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Brain and Abdominal Aneurysm Study (BAAS)

This study is ongoing, but not recruiting participants.
Sponsor:
Information provided by (Responsible Party):
James F. Meschia, Mayo Clinic
ClinicalTrials.gov Identifier:
NCT01420991
First received: August 15, 2011
Last updated: May 28, 2014
Last verified: May 2014
  Purpose

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
Aneurysm

Study Type: Observational
Study Design: Observational Model: Case-Only
Time Perspective: Prospective
Official Title: Brain and Abdominal Aneurysm Study (BAAS)

Resource links provided by NLM:


Further study details as provided by Mayo Clinic:

Primary Outcome Measures:
  • Prevalence [ Time Frame: day 1 ] [ Designated as safety issue: No ]
    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:
  • Assessment of functional outcomes at 30 days [ Time Frame: 30days ] [ Designated as safety issue: No ]
    Functional outcomes will be assessed via telephone at one month post hospital discharge


Estimated Enrollment: 81
Study Start Date: August 2011
Estimated Study Completion Date: December 2014
Primary Completion Date: February 2014 (Final data collection date for primary outcome measure)
  Eligibility

Ages Eligible for Study:   18 Years and older
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Sampling Method:   Non-Probability Sample
Study Population

We will enroll 81 patients who present to MCH with aSAH.

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
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT01420991

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

No publications provided

Responsible Party: James F. Meschia, MD, Mayo Clinic
ClinicalTrials.gov Identifier: NCT01420991     History of Changes
Other Study ID Numbers: 11-003509
Study First Received: August 15, 2011
Last Updated: May 28, 2014
Health Authority: United States: Institutional Review Board

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

ClinicalTrials.gov processed this record on November 20, 2014