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PubMed
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Stroke Interventions in Clinical Trials
Printable Version
FIA II
Familial Intracranial Aneurysm Study (phase II)



Principal Investigator
Joseph Broderick, M.D.

PI Address
University of Cincinnati
260 Stetson Street, Ste. 2300
Cincinnati, OH45267-0525

Contact Address
Laura Sauerbeck
University of Cincinnati
260 Stetson Street, Suite 2300
Cincinnati, OH 45267-0525
Phone: 513-558-1742
Toll Free 800-503-3427

Contact Email
laura.sauerbeck@uc.edu

Sponsor



Study Size Actual:3247
Study Size Planned:5875
Centers Actual:20
Centers Planned:25
Min Age:13
ISRCTN#NCT00071565
Status:
This study is ongoing, with active recruitment of participants.

Purpose:
To identify possible genes that may increase the risk of stroke and particularly the development of aneurysms in blood vessels of the brain.

Location(s):
United States, Canada

Year Started: 2009
Year Finished: 2011

Design:
Multicenter, retrospective and prospecting, genome-wide linkage study.

Inclusion Criteria
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.

Exclusion Criteria
History of polycystic kidney disease, Marfan’s Syndrome, Ehler Danlos Syndrome, Moya Moya or fibromusclar dysplasia.

Patient Involvement:
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.

Primary Outcome:
SNP Genotyping; nonparametic (allele sharing) linkage analysis, including environmental risk factors is conducted; and fine gene mapping will be preformed

Comments:
546 families have been enrolled—the genome screening has been run on 395 families as of December 2007. Investigators were granted a no cost extension through September 14, 2009 during which time 500 sporadic subjects were enrolled. Continuation of this study was awared September 14, 2009 which will 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.

Source of Information:
ClinicalTrials.gov

Web Links and Publications:
Familial Intracranial Aneurysm Study Website

Familial Intracranial Aneurysm (phase I)
StrokeCenter.org

Familial Intracranial Aneurysm Study
ClinicalTrials.gov

This information last updated on: 10/5/2009

Reviewed on: 09/29/2009.

UID: 1042

   

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