- ICH GCP
- Registre américain des essais cliniques
- Essai clinique NCT00071565
Familial Intracranial Aneurysm Study II
Aperçu de l'étude
Statut
Les conditions
Description détaillée
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.
Type d'étude
Inscription (Réel)
Contacts et emplacements
Lieux d'étude
-
-
Alabama
-
Birmingham, Alabama, États-Unis, 35294
- University of Alabama
-
-
California
-
San Francisco, California, États-Unis, 94143-0114
- University of California,
-
-
Florida
-
Gainesville, Florida, États-Unis, 32610-0265
- University of Florida
-
-
Indiana
-
Indianapolis, Indiana, États-Unis, 46202
- Indianapolis Neurosurgical Group
-
-
Maryland
-
Baltimore, Maryland, États-Unis, 21287
- Johns Hopkins University School of Medicine
-
Baltimore, Maryland, États-Unis, 21201-1595
- University of Maryland
-
-
Massachusetts
-
Boston, Massachusetts, États-Unis, 02115
- Brigham & Women's Hospital
-
Boston, Massachusetts, États-Unis, 02114-2698
- Massachusetts General Hospital
-
-
Michigan
-
Ann Arbor, Michigan, États-Unis, 48109-0489
- University of Michigan
-
-
Minnesota
-
Rochester, Minnesota, États-Unis, 55905
- Mayo Clinic
-
-
Missouri
-
St. Louis, Missouri, États-Unis, 63110
- Washington University
-
-
New York
-
New York, New York, États-Unis, 10032
- Columbia University,
-
-
Ohio
-
Cincinnati, Ohio, États-Unis, 45267
- University of Cincinnati, Department of Neurology
-
-
Pennsylvania
-
Pittsburgh, Pennsylvania, États-Unis, 15212
- Allegheny General Hospital
-
-
Virginia
-
Charlottesville, Virginia, États-Unis, 22903
- University of Virginia
-
-
Washington
-
Seattle, Washington, États-Unis, 98104
- University of Washington
-
-
Critères de participation
Critère d'éligibilité
Âges éligibles pour étudier
Accepte les volontaires sains
Sexes éligibles pour l'étude
Méthode d'échantillonnage
Population étudiée
La description
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.
Plan d'étude
Comment l'étude est-elle conçue ?
Détails de conception
Cohortes et interventions
Groupe / Cohorte |
---|
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
|
Collaborateurs et enquêteurs
Parrainer
Les enquêteurs
- Chercheur principal: Joseph P. Broderick, M.D., University of Cincinnati
Publications et liens utiles
Dates d'enregistrement des études
Dates principales de l'étude
Début de l'étude
Achèvement primaire (Réel)
Achèvement de l'étude (Réel)
Dates d'inscription aux études
Première soumission
Première soumission répondant aux critères de contrôle qualité
Première publication (Estimation)
Mises à jour des dossiers d'étude
Dernière mise à jour publiée (Estimation)
Dernière mise à jour soumise répondant aux critères de contrôle qualité
Dernière vérification
Plus d'information
Termes liés à cette étude
Mots clés
Termes MeSH pertinents supplémentaires
- Processus pathologiques
- Maladies cardiovasculaires
- Maladies vasculaires
- Troubles cérébrovasculaires
- Maladies du cerveau
- Maladies du système nerveux central
- Maladies du système nerveux
- Maladies artérielles intracrâniennes
- Hémorragies intracrâniennes
- Hémorragie
- Anévrisme
- Hémorragie sous-arachnoïdienne
- Anévrisme intracrânien
Autres numéros d'identification d'étude
- R01NS039512 (Subvention/contrat des NIH des États-Unis)
- R01NS039512-06A1 (Subvention/contrat des NIH des États-Unis)
Ces informations ont été extraites directement du site Web clinicaltrials.gov sans aucune modification. Si vous avez des demandes de modification, de suppression ou de mise à jour des détails de votre étude, veuillez contacter register@clinicaltrials.gov. Dès qu'un changement est mis en œuvre sur clinicaltrials.gov, il sera également mis à jour automatiquement sur notre site Web .