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Brain and Abdominal Aneurysm Study (BAAS)

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ClinicalTrials.gov Identifier: NCT01420991
Recruitment Status : Active, not recruiting
First Posted : August 22, 2011
Last Update Posted : October 20, 2017
Information provided by (Responsible Party):
James F. Meschia, Mayo Clinic

Brief Summary:

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.

Condition or disease

Study Type : Observational
Estimated Enrollment : 81 participants
Observational Model: Case-Only
Time Perspective: Prospective
Official Title: Brain and Abdominal Aneurysm Study (BAAS)
Study Start Date : August 2011
Primary Completion Date : February 2014
Estimated Study Completion Date : December 2024

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Aneurysms
U.S. FDA Resources

Primary Outcome Measures :
  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 Outcome Measures :
  1. Assessment of functional outcomes at 30 days [ Time Frame: 30days ]
    Functional outcomes will be assessed via telephone at one month post hospital discharge

Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years and older   (Adult, Senior)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Sampling Method:   Non-Probability Sample
Study Population
We will enroll 81 patients who present to MCH with aSAH.
  1. Men and women age ≥ 18 years.
  2. Diagnosis of intracranial aneurysm secured by magnetic resonance angiography (MRA), computed tomographic angiography (CTA), or catheter-based cerebral angiography.
  3. Diagnosis of subarachnoid hemorrhage diagnosed by head CT, brain MRI or lumbar puncture.
  4. Provides written informed consent.
  5. No know diagnosis of aortic aneurysm
  6. No history of prior screening for aortic aneurysm
  7. No condition like recent abdominal surgical scar that would preclude abdominal ultrasonography
  8. No therapy like abdominal hypothermia pads that would preclude abdominal ultrasonography

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT01420991

United States, Florida
Mayo Clinic in Florida
Jacksonville, Florida, United States, 32224
Sponsors and Collaborators
Mayo Clinic
Principal Investigator: James Meschia, MD Mayo Clinic

Responsible Party: James F. Meschia, MD, Mayo Clinic
ClinicalTrials.gov Identifier: NCT01420991     History of Changes
Other Study ID Numbers: 11-003509
First Posted: August 22, 2011    Key Record Dates
Last Update Posted: October 20, 2017
Last Verified: September 2017

Additional relevant MeSH terms:
Aortic Aneurysm, Abdominal
Vascular Diseases
Cardiovascular Diseases
Aortic Aneurysm
Aortic Diseases