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

June 23, 2014 updated by: Jochen B. Fiebach, Charite University, Berlin, Germany

3T Stroke MRT for Examining Mismatch in the CSB of the Charité Universitätsmedizin Berlin (3Tesla in 1000+)

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.

Study Overview

Status

Completed

Conditions

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

Enrollment (Actual)

1500

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • Germany
      • Berlin, Germany, 12200
        • Center for Stroke Research Berlin, Neurology, Charité Campus Benjamin Franklin

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years and older (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

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

Description

Inclusion Criteria:

  • Suspected stroke or TIA within 24 hours from symptom onset

Exclusion Criteria:

  • MRI contraindication

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Time Frame
change of infarct size between baseline and day 6
Time Frame: day 6
day 6

Secondary Outcome Measures

Outcome Measure
Time Frame
clinical score (modified Rankin Scale)
Time Frame: day 90
day 90

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Charite University, Berlin, Germany

Collaborators

German Federal Ministry of Education and Research

Investigators

  • Principal Investigator: Jochen B. Fiebach, MD, Center for Stroke Research Berlin, Charité, Universitätsmedizin Berlin, Neurology

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

July 1, 2008

Primary Completion (Actual)

July 1, 2013

Study Completion (Actual)

July 1, 2013

Study Registration Dates

First Submitted

July 11, 2008

First Submitted That Met QC Criteria

July 11, 2008

First Posted (Estimate)

July 15, 2008

Study Record Updates

Last Update Posted (Estimate)

June 24, 2014

Last Update Submitted That Met QC Criteria

June 23, 2014

Last Verified

June 1, 2014

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • CCBF-1000+
  • 4-026-08 (Other Identifier: Ethics Committee Charité)

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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