AneurysmBAASNCT01420991
Brain and Abdominal Aneurysm Study
An observational study of Aneurysm, run by Mayo Clinic at 2 sites in United States.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Aneurysm
- How many people
- 271 participants
- Where
- 2 sitesUnited States
- Study dates
- 11 Oct 2021to 2 Mar 2024
- Phase
- Observational
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Study population: We will enroll 81 patients who present to MCH with aSAH.
- 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
Trial locations and contacts
2 sites in 1 country.
United States2 sites
Mayo Clinic in Florida
Jacksonville, Florida, 32224
Mayo Clinic in Rochester
Rochester, Minnesota, 55905
About this study
Official title: Brain and Abdominal Aneurysm Study (BAAS)
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.
- Conditions
- Aneurysm
- Medical subject headings
- Aneurysm
What is being measured
The primary outcome is the main question the study is designed to answer.
Prevalence
The primary aim is to determine the proportion of patients who are found to have an AAA at the time of enrollment.
Measured: day 1
Secondary outcomes (1)
Assessment of functional outcomes at 30 days
Functional outcomes will be assessed via telephone at one month post hospital discharge
Measured: 30days
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted22 Aug 2011 (estimated)
- Study start11 Oct 2021
- Primary completion2 Mar 2024
- Study completion2 Mar 2024
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for AneurysmStudies of the same condition, open and under way.
- More trials run by Mayo ClinicThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Case only
- Time perspective
- Prospective
- Enrolment
- 271 participants (actual)
Sponsor and investigators
- Lead sponsor
- Mayo Clinic
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, James F. Meschia, Mayo Clinic
- Investigators
- James Meschia, MD, Principal investigator, Mayo Clinic
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01420991
- Sponsor's protocol ID
- 11-003509
- Acronym
- BAAS
- Status last verified
- Mar 2025
- First submitted
- 15 Aug 2011
- Last updated
- 16 Apr 2025
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 16 Apr 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Brain and Abdominal Aneurysm Study (BAAS)
- ClinicalTrials.gov ID
- NCT01420991
- Acronym / sponsor ID
- BAAS / 11-003509
- Conditions
- Aneurysm
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 271 participants (actual)
- Lead sponsor
- Mayo ClinicUniversity, hospital or other
- Study start
- 11 Oct 2021 (actual)
- Primary completion
- 2 Mar 2024 (actual)
- Study completion
- 2 Mar 2024 (actual)
- First posted
- 22 Aug 2011 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Observational model
- Case only
- Time perspective
- Prospective
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- We will enroll 81 patients who present to MCH with aSAH.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Primary outcome
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.
1 secondary outcome
Assessment of functional outcomes at 30 days
Time frame: 30days
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 16 Apr 2025.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
James Meschia, MD principal investigator
Mayo Clinic
2 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Aneurysm, run by Mayo Clinic at 2 sites in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 16 Apr 2025. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 2 sites in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Prevalence (time frame: day 1). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 16 Apr 2025.