Brain and Abdominal Aneurysm Study

NCT ID: NCT01420991

Last Updated: 2025-04-16

Basic Information

• Recruitment Status: COMPLETED
• Total Enrollment: 271 participants
• Study Classification: OBSERVATIONAL
• Study Start Date: 2021-10-11
• Study Completion Date: 2024-03-02

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.

Conditions

Aneurysm

Study Design

• Observational Model Type: CASE_ONLY
• Study Time Perspective: PROSPECTIVE

Eligibility Criteria

Inclusion 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

• Minimum Eligible Age: 18 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Mayo Clinic

OTHER

Sponsor Role: lead

Responsible Party

James F. Meschia

MD

Responsibility Role: PRINCIPAL_INVESTIGATOR

Principal Investigators

James Meschia, MD

Role: PRINCIPAL_INVESTIGATOR

Mayo Clinic

Locations

Mayo Clinic in Florida

Jacksonville, Florida, United States

Mayo Clinic in Rochester

Rochester, Minnesota, United States

Countries

United States

Other Identifiers

11-003509

Identifier Type: -

Identifier Source: org_study_id