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Familial Intracranial Aneurysm Study II

17 agosto 2015 aggiornato da: Joseph Broderick, University of Cincinnati

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.

Panoramica dello studio

Stato

Completato

Condizioni

Descrizione dettagliata

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.

Tipo di studio

Osservativo

Iscrizione (Effettivo)

5875

Contatti e Sedi

Questa sezione fornisce i recapiti di coloro che conducono lo studio e informazioni su dove viene condotto lo studio.

Luoghi di studio

Stati Uniti
- Alabama
  - Birmingham, Alabama, Stati Uniti, 35294
    - University of Alabama
- California
  - San Francisco, California, Stati Uniti, 94143-0114
    - University of California,
- Florida
  - Gainesville, Florida, Stati Uniti, 32610-0265
    - University of Florida
- Indiana
  - Indianapolis, Indiana, Stati Uniti, 46202
    - Indianapolis Neurosurgical Group
- Maryland
  - Baltimore, Maryland, Stati Uniti, 21287
    - Johns Hopkins University School Of Medicine
  - Baltimore, Maryland, Stati Uniti, 21201-1595
    - University of Maryland
- Massachusetts
  - Boston, Massachusetts, Stati Uniti, 02115
    - Brigham & Women's Hospital
  - Boston, Massachusetts, Stati Uniti, 02114-2698
    - Massachusetts General Hospital
- Michigan
  - Ann Arbor, Michigan, Stati Uniti, 48109-0489
    - University of Michigan
- Minnesota
  - Rochester, Minnesota, Stati Uniti, 55905
    - Mayo Clinic
- Missouri
  - St. Louis, Missouri, Stati Uniti, 63110
    - Washington University
- New York
  - New York, New York, Stati Uniti, 10032
    - Columbia University,
- Ohio
  - Cincinnati, Ohio, Stati Uniti, 45267
    - University of Cincinnati, Department of Neurology
- Pennsylvania
  - Pittsburgh, Pennsylvania, Stati Uniti, 15212
    - Allegheny General Hospital
- Virginia
  - Charlottesville, Virginia, Stati Uniti, 22903
    - University of Virginia
- Washington
  - Seattle, Washington, Stati Uniti, 98104
    - University of Washington

Criteri di partecipazione

I ricercatori cercano persone che corrispondano a una certa descrizione, chiamata criteri di ammissibilità. Alcuni esempi di questi criteri sono le condizioni generali di salute di una persona o trattamenti precedenti.

Criteri di ammissibilità

Età idonea allo studio

13 anni e precedenti (Bambino, Adulto, Adulto più anziano)

Accetta volontari sani

Sì

Sessi ammissibili allo studio

Tutto

Metodo di campionamento

Campione non probabilistico

Popolazione di studio

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.

Descrizione

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.

Piano di studio

Questa sezione fornisce i dettagli del piano di studio, compreso il modo in cui lo studio è progettato e ciò che lo studio sta misurando.

Come è strutturato lo studio?

Dettagli di progettazione

Numero di gruppi/coorti

Coorti e interventi

Gruppo / Coorte
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

Collaboratori e investigatori

Qui è dove troverai le persone e le organizzazioni coinvolte in questo studio.

Sponsor

University of Cincinnati

Collaboratori

National Institute of Neurological Disorders and Stroke (NINDS)

Investigatori

Investigatore principale: Joseph P. Broderick, M.D., University of Cincinnati

Pubblicazioni e link utili

La persona responsabile dell'inserimento delle informazioni sullo studio fornisce volontariamente queste pubblicazioni. Questi possono riguardare qualsiasi cosa relativa allo studio.

Pubblicazioni generali

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.

Studiare le date dei record

Queste date tengono traccia dell'avanzamento della registrazione dello studio e dell'invio dei risultati di sintesi a ClinicalTrials.gov. I record degli studi e i risultati riportati vengono esaminati dalla National Library of Medicine (NLM) per assicurarsi che soddisfino specifici standard di controllo della qualità prima di essere pubblicati sul sito Web pubblico.

Studia le date principali

Inizio studio

1 settembre 2002

Completamento primario (Effettivo)

1 maggio 2015

Completamento dello studio (Effettivo)