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Completed

NCT Number: NCT01420991

Brain and Abdominal Aneurysm Study

Aneurysmal subarachnoid hemorrhage (aSAH) is the most deadly kind of stroke. Each year, 40,000 Americans have SAH. Case-fatality approaches 60% and more than half of those who die do so before reaching the hospital. Most commonly, SAH results from rupture of an intracranial aneurysm. Screening high-risk individuals could identify those at greatest risk and decrease the devastating effect of SAH. Aortic Aneurysm also constitutes a major public health problem with high lethality. Current estimates are that ruptured aortic aneurysm kills 13,000 Americans each year. Screening efforts have effectively lowered mortality from aortic aneurysm rupture but a high proportion of those who die did not have a diagnosis of aortic aneurysm prior to rupture.

The relationship between intracranial and aortic aneurysm has long been recognized, but poorly quantified. Recent genome-wide association studies (GWAS) provide a molecular biological evidence for a shared pathophysiology. The chromosome 9p21 locus confers increased risk for both intracranial aneurysms and aortic aneurysms. These GWAS data, along with linkage data for other susceptibility loci, indicate that individuals and families harboring one type of aneurysm may be at especially increased risk of the other.

The rationale for this project is that opportunistic screening for abdominal aortic aneurysms (AAA) may be warranted in patients who present with aneurysmal subarachnoid hemorrhage. This study is meant to see if the yield of screening in this population is too low to justify its routine use. The investigators plan to systematically screen for AAA in all cases of aSAH presenting to MCH for treatment. If no individual out of 81 consecutively screened cases of aSAH has evidence of AAA, then the investigators can have strong confidence that there is a less than 5% chance of finding an AAA in the patient population.

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Key information

Age range

18 year and older

Sex eligibility

All sexes

Study type

Observational

Primary location

Mayo Clinic in Florida, Jacksonville, Florida, United States

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Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

  • Men and women age ≥ 18 years.
  • Diagnosis of intracranial aneurysm secured by magnetic resonance angiography (MRA), computed tomographic angiography (CTA), or catheter-based cerebral angiography.
  • Diagnosis of subarachnoid hemorrhage diagnosed by head CT, brain MRI or lumbar puncture.
  • Provides written informed consent.
  • No know diagnosis of aortic aneurysm
  • No history of prior screening for aortic aneurysm
  • No condition like recent abdominal surgical scar that would preclude abdominal ultrasonography
  • No therapy like abdominal hypothermia pads that would preclude abdominal ultrasonography

Treatment and study plan

Primary outcomes

  1. Prevalence

    Time frame: day 1

    The primary aim is to determine the proportion of patients who are found to have an AAA at the time of enrollment.

Secondary outcomes

  1. Assessment of functional outcomes at 30 days

    Time frame: 30days

    Functional outcomes will be assessed via telephone at one month post hospital discharge

Sponsors and collaborators

Lead sponsor

Mayo Clinic

Other

Registry information

Official study title

Brain and Abdominal Aneurysm Study (BAAS)

Acronym: BAAS

Important dates

Study start
2021
Primary completion
2024
Study completion
2024
First posted
Aug 22, 2011
Registry last updated
Apr 16, 2025

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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