Trial document




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  DRKS00006129

Trial Description

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Title

Aneurysm Wall Imaging using Gadolinium enhanced 3-Tesla MRI.

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Trial Acronym

[---]*

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URL of the Trial

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Brief Summary in Lay Language

In patients, who suffer from an Aneurysm of the vessels supplying the brain, there is a risk of cerebral hemorrhage, but not in every case. It is known that most aneurysms, that actually burst, show inflammatory changes in the wall. In our study we want to examine the possibility of the discovery of such inflammatory changes using contrast-based magnetic resonance imaging study in more detail.

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Brief Summary in Scientific Language

Examining the possibility of the discovery of the inflammatory changes in the aneurysm wall.

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Organizational Data

  •   DRKS00006129
  •   2014/05/12
  •   [---]*
  •   yes
  •   Approved
  •   164/14, Ethik-Kommission der Albert-Ludwigs-Universität Freiburg
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Secondary IDs

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Health Condition or Problem studied

  •   I67.10 -  message.icd10.coding.redirected.en
  •   I60.1 -  Subarachnoid haemorrhage from middle cerebral artery
  •   I60.2 -  Subarachnoid haemorrhage from anterior communicating artery
  •   I60.3 -  Subarachnoid haemorrhage from posterior communicating artery
  •   I60.4 -  Subarachnoid haemorrhage from basilar artery
  •   I60.5 -  Subarachnoid haemorrhage from vertebral artery
  •   I60.6 -  Subarachnoid haemorrhage from other intracranial arteries
  •   I60.7 -  Subarachnoid haemorrhage from intracranial artery, unspecified
  •   I60.9 -  Subarachnoid haemorrhage, unspecified
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Interventions/Observational Groups

  •   A contrast enhanced MRI examination is performed in a 3-T scanner after exclusion of contraindications to the examination. The test takes about 25 minutes. Before examining a venous access is established. Gadolinium-containing contrast agents (MultiHance, Bracco Imaging, Konstanz) is administered intravenously. The dose is administered adapted to weight. 0.1 mmol / kg body weight will be given.
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Characteristics

  •   Interventional
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  •   Single arm study
  •   Open (masking not used)
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  •   Uncontrolled/Single arm
  •   Diagnostic
  •   Single (group)
  •   N/A
  •   No
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Primary Outcome

Visualisation of the aneurysm wall with sufficient Quality.
Signal intensity of the aneurysm wall before and after contrast medium.
Visualisation of mural thrombosis.

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Secondary Outcome

Clinical picture at presentation.
Histopathological findings when available.

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Countries of Recruitment

  •   Germany
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Locations of Recruitment

  • University Medical Center 
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Recruitment

  •   Actual
  •   2014/05/12
  •   50
  •   Monocenter trial
  •   National
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Inclusion Criteria

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

1. Age ≥ 18 years.
2. Conventional, computed tomographic (CTA) or magnetic resonance angiography (MRA) demonstrating an intracranial aneurysm.

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Exclusion Criteria

1. Patients with a known contraindication to MRI, e.g. pacemaker, metallic foreign body, or severe claustrophobia.
2. Patients with a known contraindication to Gadolinium contrast agents, e.g. previous moderate to severe allergic reaction or glomerular filtration rate < 60 ml/min/1.73 m².
3. Patients needing sedation to achieve motion-artefact free images.

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Addresses

  • start of 1:1-Block address primary-sponsor
    • Klinik für Neuroradiologie.
    • Mr.  Dr. med.  Samer  Elshikh 
    • Breisacherstr. 64
    • 79106  Freiburg
    • Germany
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    • Klinik für Neuroradiologie. Universitätsklinik Freiburg.
    • Mr.  Dr. med.  Samer  Elsheikh 
    • Breisacherstr. 64
    • 79106  Freiburg
    • Germany
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    • Klinik für Neuroradiologie. Universitätsklinik Freiburg
    • Mr.  Dr. med.   Samer  Elshikh 
    • Breisacherstr. 64
    • 79106  Freiburg
    • Germany
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Sources of Monetary or Material Support

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    • Klinik für Neuroradiologie. Universitätsklinik-Freiburg.
    • Mr.  Dr. med.  Samer  Elsheikh 
    • Breisacherstr 64
    • 79106  Freiburg
    • Germany
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    • Bracco Imaging s.p.a
    • 20134  Milan
    • Italy
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Status

  •   Recruiting complete, follow-up complete
  •   2017/05/30
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Trial Publications, Results and other Documents

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* This entry means the parameter is not applicable or has not been set.