Familial Intracranial Aneurysm Study II

The recruitment status of this study is unknown because the information has not been verified recently.
Verified December 2011 by University of Cincinnati.
Recruitment status was  Active, not recruiting
Sponsor:
Collaborator:
Information provided by (Responsible Party):
Joseph Broderick, University of Cincinnati
ClinicalTrials.gov Identifier:
NCT00071565
First received: October 28, 2003
Last updated: December 16, 2011
Last verified: December 2011
  Purpose

The purposes of this study are to identify possible genes that may increase the risk of aneurysm development in the brain, and to determine the effect of environmental factors such as cigarette smoking and high blood pressure on the expression of these genes.


Condition
Intracranial Aneurysm
Subarachnoid Hemorrhage

Study Type: Observational
Study Design: Observational Model: Family-Based
Time Perspective: Prospective
Official Title: Familial Intracranial Aneurysm Study II

Resource links provided by NLM:


Further study details as provided by University of Cincinnati:

Biospecimen Retention:   Samples With DNA

blood sample


Estimated Enrollment: 5875
Study Start Date: September 2002
Estimated Study Completion Date: August 2012
Estimated Primary Completion Date: August 2012 (Final data collection date for primary outcome measure)
Groups/Cohorts
1
475 families with multiple affected family members (phase I) 200 families with multiple affected family members (phase II) 1800 subjects with sporadic intracranial aneurysms

Detailed Description:

Intracranial aneurysms are "blisters" which form within the arteries at the base of the brain. A rupture of an aneurysm may lead to subarachnoid hemorrhage (SAH). The mortality rates of patients suffering from a SAH is 40 to 44 percent , with many survivors enduring major disability. Most of the deaths from SAH are due to rapid and massive brain injury from the initial bleeding, which is not correctable by medical and surgical intervention. Thus, prevention of aneurysm formation is of paramount importance.

Scientific evidence suggests that a genetic component plays an important role in the development of intracranial aneurysms, however the specific genes have not been identified. The Familial Intracranial Aneurysm Study is a collaborative research effort of neurologists and neurosurgeons throughout the United States, Canada, Australia and New Zealand to identify possible genes that may increase the risk of stroke, and particularly, the development of aneurysms in the blood vessels of the brain. This study will involve 475 families with multiple affected family members, and will also determine the effect of environmental factors such as cigarette smoking and high blood pressure on the expression of the genes.A group of physicians from throughout North America, Australia and New Zealand have formed a collaborative effect to identify genes that may be important in the development of aneurysms in the blood vessels of the brain. This study of affected individuals and families, known as the Familial Intracranial Aneurysm (FIA) study, is sponsored by the National Institutes of Health and has involved over 475 families.

FIA II will involve an additional 200 families plus 1800 subjects with an Intracranial Aneurysm but no family history. These families and individuals will be used to replicate the findings of FIA I. FIA II will take place in North America only.

To be eligible to participate in this study, families must have two or more affected pairs of siblings (brothers/sisters) or 3 or more family members affected with intracranial aneurysms. Subjects can participate if they do not have an eligible family history, but do have a confirmed intracranial aneurysm.

Participants will be asked to complete a family history questionnaire (if they have a family history) and a medical history questionnaire. They will also have their blood pressure measured and will give a small sample of blood. In addition, medical records will be requested to confirm the diagnosis of intracranial aneurysms. There will be no monetary compensation for participation.

The identification of susceptibility genes, along with a better understanding of environmental interactions such as cigarette smoking, may result in preventing the development of intracranial aneurysms and/or intracranial aneurysm ruptures in people who are at risk for this condition.

  Eligibility

Ages Eligible for Study:   13 Years and older
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   Yes
Sampling Method:   Non-Probability Sample
Study Population

475 families with multiple affected family members will be selected in this collaborative research effort of neurologists and neurosurgeons throughout the United States, Canada, Australia and New Zealand (completed during phase I) 200 Families with multiple affected family members located in North America, and an additional 1800 subjects with sporadic aneurysm without a qualifing family history.

Criteria

Inclusion:

  • To be eligible to participate in this study, families must have two or more affected pairs of siblings (brothers/sisters) or 3 or more family members affected with intracerebral aneurysms.

Sporadic aneurysm subjects must have a confirmed aneurysm.

Exclusion:

  • A history of polycystic kidney disease, Marfan's Syndrome, Ehlers Danlos Syndrome, or fibromuscular dysplasia.
  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: NCT00071565

Locations
United States, Alabama
University of Alabama
Birmingham, Alabama, United States, 35294
United States, California
University of California,
San Francisco, California, United States, 94143-0114
United States, Florida
University of Florida
Gainesville, Florida, United States, 32610-0265
United States, Indiana
Indianapolis Neurosurgical Group
Indianapolis, Indiana, United States, 46202
United States, Maryland
University of Maryland
Baltimore, Maryland, United States, 21201-1595
Johns Hopkins University School of Medicine
Baltimore, Maryland, United States, 21287
United States, Massachusetts
Massachusetts General Hospital
Boston, Massachusetts, United States, 02114-2698
Brigham & Women's Hospital
Boston, Massachusetts, United States, 02115
United States, Michigan
University of Michigan
Ann Arbor, Michigan, United States, 48109-0489
United States, Minnesota
Mayo Clinic
Rochester, Minnesota, United States, 55905
United States, Missouri
Washington University
St. Louis, Missouri, United States, 63110
United States, New York
Columbia University,
New York, New York, United States, 10032
United States, Ohio
University of Cincinnati, Department of Neurology
Cincinnati, Ohio, United States, 45267
United States, Pennsylvania
Allegheny General Hospital
Pittsburgh, Pennsylvania, United States, 15212
United States, Virginia
University of Virginia
Charlottesville, Virginia, United States, 22903
United States, Washington
University of Washington
Seattle, Washington, United States, 98104
Sponsors and Collaborators
University of Cincinnati
Investigators
Principal Investigator: Joseph P. Broderick, M.D. University of Cincinnati
  More Information

Additional Information:
No publications provided by University of Cincinnati

Additional publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):
Responsible Party: Joseph Broderick, Joseph P. Broderick, University of Cincinnati
ClinicalTrials.gov Identifier: NCT00071565     History of Changes
Other Study ID Numbers: R01NS39512, R01NS039512-06A1
Study First Received: October 28, 2003
Last Updated: December 16, 2011
Health Authority: United States: Federal Government

Keywords provided by University of Cincinnati:
familial intracranial aneurysm
intracranial aneurysm
brain aneurysm
aneurysm
subarachnoid hemorrhage
stroke

Additional relevant MeSH terms:
Aneurysm
Intracranial Aneurysm
Hemorrhage
Subarachnoid Hemorrhage
Vascular Diseases
Cardiovascular Diseases
Intracranial Arterial Diseases
Cerebrovascular Disorders
Brain Diseases
Central Nervous System Diseases
Nervous System Diseases
Pathologic Processes
Intracranial Hemorrhages

ClinicalTrials.gov processed this record on July 26, 2014