Trial document





This study has been imported from ClinicalTrials.gov without additional data checks.
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  DRKS00005858

Trial Description

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Title

Giant Intracranial Aneurysm Registry

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Trial Acronym

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URL of the Trial

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Brief Summary in Lay Language

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.

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Brief Summary in Scientific Language

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 minimal technical equipment. Data collection was decided
to be carried out using a modular structure, consisting of a basic module and additional
modules for specific research questions.

The steering committee decided on the content of a mandatory basic data collection for all
centers. This basic module was designed to keep the amount of variables at a minimum so that
data collection can be conducted as safely and quickly as possible by physicians of all
disciplines. It focuses on the clinical course between initial presentation and discharge
but also includes data on patient history, such as risk factors and possible prior aneurysm
therapy. A neurological examination of cranial nerve functions, motor capability and speech
is conducted initially, at discharge and during 3 mandatory follow-up examinations. At each
examination the patients' physical condition is recorded using internationally accepted and
reliable grading systems. The investigator is asked to not only record a clinical diagnosis,
such as epileptic seizure or incidental finding, but also use imaging data to produce a
radiological diagnosis and characterize the aneurysm regarding its location, size, shape and
structure. The mode of therapy is documented choosing between conservative, surgical and
endovascular options and combinations thereof. Possible complications are recorded as well
as radiologic results of intervention.

Each center is given the option to take part in additional extra modules, which serve as a
basis for spin-off projects resulting from the discussion within the study group. This
comprises for example an imaging module to lead to a better understanding of how giant
intracranial aneurysms develop over time. It will monitor changes in aneurysm configuration
and flow dynamics using 3D-imaging data. A cost module will integrate data on treatment
expenses making it possible to compare the costs of each mode of therapy.

An external review of the study protocol was conducted to ensure high methodological quality
and wide acceptance of the results. For this purpose a preliminary working report was
forwarded to 4 independent experts in the field of neurovascular research. The reviewers
were asked to comment on the appropriateness of the methods, the practicability of our
variables and the coverage of relevant aspects of giant intracranial aneurysm care. The
comments of the external reviewers were gathered and discussed within the steering
committee. Based on the recommendations of the external reviewers, a final revision of the
study protocol took place.

Primary hypothesis, study outcome and statistical analyses

The primary hypothesis of the study is that conservative, endovascular and surgical therapy
result in equal aneurysm rupture rates. Therefore primary outcome will be aneurysm rupture
rate at 5 years of follow up.

The sample size calculation is based on the estimated 5-year cumulative rupture rates for
patients with unruptured giant aneurysm given in the ISUIA-Trial. According to their results
we assume a 5-year rupture rate of 0.30 irrespective of which specific treatment is applied.
Because of a lack of data on special rupture rates regarding patients treated with the three
considered methods, sample size calculation was done for one proportion based on precision
analysis. Consequently, a two-sided 95% confidence interval with a width equal to 0.10 is
achieved by a sample size of 320 patients. For the outcomes death or rupture the
corresponding survival functions with 95% confidence intervals will be estimated by the
Kaplan-Meier method. The null-hypotheses of equal survival curves for two treatment groups
will be tested by the Log-Rank test. With documented dates of rupture events the sample size
of 320 calculated above is sufficient to detect moderate effects of possible predictors for
rupture by Cox proportional hazards regression within a secondary analysis. Furthermore we
can model the logit of rupture after 5 years by binary logistic regression detecting
possible moderate to considerable effects of predictors. Therapy (conventional, surgery or
endovascular) will be the main factor of interest for both multivariable analyses.

Patient recruitment / Data storage / Quality assurance

In 2008 patient recruitment began at the Charité Berlin, one year later data from other
centers were included as well, initially only in Germany, later on throughout Europe and
Japan. Patient data are stored using pseudonyms. Centers can either use a fax-based data
inclusion form or a web-based entry form. All data are stored at the Charité - Berlin. For
quality assurance a monitoring visit to the 7 most-including centers was conducted in 2013.

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Organizational Data

  •   DRKS00005858
  •   2014/08/22
  •   2014/02/17
  •   yes
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Secondary IDs

  •   NCT02066493  (ClinicalTrials.gov)
  •   Giant  (Dr. med. Julius Dengler)
  •   CS-2009-13 
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Health Condition or Problem studied

  •   Intracranial Aneurysms
  •   I67.10 -  message.icd10.coding.redirected.en
  •   Q28 -  Other congenital malformations of circulatory system
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Interventions/Observational Groups

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Characteristics

  •   Non-interventional
  •   Observational study
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  •   N/A
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Primary Outcome

- aneurysm rupture rate - diagnosed radiologically (e.g. by CT) or clinically; time frame: 5 years

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Secondary Outcome

- health status of the patient quantified by modified Rankin Scale in combination with a basic neurological exam; time frame: 5 years

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Countries of Recruitment

  •   Germany
  •   Japan
  •   Switzerland
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Locations of Recruitment

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Recruitment

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  •   2008/12/31
  •   105
  •   Multicenter trial
  •   International
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Inclusion Criteria

  •   Both, male and female
  •   18   Years
  •   no maximum age
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Additional Inclusion Criteria

- diagnosis of a giant intracranial aneurysm

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Exclusion Criteria

- age younger than 18

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Addresses

  • start of 1:1-Block address primary-sponsor
    • Dr. med. Julius Dengler
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    • Charite University, Berlin, Germany
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    • Charité Berlin
    • Julius Dengler, MD 
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    • Julius Dengler, MD 
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Sources of Monetary or Material Support

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    • Bitte wenden Sie sich an den Sponsor / Please refer to primary sponsor
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Status

  •   Recruiting ongoing
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Trial Publications, Results and other Documents

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The parameters in ClinicalTrials.gov and DRKS are not identical. Therefore the data import from ClinicalTrials.gov required adjustments. For full details please see the DRKS FAQs .
  •   2
  •   2014/11/27
* This entry means the parameter is not applicable or has not been set.