Trial document




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  DRKS00003198

Trial Description

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Title

Perfusion imaging by arterial spin labelling for clinical use in stroke

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Trial Acronym

PEGASUS

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URL of the Trial

[---]*

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Brief Summary in Lay Language

The study compares two different methods for measuring the perfusion of the brain with magnetic resonance imaging in patiens with stroke or a stenosis of arteries supplying the brain. It should be investigated if the new method (ASL) yields comparable results as the estabished method (PWI).

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Brief Summary in Scientific Language

The study compares two different MRI-sequences ASL (arterial spin labelling) and PWI (perfusion weighted imaging) measuring the cerebral blood flow (CBF). It should be investigated if ASL yields comparable results as PWI in patients with different cerebrovascular pathologies.

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Organizational Data

  •   DRKS00003198
  •   2011/08/12
  •   [---]*
  •   yes
  •   Approved
  •   EA2/086/11, Ethik-Kommission der Charité -Universitätsmedizin Berlin-
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Secondary IDs

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Health Condition or Problem studied

  •   I65.2 -  Occlusion and stenosis of carotid artery
  •   I66.0 -  Occlusion and stenosis of middle cerebral artery
  •   I63.2 -  Cerebral infarction due to unspecified occlusion or stenosis of precerebral arteries
  •   I63.5 -  Cerebral infarction due to unspecified occlusion or stenosis of cerebral arteries
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Interventions/Observational Groups

  •   Patients undergo MRI with ASL and PWI respectively
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Characteristics

  •   Non-interventional
  •   Other
  •   Single arm study
  •   Open (masking not used)
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  •   Uncontrolled/Single arm
  •   Diagnostic
  •   Single (group)
  •   N/A
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Primary Outcome

CBF (crebral blood flow) in an outlined region of interest (ROI) measured by ASL (arterial spin labelling) and PWI (perfusion weighted imaging)

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Secondary Outcome

N.A.

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Countries of Recruitment

  •   Germany
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Locations of Recruitment

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Recruitment

  •   Actual
  •   2011/08/05
  •   81
  •   Monocenter trial
  •   National
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Inclusion Criteria

  •   Both, male and female
  •   18   Years
  •   90   Years
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Additional Inclusion Criteria

In-patient or out-patient, neurologically or hemodynamically stable state, one of the following cerebrovascular pathologies:

High grade stenosis (>70%) of the common carotid artery,

High grade stenosis (>70%) of the internal extracranial carotid artery,

High grade stenosis (>70%) of the internal intracranial carotid artery,

High grade stenosis (>70%) of the middle cerebral artery, proximal part M1,

High grade stenosis (>70%) of the middle cerebral artery, distal parts M2/M3.

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Exclusion Criteria

MR-contraindications, patients with magnetic implants (pacemaker), claustrophobia, clinically unstable status, unability to give informed consent due to aphasia or reduced vigilance, allergic reaction to gadolinium-based contrast agents, renal insufficiency (GFR ≤ 30 ml/min/1,73 m²), pregnancy

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Addresses

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    • Charité Campus Charité Mitte
    • Charitéplatz 1
    • 10117  Berlin
    • Germany
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    • CSB-Centrum für Schlaganfallforschung
    • Mr.  Univ.-Prof. Dr.  Jan  Sobesky 
    • Charitéplatz1
    • 11017  Berlin
    • Germany
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    • CSB-Centrum für Schlaganfallforschung
    • Mr.  Univ.-Prof. Dr.  Jan  Sobesky 
    • Charitéplatz1
    • 11017  Berlin
    • Germany
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Sources of Monetary or Material Support

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    • Bundesministerium für Bildung und Forschung
    • Hannoversche Straße 28-30
    • 10115   Berlin
    • Germany
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    •   [---]*
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Status

  •   Recruiting ongoing
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Trial Publications, Results and other Documents

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