3 Tesla (3T) Stroke Medical Radiologic Technology (MRT) for Examining Mismatch in 1000+ (1000Plus)

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details. Identifier: NCT00715533
Recruitment Status : Completed
First Posted : July 15, 2008
Last Update Posted : June 24, 2014
German Federal Ministry of Education and Research
Information provided by (Responsible Party):
Jochen B. Fiebach, Charite University, Berlin, Germany

Brief Summary:
The purpose of this study is to compare clinical and economic parameters of stroke patients who have received acute MRI imaging (test group) to patients who have received routine CT imaging (control group) in the clinical setting of acute stroke.

Condition or disease
Acute Stroke Transient Ischemic Attack

Detailed Description:

The primary objective:

  • Prospective validation of infarct development in ischemic stroke and transitory ischemic attacks on the basis of all patients given a preliminary diagnosis of stroke or TIA in the emergency ward of the Benjamin Franklin Campus of Charité-Universitätsmedizin Berlin.

Secondary objectives:

  • Determination of the spontaneous reperfusion rate in patients with an initial mismatch in the correlation between the time from onset of symptoms to the time of first imaging and NIHSS score severity
  • Characterization of metabolic changes in ischemic tissue in cases of minor subcortical infarct using high resolution diffusion weighted MRI (DWI) and perfusion MRI with 2nd pass corrected CBF cards
  • Proof of the principle that stroke MRI can improve patient care / shorten the period in which patients are bedridden
  • Measurement of the diffusion tensor in acute ischemic stroke (Hamburg DTI study)
  • Proof of structural damage and investigation of pathogenesis in patients suffering from clinical transitory ischemic attacks (TIA)
  • Investigation of the correlation of clinical symptoms and lesion site as well as of changes in cortical plasticity in patients with solitary thalamus infarct
  • Brain plasticity and motor learning in cases of a purely cortical infarct
  • Characterization of gender specific damage patterns in stroke
  • Morphologic and pathophysiological typing of the cryptic and cardial embolic infarct in correlation to incidence of arrhythmia
  • Characterization of localization and morphology of infarcts in patients presenting in the emergency ward with central vestibular nerve syndrome / recording frequency of cerebral sessions in patients presenting with a primary diagnosis of central vestibular nerve lesion
  • Clinical characterization of cerebellar and brain stem infarcts which are accompanied by vertigo symptoms and their correlation to infarct location

Study Type : Observational
Actual Enrollment : 1500 participants
Observational Model: Cohort
Time Perspective: Prospective
Official Title: 3T Stroke MRT for Examining Mismatch in the CSB of the Charité Universitätsmedizin Berlin (3Tesla in 1000+)
Study Start Date : July 2008
Actual Primary Completion Date : July 2013
Actual Study Completion Date : July 2013

Primary Outcome Measures :
  1. change of infarct size between baseline and day 6 [ Time Frame: day 6 ]

Secondary Outcome Measures :
  1. clinical score (modified Rankin Scale) [ Time Frame: day 90 ]

Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years and older   (Adult, Senior)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Sampling Method:   Non-Probability Sample
Study Population
Primary care clinic. Patients presenting with acute (< 24 h) transient ischemic attack or stroke at the emergency ward, Campus Benjamin Franklin

Inclusion Criteria:

  • Suspected stroke or TIA within 24 hours from symptom onset

Exclusion Criteria:

  • MRI contraindication

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its identifier (NCT number): NCT00715533

Center for Stroke Research Berlin, Neurology, Charité Campus Benjamin Franklin
Berlin, Germany, 12200
Sponsors and Collaborators
Charite University, Berlin, Germany
German Federal Ministry of Education and Research
Principal Investigator: Jochen B. Fiebach, MD Center for Stroke Research Berlin, Charité, Universitätsmedizin Berlin, Neurology

Publications automatically indexed to this study by Identifier (NCT Number):

Responsible Party: Jochen B. Fiebach, MD, Charite University, Berlin, Germany Identifier: NCT00715533     History of Changes
Other Study ID Numbers: CCBF-1000+
First Posted: July 15, 2008    Key Record Dates
Last Update Posted: June 24, 2014
Last Verified: June 2014

Keywords provided by Jochen B. Fiebach, Charite University, Berlin, Germany:
acute (< 24 hours) stroke

Additional relevant MeSH terms:
Ischemic Attack, Transient
Cerebrovascular Disorders
Brain Diseases
Central Nervous System Diseases
Nervous System Diseases
Vascular Diseases
Cardiovascular Diseases
Brain Ischemia