.

Related Clinical Trials

Explore similar clinical trials based on study characteristics and research focus.

Occurrence of Abdominal Aortic Aneurysms in Patients With Aneurysmal Subarachnoid Hemorrhage

NCT07312565

Aneurysm Abdominal Cerebral Aneurysm Ruptured

NOT_YET_RECRUITING

Predicting Rupture of AAA by Anatomic and Hemodynamic Markers

NCT02463760

Aortic Aneurysm, Abdominal

COMPLETED

Brain and Abdominal Aneurysm Study

NCT01420991

Aneurysm

COMPLETED

Tonometry and Duplex Ultrasound to Predict AAA Progression and CV Events in Aneurysm Patients (1-2-3 Trial)

NCT03989011

Abdominal Aortic Aneurysm Cardiovascular Events

COMPLETED

A Prospective Analysis on the Expansion Rates of Abdominal Aortic Aneurysms

NCT02604303

Abdominal Aortic Aneurysm

UNKNOWN

Detailed Description

Dive into the extended narrative that explains the scientific background, objectives, and procedures in greater depth.

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

See the medical conditions and disease areas that this research is targeting or investigating.

Intracranial Aneurysm Abdominal Aortic Aneurysm

Study Design

Understand how the trial is structured, including allocation methods, masking strategies, primary purpose, and other design elements.

Observational Model Type

COHORT

Study Time Perspective

PROSPECTIVE

Study Groups

Review each arm or cohort in the study, along with the interventions and objectives associated with them.

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

Imaging-Ultrasound

Intervention Type OTHER

Abdominal Ultrasound

DNA, RNA testing

Intervention Type GENETIC

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

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

Imaging-MRA

Intervention Type OTHER

Non-contrast Enhanced Magnetic Resonance Angiogram

DNA, RNA testing

Intervention Type GENETIC

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

Interventions

Learn about the drugs, procedures, or behavioral strategies being tested and how they are applied within this trial.

Imaging-Ultrasound

Abdominal Ultrasound

Intervention Type OTHER

Imaging-MRA

Non-contrast Enhanced Magnetic Resonance Angiogram

Intervention Type OTHER

DNA, RNA testing

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

Intervention Type GENETIC

Eligibility Criteria

Check the participation requirements, including inclusion and exclusion rules, age limits, and whether healthy volunteers are 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.

Minimum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No