3 Tesla (3T) Stroke Medical Radiologic Technology (MRT) f... | NCT00715533

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

NCT00715533

Sponsor

Charite University, Berlin, Germany

Status

Completed

Last Update Posted

Jun 24, 2014Estimated

Enrollment

1,500Actual

Phase

Not provided

Conditions

Acute Stroke
Transient Ischemic Attack

Interventions

Not provided

Countries

Germany

Protocol Section

Identification Module Status Module Sponsor/Collaborators Module Oversight Module Description Module Conditions Module Design Module Arms/Interventions Module Outcomes Module Eligibility Module Contacts/Locations Module References Module IPD Sharing Statement Module

Results Section

Participant Flow Module Baseline Characteristics Module Outcome Measures Module Adverse Events Module More Info Module

Annotation Section

Annotation Module

Document Section

Large Document Module

Derived Section

Miscellaneous Info Module Condition Browse Module Intervention Browse Module

Protocol Section

Identification Module

NCT ID

Results Section

No data available

No data is available for this block.

Annotation Section

No data available

No data is available for this block.

Document Section

No data available

No data is available for this block.

Derived Section

Miscellaneous Info Module

Version Holder

ID	Type	Description	Link
4-026-08

Status Module

Record Verification Date

Jun 2014

Overall Recruitment Status or Expanded Access Status

Completed

Last Known Status

Not provided

Delayed Posting

Not provided

Why Stopped

Not provided

Expanded Access Info

Start Date

Jul 2008

Primary Completion Date

Jul 2013Actual

Completion Date

Jul 2013Actual

First Submitted Date

Jul 11, 2008

First Submission Date that Met QC Criteria

Jul 11, 2008

First Posted Date

Jul 15, 2008Estimated

Results Waived

Not provided

Results First Submitted Date

Not provided

Results First Submitted that Met QC Criteria

Not provided

Results First Posted Date

Not provided

Certification/Extension (aka Delayed Results) First Submitted Date

Not provided

Certification/Extension First Submitted that Passed QC Review

Not provided

Certification/Extension First Posted Date

Not provided

Last Update Submitted Date

Jun 23, 2014

Last Update Posted Date

Jun 24, 2014Estimated

Sponsor/Collaborators Module

Responsible Party, by Official Title

Jochen B. Fiebach, MD, Charite University, Berlin, GermanyPrincipal Investigator

Lead Sponsor

Charite University, Berlin, GermanyOTHER

Collaborators

Name	Class
German Federal Ministry of Education and Research	OTHER_GOV

Oversight Module

Has Data Monitoring Committee (DMC)

Is FDA Regulated Drug

Not provided

Is FDA Regulated Device

Not provided

Is Unapproved Device

Not provided

Pediatric Postmarket Surveillance of a Device Product

Not provided

Product Exported from US

Not provided

FDAAA801 Violation

Not provided

Description Module

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.

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

Design Module

Study Type

Observational

Number of References to an Expanded Access Study

Not provided

Expanded Access Types

Not provided

Patient Registry

Not provided

Target Follow-Up Duration

Not provided

Phases

Not provided

Interventional Study Design

Allocation

Not provided

Intervention Model

Biospecimen

No data available

No data is available for this block.

Enrollment

1,500Actual

Outcomes Module

Primary Outcomes

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

Secondary Outcomes

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

Other Outcomes

Not provided

Eligibility Module

Eligibility Criteria

Inclusion Criteria:

Suspected stroke or TIA within 24 hours from symptom onset

Exclusion Criteria:

MRI contraindication

Accepts Healthy Volunteers

Sex

All

Sex/Gender Based

Not provided

Sex/Gender Description

Not provided

Minimum Age

18 Years

Maximum Age

Not provided

Standard Ages

AdultOlder Adult

Study Population

Primary care clinic. Patients presenting with acute (< 24 h) transient ischemic attack or stroke at the emergency ward, Campus Benjamin Franklin

Sampling Method

Non-Probability Sample

Contacts/Locations Module

Central Contacts

Not provided

Overall Officials

Name	Affiliation	Role
Jochen B. Fiebach, MD	Center for Stroke Research Berlin, Charité, Universitätsmedizin Berlin, Neurology	Principal Investigator

Locations

Facility	Status	City	State	ZIP	Country	Contacts
Center for Stroke Research Berlin, Neurology, Charité Campus Benjamin Franklin		Berlin		12200	Germany

References Module

Citations

PubMed Identifier	Type	Citation	Retractions
30828313	Derived	Hotter B, Hoffmann S, Ulm L, Meisel C, Fiebach JB, Meisel A. IL-6 Plasma Levels Correlate With Cerebral Perfusion Deficits and Infarct Sizes in Stroke Patients Without Associated Infections. Front Neurol. 2019 Feb 15;10:83. doi: 10.3389/fneur.2019.00083. eCollection 2019.
29431878	Derived	Villringer K, Florczak-Rzepka M, Grittner U, Brunecker P, Tepe H, Nolte CH, Fiebach JB. Characteristics associated with outcome in patients with first-ever posterior fossa stroke. Eur J Neurol. 2018 Jun;25(6):818-824. doi: 10.1111/ene.13596. Epub 2018 Mar 25.

ID	Term
D020521	Stroke
D002546	Ischemic Attack, Transient

ID	Term
D002561	Cerebrovascular Disorders
D001927	Brain Diseases
D002493	Central Nervous System Diseases
D009422	Nervous System Diseases