NCT00071565

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.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
5,875

participants targeted

Target at P75+ for all trials

Timeline
Completed

Started Sep 2002

Longer than P75 for all trials

Geographic Reach
1 country

16 active sites

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

September 1, 2002

Completed
1.2 years until next milestone

First Submitted

Initial submission to the registry

October 28, 2003

Completed
1 day until next milestone

First Posted

Study publicly available on registry

October 29, 2003

Completed
11.5 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

May 1, 2015

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

May 1, 2015

Completed
Last Updated

August 18, 2015

Status Verified

August 1, 2015

Enrollment Period

12.7 years

First QC Date

October 28, 2003

Last Update Submit

August 17, 2015

Conditions

Keywords

familial intracranial aneurysmintracranial aneurysmbrain aneurysmaneurysmsubarachnoid hemorrhagestroke

Study Arms (1)

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

Eligibility Criteria

Age13 Years+
Sexall
Healthy VolunteersYes
Age GroupsChild (0-17), Adult (18-64), Older Adult (65+)
Sampling MethodNon-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.

You may qualify if:

  • 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.

You may not qualify if:

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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (16)

University of Alabama

Birmingham, Alabama, 35294, United States

Location

University of California,

San Francisco, California, 94143-0114, United States

Location

University of Florida

Gainesville, Florida, 32610-0265, United States

Location

Indianapolis Neurosurgical Group

Indianapolis, Indiana, 46202, United States

Location

University of Maryland

Baltimore, Maryland, 21201-1595, United States

Location

Johns Hopkins University School of Medicine

Baltimore, Maryland, 21287, United States

Location

Massachusetts General Hospital

Boston, Massachusetts, 02114-2698, United States

Location

Brigham & Women's Hospital

Boston, Massachusetts, 02115, United States

Location

University of Michigan

Ann Arbor, Michigan, 48109-0489, United States

Location

Mayo Clinic

Rochester, Minnesota, 55905, United States

Location

Washington University

St Louis, Missouri, 63110, United States

Location

Columbia University,

New York, New York, 10032, United States

Location

University of Cincinnati, Department of Neurology

Cincinnati, Ohio, 45267, United States

Location

Allegheny General Hospital

Pittsburgh, Pennsylvania, 15212, United States

Location

University of Virginia

Charlottesville, Virginia, 22903, United States

Location

University of Washington

Seattle, Washington, 98104, United States

Location

Related Publications (1)

  • Sauerbeck L, Hornung R, Woo D, Moomaw CJ, Anderson C, Connolly ES, Rouleau GA, Brown RD Jr, Broderick JP; FIA Study Investigators. Mortality and causes of death in the Familial Intracranial Aneurysm study. Int J Stroke. 2013 Dec;8(8):696-700. doi: 10.1111/j.1747-4949.2012.00857.x. Epub 2012 Aug 29.

Biospecimen

Retention: SAMPLES WITH DNA

blood sample

MeSH Terms

Conditions

Intracranial AneurysmSubarachnoid HemorrhageAneurysmStroke

Condition Hierarchy (Ancestors)

Intracranial Arterial DiseasesCerebrovascular DisordersBrain DiseasesCentral Nervous System DiseasesNervous System DiseasesVascular DiseasesCardiovascular DiseasesIntracranial HemorrhagesHemorrhagePathologic ProcessesPathological Conditions, Signs and Symptoms

Study Officials

  • Joseph P. Broderick, M.D.

    University of Cincinnati

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
observational
Observational Model
FAMILY BASED
Time Perspective
PROSPECTIVE
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Joseph P. Broderick

Study Record Dates

First Submitted

October 28, 2003

First Posted

October 29, 2003

Study Start

September 1, 2002

Primary Completion

May 1, 2015

Study Completion

May 1, 2015

Last Updated

August 18, 2015

Record last verified: 2015-08

Locations