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

This study has been completed.
Sponsor:
Collaborator:
German Federal Ministry of Education and Research
Information provided by (Responsible Party):
Jochen B. Fiebach, Charite University, Berlin, Germany
ClinicalTrials.gov Identifier:
NCT00715533
First received: July 11, 2008
Last updated: June 23, 2014
Last verified: June 2014
  Purpose

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
Acute Stroke
Transient Ischemic Attack

Study Type: Observational
Study Design: 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+)

Resource links provided by NLM:


Further study details as provided by Charite University, Berlin, Germany:

Primary Outcome Measures:
  • change of infarct size between baseline and day 6 [ Time Frame: day 6 ] [ Designated as safety issue: No ]

Secondary Outcome Measures:
  • clinical score (modified Rankin Scale) [ Time Frame: day 90 ] [ Designated as safety issue: No ]

Enrollment: 1500
Study Start Date: July 2008
Study Completion Date: July 2013
Primary Completion Date: July 2013 (Final data collection date for primary outcome measure)
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
  Eligibility

Ages Eligible for Study:   18 Years and older
Genders Eligible for Study:   Both
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

Criteria

Inclusion Criteria:

  • Suspected stroke or TIA within 24 hours from symptom onset

Exclusion Criteria:

  • MRI contraindication
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT00715533

Locations
Germany
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
Investigators
Principal Investigator: Jochen B. Fiebach, MD Center for Stroke Research Berlin, Charité, Universitätsmedizin Berlin, Neurology
  More Information

No publications provided by Charite University, Berlin, Germany

Additional publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):
Responsible Party: Jochen B. Fiebach, MD, Charite University, Berlin, Germany
ClinicalTrials.gov Identifier: NCT00715533     History of Changes
Other Study ID Numbers: CCBF-1000+, 4-026-08
Study First Received: July 11, 2008
Last Updated: June 23, 2014
Health Authority: Germany: Ethics Commission

Keywords provided by Charite University, Berlin, Germany:
acute (< 24 hours) stroke
stroke
TIA
MRI
imaging
acute

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

ClinicalTrials.gov processed this record on September 22, 2014