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

Acute Stroke Clinical Trial

— 1000Plus  

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT00715533
• Other study ID #: CCBF-1000+
• Secondary ID: 4-026-08
• Status: Completed
• Phase: N/A
• First received: July 11, 2008
• Last updated: June 23, 2014
• Start date: July 2008
• Est. completion date: July 2013

Study information

• Verified date: June 2014
• Source: Charite University, Berlin, Germany
• Contact: n/a
• Is FDA regulated: No
• Health authority: Germany: Ethics Commission
• Study type: Observational

Clinical Trial 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.

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

Recruitment information / eligibility

• Status: Completed
• Enrollment: 1500
• Est. completion date: July 2013
• Est. primary completion date: July 2013
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 18 Years and older

Eligibility

Inclusion Criteria:

• Suspected stroke or TIA within 24 hours from symptom onset

Exclusion Criteria:

• MRI contraindication

Study Design

Observational Model: Cohort, Time Perspective: Prospective

Related Conditions & MeSH terms

• Acute Stroke
• Ischemic Attack, Transient
• Stroke
• Transient Ischemic Attack

Locations

Country	Name	City	State
Germany	Center for Stroke Research Berlin, Neurology, Charité Campus Benjamin Franklin	Berlin

Sponsors (2)

Lead Sponsor	Collaborator
Charite University, Berlin, Germany	German Federal Ministry of Education and Research

Country where clinical trial is conducted

Germany, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	change of infarct size between baseline and day 6		day 6	No
Secondary	clinical score (modified Rankin Scale)		day 90	No