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PubMed
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Stroke Interventions in Clinical Trials
Printable Version
FIA
Familial Intracranial Aneurysm Study (Phase I)



Principal Investigator
Joseph Broderick, M.D.

PI Address
University of Cincinnati
231 Albert Sabin Way
Cincinnati, OH 45267-0525

Phone: 513-558-2957

Contact Address
Laura Sauerbeck
University of Cincinnati
260 Stetson Ave, Suite 2300
Cincinnati, Ohio 45267-0525
Phone: 513-558-1742
Jeanne Sester
Email: sesterrj@UCMAIL.UC.EDU

Contact Email
SAUERBLR@UCMAIL.UC.EDU

Sponsor



Study Size Actual:2847
Study Size Planned:3200
Centers Actual:36
Centers Planned:25
Min Age:18
ISRCTN#NCT00071565
Status:
Phase I is active for follow-up only.

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):
US, Canada, New Zealand, Australia

Year Started: 2002
Year Finished: 2009
Year Published: 2008


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

Inclusion Criteria
Two or more affected pairs of siblings (brothers/sisters) or 3 or more family members affected with intracerebral aneurysms. Eligible families include: 1) Families with at least 2 living affected siblings, 2) Families with at least 2 affected siblings, one is living and the other whose genotype can be reconstructed, 3) Families with ≥ 3 affected non-sibling family members, two of whom both alive and have living connecting relatives, and 4) Families with > 3 affected, with one living and at least one other affected relative whose genotype can be reconstructed.

Exclusion Criteria
History of polycystic kidney disease, Marfan’s Syndrome, Ehler Danlos Syndrome, or fibromuscular dyslpasia.

Patient Involvement:
Participants will be asked to complete a family history questionnaire and a medical history questionnaire. They will also have their blood pressure measured and will give a small sample of blood. In addition, certain family members will be offered the opportunity to undergo a Magnetic Resonance Angiography MRA (a non-invasive diagnostic test) to look for undiagnosed brain aneurysms.
Additionally, participants will be contacted by mail on a yearly basis to evaluate their health, and to determine if any other family members have developed intracranial aneurysms.

Primary Outcome:
SNP genotyping; nonparametric (allele sharing) linkage analysis, including environmental risk factors is conducted; and fine gene mapping will be performed.

Results:
Phase I completed in 2009 and Phase II started.

Comments:
546 families have been enrolled--the genome screening had been run on 395 families as of December 2007. Investigators have submitted to the NIH a continuation grant named FIA II to enroll an additional 300 families (status pending).

Source of Information:
Direct correspondence with trial coordinators.
Presented at the 30th International Stroke Conference [February 2005].
Presented at the 2006 International Stroke Conference [February 2006].
ClinicalTrials.gov
Presented at the 2007 International Stroke Conference [February 2007].

Web Links and Publications:
FIA Web Site - University of Cincinnati

Genome screen to detect linkage to intracranial aneurysm susceptibility genes: the Familial Intracranial Aneurysm (FIA) study.
Stroke 2008 May;39(5):1434-40

Screening for brain aneurysm in the Familial Intracranial Aneurysm study: frequency and predictors of lesion detection.
J Neurosurg 2008 Jun;108(6):1132-1138

The Familial Intracranial Aneurysm (FIA) study protocol.
BMC Med Genet 2005 Apr 26;6:17

Presentations and Publications for FIA

Familial Intracranial Aneurysm Study (phase II)
StrokeCenter.org

Familial Intracranial Aneurysm Study
ClinicalTrials.gov

This information last updated on: 10/5/2009

Reviewed on: 09/29/2009.

UID: 472

   

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