Clinical trial NCT01420991: Brain and Abdominal Aneurysm Study
Official title: Brain and Abdominal Aneurysm Study (BAAS)
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Aneurysm
Lead sponsor: Mayo Clinic
Sponsor class: OTHER
First posted: 2011-08-22
Enrollment: 271
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: CASE_ONLY
Time perspective: PROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: We will enroll 81 patients who present to MCH with aSAH.

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.


Eligibility criteria: 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

Primary outcomes:
measure: Prevalence
timeFrame: day 1
Secondary outcomes:
measure: Assessment of functional outcomes at 30 days
timeFrame: 30days
Other outcomes:
Locations:
city: Jacksonville
country: United States
facility: Mayo Clinic in Florida
state: Florida
city: Rochester
country: United States
facility: Mayo Clinic in Rochester
state: Minnesota
Study officials:
affiliation: Mayo Clinic
name: James Meschia, MD
role: PRINCIPAL_INVESTIGATOR
References: