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Acute Stroke1000PlusNCT00715533

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

An observational study of Acute Stroke and Transient Ischemic Attack, run by Charite University, Berlin, Germany at 1 site in Germany.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record
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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. Read more about this study

Who is it for?
Ages 18 years and older
Conditions the study is for
Acute Stroke, Transient Ischemic Attack
How many people
1,500 participants
Where
1 siteGermany
Study dates
Jul 2008to Jul 2013
Phase
Observational
Are there results?
None posted in the registry

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

  • Ages 18 years and older
  • All sexes
  • No healthy volunteers
  • Adult, Older adult

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

Who may be able to join

  • Suspected stroke or TIA within 24 hours from symptom onset

Who cannot join

  • MRI contraindication

Trial locations and contacts

1 site in 1 country.

Germany1 site

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

    Berlin, 12200

Other trials in Germany

About this study

Official title: 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.

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
Keywords
acute (< 24 hours) stroke, stroke, TIA, MRI, imaging, acute
Medical subject headings
Stroke, Ischemic Attack, Transient

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. change of infarct size between baseline and day 6

    Measured: day 6

Secondary outcomes (1)

  1. clinical score (modified Rankin Scale)

    Measured: day 90

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted15 Jul 2008 (estimated)
  2. Study startJul 2008
  3. Primary completionJul 2013
  4. Study completionJul 2013

Resources

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design
Study type
Observational
Observational model
Cohort
Time perspective
Prospective
Enrolment
1,500 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT00715533
Sponsor's protocol ID
CCBF-1000+
Other IDs
4-026-08
Acronym
1000Plus
Status last verified
Jun 2014
First submitted
11 Jul 2008
Last updated
24 Jun 2014
Results posted
No
Data monitoring committee
No

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

Questions about this trial

What is this clinical trial studying?

An observational study of Acute Stroke and Transient Ischemic Attack, run by Charite University, Berlin, Germany at 1 site in Germany.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 1 inclusion and 1 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: finished, as of the sponsor's last update on 24 Jun 2014. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 1 site in Germany. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

Are results available for this study?

The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

change of infarct size between baseline and day 6 (time frame: day 6). It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT00715533, which also lists 15 linked publications.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 24 Jun 2014; AzTrials last refreshed its copy on 6 Nov 2026.

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