ClinicalTrials.gg
Sign In
CompletedNCT007155331000PlusUpdated Jun 24, 2014

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

An observational study in Acute Stroke and Transient Ischemic Attack, sponsored by Charite University, Berlin, Germany. Completed at 1 site in Germany. Open to participants aged 18 Years and older. Per ClinicalTrials.gov, last updated 2014-06-24.

Sponsored by Charite University, Berlin, Germany · Observational

Study type
Observational
Model
Cohort
Time perspective
Prospective
Enrollment
1,500
Ages
18 Years and older
Sex
All
01

Study 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.

Read the 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
02

Conditions studied

  • Acute Stroke
  • Transient Ischemic Attack

Keywords

  • acute (< 24 hours) stroke
  • stroke
  • TIA
  • MRI
  • imaging
  • acute
03

In context

Stroke

7,441 studies on the registry are indexed under Stroke; 2,012 are open to participants now.

This study's enrollment of 1,500 is above the median of 160 across 1,729 observational studies indexed under Stroke.

Browse Stroke studies →

Lead sponsor

Charite University, Berlin, Germany is the lead sponsor of 854 studies on the registry; 127 are open to participants now.

Browse Charite University, Berlin, Germany studies →

Counted across the registry records on this site, refreshed daily.

04

Who can participate

Ages eligible
18 Years and older
Sexes eligible
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

Go through the criteria one by one — yes, no or not sure — and take the list to your doctor or the study team. Kept in this browser only.

Inclusion criteria

  • Suspected stroke or TIA within 24 hours from symptom onset

Exclusion criteria

Exclusion Criteria:

  • MRI contraindication
05

Study design

Observational model
Cohort
Time perspective
Prospective
Enrollment
1,500 participants (actual)
06

What researchers measure

Primary outcomes

  1. change of infarct size between baseline and day 6

    Time frame: day 6

Secondary outcomes

  1. clinical score (modified Rankin Scale)

    Time frame: day 90

07

Study locations

1 site
  • Center for Stroke Research Berlin, Neurology, Charité Campus Benjamin Franklin
    Berlin, 12200, Germany
08

References and documents

Publications

  • 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. PubMed 30828313 ↗
  • 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. PubMed 29431878 ↗
  • Braemswig TB, Nolte CH, Fiebach JB, Usnich T. Early New Ischemic Lesions Located Outside the Initially Affected Vascular Territory Appear More Often in Stroke Patients with Elevated Glycated Hemoglobin (HbA1c). Front Neurol. 2017 Nov 14;8:606. doi: 10.3389/fneur.2017.00606. eCollection 2017. PubMed 29184532 ↗
  • Khalil AA, Ostwaldt AC, Nierhaus T, Ganeshan R, Audebert HJ, Villringer K, Villringer A, Fiebach JB. Relationship Between Changes in the Temporal Dynamics of the Blood-Oxygen-Level-Dependent Signal and Hypoperfusion in Acute Ischemic Stroke. Stroke. 2017 Apr;48(4):925-931. doi: 10.1161/STROKEAHA.116.015566. Epub 2017 Mar 8. PubMed 28275197 ↗
  • Villringer K, Sanz Cuesta BE, Ostwaldt AC, Grittner U, Brunecker P, Khalil AA, Schindler K, Eisenblatter O, Audebert H, Fiebach JB. DCE-MRI blood-brain barrier assessment in acute ischemic stroke. Neurology. 2017 Jan 31;88(5):433-440. doi: 10.1212/WNL.0000000000003566. Epub 2016 Dec 28. PubMed 28031392 ↗
  • Hanne L, Brunecker P, Grittner U, Endres M, Villringer K, Fiebach JB, Ebinger M. Right insular infarction and mortality after ischaemic stroke. Eur J Neurol. 2017 Jan;24(1):67-72. doi: 10.1111/ene.13131. Epub 2016 Sep 19. PubMed 27647694 ↗
  • Fiebach JB, Stief JD, Ganeshan R, Hotter B, Ostwaldt AC, Nolte CH, Villringer K. Reliability of Two Diameters Method in Determining Acute Infarct Size. Validation as New Imaging Biomarker. PLoS One. 2015 Oct 8;10(10):e0140065. doi: 10.1371/journal.pone.0140065. eCollection 2015. PubMed 26447761 ↗
  • Hotter B, Ostwaldt AC, Levichev-Connolly A, Rozanski M, Audebert HJ, Fiebach JB. Natural course of total mismatch and predictors for tissue infarction. Neurology. 2015 Sep 1;85(9):770-5. doi: 10.1212/WNL.0000000000001889. Epub 2015 Jul 31. PubMed 26231256 ↗
  • Villringer K, Grittner U, Schaafs LA, Nolte CH, Audebert H, Fiebach JB. IV t-PA influences infarct volume in minor stroke: a pilot study. PLoS One. 2014 Oct 28;9(10):e110477. doi: 10.1371/journal.pone.0110477. eCollection 2014. PubMed 25350762 ↗
  • Grosse-Dresselhaus F, Galinovic I, Villringer K, Audebert HJ, Fiebach JB. Difficulty of MRI based identification of lesion age by acute infra-tentorial ischemic stroke. PLoS One. 2014 Mar 20;9(3):e92868. doi: 10.1371/journal.pone.0092868. eCollection 2014. PubMed 24651570 ↗
  • Rozanski M, Richter TB, Grittner U, Endres M, Fiebach JB, Jungehulsing GJ. Elevated levels of hemoglobin A1c are associated with cerebral white matter disease in patients with stroke. Stroke. 2014 Apr;45(4):1007-11. doi: 10.1161/STROKEAHA.114.004740. Epub 2014 Feb 25. PubMed 24569817 ↗
  • Albach FN, Brunecker P, Usnich T, Villringer K, Ebinger M, Fiebach JB, Nolte CH. Complete early reversal of diffusion-weighted imaging hyperintensities after ischemic stroke is mainly limited to small embolic lesions. Stroke. 2013 Apr;44(4):1043-8. doi: 10.1161/STROKEAHA.111.676346. Epub 2013 Feb 28. PubMed 23449267 ↗
  • Kufner A, Nolte CH, Galinovic I, Brunecker P, Kufner GM, Endres M, Fiebach JB, Ebinger M. Smoking-thrombolysis paradox: recanalization and reperfusion rates after intravenous tissue plasminogen activator in smokers with ischemic stroke. Stroke. 2013 Feb;44(2):407-13. doi: 10.1161/STROKEAHA.112.662148. Epub 2013 Jan 3. PubMed 23287785 ↗
  • Kamel H, Navi BB, Elijovich L, Josephson SA, Yee AH, Fung G, Johnston SC, Smith WS. Pilot randomized trial of outpatient cardiac monitoring after cryptogenic stroke. Stroke. 2013 Feb;44(2):528-30. doi: 10.1161/STROKEAHA.112.679100. Epub 2012 Nov 27. PubMed 23192756 ↗
  • Hotter B, Pittl S, Ebinger M, Oepen G, Jegzentis K, Kudo K, Rozanski M, Schmidt WU, Brunecker P, Xu C, Martus P, Endres M, Jungehulsing GJ, Villringer A, Fiebach JB. Prospective study on the mismatch concept in acute stroke patients within the first 24 h after symptom onset - 1000Plus study. BMC Neurol. 2009 Dec 8;9:60. doi: 10.1186/1471-2377-9-60. PubMed 19995432 ↗
09

