- ICH GCP
- 미국 임상 시험 레지스트리
- 임상시험 NCT00071565
Familial Intracranial Aneurysm Study II
연구 개요
상세 설명
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.
연구 유형
등록 (실제)
연락처 및 위치
연구 장소
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Alabama
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Birmingham, Alabama, 미국, 35294
- University of Alabama
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California
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San Francisco, California, 미국, 94143-0114
- University of California,
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Florida
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Gainesville, Florida, 미국, 32610-0265
- University of Florida
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Indiana
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Indianapolis, Indiana, 미국, 46202
- Indianapolis Neurosurgical Group
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Maryland
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Baltimore, Maryland, 미국, 21287
- Johns Hopkins University School Of Medicine
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Baltimore, Maryland, 미국, 21201-1595
- University of Maryland
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Massachusetts
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Boston, Massachusetts, 미국, 02115
- Brigham & Women's Hospital
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Boston, Massachusetts, 미국, 02114-2698
- Massachusetts General Hospital
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Michigan
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Ann Arbor, Michigan, 미국, 48109-0489
- University of Michigan
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Minnesota
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Rochester, Minnesota, 미국, 55905
- Mayo Clinic
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Missouri
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St. Louis, Missouri, 미국, 63110
- Washington University
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New York
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New York, New York, 미국, 10032
- Columbia University,
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Ohio
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Cincinnati, Ohio, 미국, 45267
- University of Cincinnati, Department of Neurology
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Pennsylvania
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Pittsburgh, Pennsylvania, 미국, 15212
- Allegheny General Hospital
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Virginia
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Charlottesville, Virginia, 미국, 22903
- University of Virginia
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Washington
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Seattle, Washington, 미국, 98104
- University of Washington
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참여기준
자격 기준
공부할 수 있는 나이
건강한 자원 봉사자를 받아들입니다
연구 대상 성별
샘플링 방법
연구 인구
설명
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.
공부 계획
연구는 어떻게 설계됩니까?
디자인 세부사항
코호트 및 개입
그룹/코호트 |
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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
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공동 작업자 및 조사자
수사관
- 수석 연구원: Joseph P. Broderick, M.D., University of Cincinnati
간행물 및 유용한 링크
연구 기록 날짜
연구 주요 날짜
연구 시작
기본 완료 (실제)
연구 완료 (실제)
연구 등록 날짜
최초 제출
QC 기준을 충족하는 최초 제출
처음 게시됨 (추정)
연구 기록 업데이트
마지막 업데이트 게시됨 (추정)
QC 기준을 충족하는 마지막 업데이트 제출
마지막으로 확인됨
추가 정보
이 정보는 변경 없이 clinicaltrials.gov 웹사이트에서 직접 가져온 것입니다. 귀하의 연구 세부 정보를 변경, 제거 또는 업데이트하도록 요청하는 경우 register@clinicaltrials.gov. 문의하십시오. 변경 사항이 clinicaltrials.gov에 구현되는 즉시 저희 웹사이트에도 자동으로 업데이트됩니다. .