Viewing Study NCT00071565



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Study NCT ID: NCT00071565
Status: COMPLETED
Last Update Posted: 2015-08-18
First Post: 2003-10-28

Brief Title: Familial Intracranial Aneurysm Study II
Sponsor: University of Cincinnati
Organization: University of Cincinnati

Study Overview

Official Title: Familial Intracranial Aneurysm Study II
Status: COMPLETED
Status Verified Date: 2015-08
Last Known Status: None
Delayed Posting: No
If Stopped, Why?: Not Stopped
Has Expanded Access: False
If Expanded Access, NCT#: N/A
Has Expanded Access, NCT# Status: N/A
Acronym: None
Brief Summary: 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
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 genesA 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 brotherssisters 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 andor intracranial aneurysm ruptures in people who are at risk for this condition

Study Oversight

Has Oversight DMC: None
Is a FDA Regulated Drug?: None
Is a FDA Regulated Device?: None
Is an Unapproved Device?: None
Is a PPSD?: None
Is a US Export?: None
Is an FDA AA801 Violation?: None
Secondary IDs
Secondary ID Type Domain Link
R01NS039512-06A1 NIH None httpsreporternihgovquickSearchR01NS039512-06A1