Timeline

Tracking since Sep 25, 2026
Not marked actual or estimatedDates not marked actual or estimated

The record gives a start of Jul 2008, a primary completion of Jul 2013 and a completion of Jul 2013. It does not say whether these dates are actual or estimated.

How these figures are worked out, and which studies are left out of them.

Registered
Jul 11, 2008
First posted
Jul 15, 2008
Start
Jul 2008
Primary completionActual
Jul 2013
CompletionActual
Jul 2013
Last update
Jun 24, 2014
What these dates mean
Start.
When the first participant enrolled; while estimated, when the study expects to open to recruitment.
Primary completion.
When the last participant was examined or treated to collect data for the study's main question, its primary outcome. A study that stopped early gives the date its data collection stopped.
Completion.
When the last participant's last visit took place, for every outcome, secondary ones and side effects included: the end of the study. Often later than primary completion, sometimes the same day.
Actual and Est.
Actual means the registry says the date has happened. Est. (estimated) is a date the sponsor plans or expects. It can still move, and the sponsor is expected to change it to actual once it has passed.
No changes since tracking began. The registry record was last updated on Jun 24, 2014, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗
10

Registry details

Key details

Study ID
NCT00715533
Lead sponsor
Charite University, Berlin, Germany
Collaborators
German Federal Ministry of Education and Research
Responsible party
Jochen B. Fiebach (MD, Charite University, Berlin, Germany) — Principal investigator
First posted
Jul 15, 2008
Start date
Jul 2008
Primary completion
Jul 2013
Completion
Jul 2013
Last update
Jun 24, 2014

Study contacts

Jochen B. Fiebach, MD
principal investigator · Center for Stroke Research Berlin, Charité, Universitätsmedizin Berlin, Neurology

Oversight

Data monitoring committee
No
View the source record on ClinicalTrials.gov ↗

Not currently enrolling

This study is completed, as verified in Jun 2014. You cannot join it, but the record below documents what was studied.

Follow this study

Get an email when the registry record changes — status, dates, results — or when someone posts here.

Sign in to follow

Discussion

Questions and observations about this study, from anyone following it. Not medical advice, and not a channel to the study team — their contact details are on the registry record.

Sign in to join the discussion. Reading takes no account; posting does. You choose a display name, and a pseudonym is the default.

Nothing here yet. If you are running this trial, taking part in it, or weighing whether to, this is the place to say so.

Other studies in this condition

Stroke →

Other studies from this sponsor

Charite University, Berlin, Germany →

Start the discussion