Clinical Trial: Giant Intracranial Aneurysm Registry
Study Status: Recruiting
Recruit Status: Unknown status
Study Type: Observational [Patient Registry]
Official Title: Giant Intracranial Aneurysm Registry
Brief Summary: The purpose of this study is to generate detailed insight into which therapies of giant intracranial aneurysms are being conducted, to document the natural history and the outcome of treatment over 5 years after inclusion into the Registry and to follow imaging data of giant aneurysms over years after diagnosis.
Detailed Summary:
Definition of aims, eligibility of patients and data flow
In August 2009 a steering committee was appointed and its first meeting took place in Berlin. Here the aims of the registry were defined as follows: 1) To generate detailed insight into which therapies are being conducted. 2) To document the natural history of patients and follow it over years after diagnosis. 3) To follow imaging data of giant aneurysms over years after diagnosis, whether treated conservatively or not. 4) To expand the register into several disciplines (by inviting neuroradiologic and neurologic centers to join) and internationally.
Inclusion criteria are a) the diagnosis of a giant intracranial aneurysm by CT, MRI or regular angiography, b) age 18 years and older and c) informed consent. There are no exclusion criteria. If a patient is not able to give informed consent due to his or her clinical situation, the legal representative of the patient (e.g. family member) will be informed and asked to sign the consent form on behalf of the patient.
Patients are recruited consecutively in responsibility of each center. In addition to the prospective part there is a retrospective part in which patients are included that were admitted after January 2006. Data are gathered at admission, discharge and 1/3/5 years after discharge. Starting from February 2010 a 9-month pilot phase was conducted in order to identify and correct possible problems of data acquisition.
Development of a study protocol
Relevant variables were discussed on the basis of existing literature on giant intracranial aneurysms. All variables were chosen so that they can be determined in a routine clinical context even in small centers with min
Sponsor: Dr. med. Julius Dengler
Current Primary Outcome: aneurysm rupture rate - diagnosed radiologically (e.g. by CT) or clinically [ Time Frame: 5 years ]
Original Primary Outcome: aneurysm rupture rate [ Time Frame: 5 years ]
Current Secondary Outcome: health status of the patient quantified by modified Rankin Scale in combination with a basic neurological exam [ Time Frame: 5 years ]
Original Secondary Outcome: health status of the patient [ Time Frame: 5 years ]
Information By: Charite University, Berlin, Germany
Dates:
Date Received: February 17, 2014
Date Started: December 2008
Date Completion: January 2016
Last Updated: February 18, 2014
Last Verified: February 2014
