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German Stroke Registry - Endovascular Treatment (GSR-ET)

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ClinicalTrials.gov Identifier: NCT03356392
Recruitment Status : Recruiting
First Posted : November 29, 2017
Last Update Posted : January 30, 2018
Sponsor:
Collaborators:
Charite University, Berlin, Germany
University of Göttingen
University Hospital, Bonn
University Hospital, Frankfurt
Wuerzburg University Hospital
RWTH Aachen University
Technische Universität München
Asklepios Klinik Altona
Klinikum Osnabrück
Asklepios Klinik Wandsbek
Sana Klinikum Offenbach
Klinikum Dortmund
Krankenhaus Buchholz
Klinikum Lüneburg
KRH Klinikum Nordstadt
Kliniken Köln
Bezirkskliniken Schwaben Bezirkskrankenhaus Günzburg
Klinikum Altenburger Land
University Hospital Tuebingen
Klinikum Stadt Hanau
Universitätsklinikum Köln
Klinikum Bremen-Mitte, gGmbH
Uniklinikum Giessen und Marburg
University Hospital Muenster
Klinikum der Universitaet Muenchen
Information provided by (Responsible Party):
Universitätsklinikum Hamburg-Eppendorf

Study Description
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Brief Summary:
The German Stroke Registry (GSR) Endovascular Treatment is an academic, independent, prospective, multicentre, observational registry study. Consecutive patients treated with endovascular stroke treatment will be enrolled in German stroke centers. Patients receive regular care and data will be collected as part of clinical routine. Baseline clinical and procedural information as well clinical follow-up information during in-hospital stay, and up to 90 days of stroke onset are collected. Data collected include demographics, National Institute of Health Stroke Scale (NIHSS) on admission, pre-treatment ASPECTS, information on timing and success of interventional treatment, procedural complications, intracranial hemorrhage, and functional outcome.

Condition or disease Intervention/treatment
Acute Ischemic Stroke Other: telephone call d90

Study Design
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Study Type : Observational [Patient Registry]
Estimated Enrollment : 2500 participants
Observational Model: Cohort
Time Perspective: Prospective
Target Follow-Up Duration: 90 Days
Official Title: German Stroke Registry - Endovascular Treatment
Actual Study Start Date : June 2015
Estimated Primary Completion Date : June 2020
Estimated Study Completion Date : June 2025
Groups and Cohorts
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Group/Cohort Intervention/treatment
stroke patients
acute stroke patients treated with endovascular treatment combined with thrombolysis or without previous thrombolysis Intervention: telephone call on day 90 to assess the primary outcome (mRs d90)
 Other: telephone call d90
telephone call on day 90 to assess the primary outcome (mRs d90)


Outcome Measures
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Primary Outcome Measures :
  1. modified ranking scale on day (mRs) day 90 [ Time Frame: 90 days ]
    mRs: modified ranking scale; the scale is a commonly used measurement for the degree of disability or dependence in the daily activities of people who have suffered a stroke; scale range 0-6, with 0 - No symptoms. 1 - No significant disability. Able to carry out all usual activities, despite some symptoms. 2 - Slight disability. Able to look after own affairs without assistance, but unable to carry out all previous activities. 3 - Moderate disability. Requires some help, but able to walk unassisted. 4 - Moderately severe disability. Unable to attend to own bodily needs without assistance, and unable to walk unassisted. 5 - Severe disability. Requires constant nursing care and attention, bedridden, incontinent. 6 - Dead. publication: van Swieten J, Koudstaal P, Visser M, Schouten H, et al. (1988). "Interobserver agreement for the assessment of handicap in stroke patients". Stroke. 19 (5): 604-607. doi:10.1161/01.str.19.5.604. PMID 3363593.


Eligibility Criteria
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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Sampling Method:   Probability Sample
Study Population
all acute stroke patients with the clinical diagnosis of acute ischemic stroke, eligible for IVT and IVT initiated within 4.5 hours after stroke onset, Age >18 years
Criteria

Inclusion Criteria:

  • Clinical diagnosis of acute ischemic stroke
  • Eligible for intravenous thrombolysis (IVT) and IVT initiated within 4.5 hours after stroke onset
  • Confirmed diagnosis of persistent occlusion of terminal carotid artery, middle cerebral artery (M1 or M2), or basilar artery consistent with symptoms
  • Age >18 years
  • Ethic approval in process

Exclusion Criteria:

none

Contacts and Locations
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Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03356392


Contacts
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Contact: Anna Christina Alegiani, Dr 0049-15222816679 a.alegiani@uke.de
Contact: Frank Wollenweber, PD Dr. +49 (0)89 4400 - 46046 frank.wollenweber@med.uni-muenchen.de

Locations
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Germany
University Medical Center Hamburg-Eppendorf (UKE) Recruiting
Hamburg, Germany, 20251
Contact: Anna Alegiani       a.alegiani@uke.de   
Contact: Götz Thomalla       thomalla@uke.de   
Principal Investigator: Christian Gerloff         
Sponsors and Collaborators
Universitätsklinikum Hamburg-Eppendorf
Charite University, Berlin, Germany
University of Göttingen
University Hospital, Bonn
University Hospital, Frankfurt
Wuerzburg University Hospital
RWTH Aachen University
Technische Universität München
Asklepios Klinik Altona
Klinikum Osnabrück
Asklepios Klinik Wandsbek
Sana Klinikum Offenbach
Klinikum Dortmund
Krankenhaus Buchholz
Klinikum Lüneburg
KRH Klinikum Nordstadt
Kliniken Köln
Bezirkskliniken Schwaben Bezirkskrankenhaus Günzburg
Klinikum Altenburger Land
University Hospital Tuebingen
Klinikum Stadt Hanau
Universitätsklinikum Köln
Klinikum Bremen-Mitte, gGmbH
Uniklinikum Giessen und Marburg
University Hospital Muenster
Klinikum der Universitaet Muenchen
Investigators
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Principal Investigator: Martin Dichgans, Prof LMU, Munich, Germany
Principal Investigator: Christian Gerloff, Prof UKE, Hamburg, Germany
More Information
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Additional Information:

Publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):
Alegiani AC, Dorn F, Herzberg M, Wollenweber FA, Kellert L, Siebert E, Nolte CH, von Rennenberg R, Hattingen E, Petzold GC, Bode FJ, Pfeilschifter W, Schäfer JH, Wagner M, Röther J, Eckert B, Kraft P, Pham M, Boeckh-Behrens T, Wunderlich S, Bernkopf K, Reich A, Wiesmann M, Mpotsaris A, Psychogios M, Liman J, Maier I, Berrouschot J, Bormann A, Limmroth V, Spreer J, Petersen M, Krause L, Lowens S, Kraemer C, Zweynert S, Lange KS, Thonke S, Kastrup A, Papanagiotou P, Alber B, Braun M, Fiehler J, Gerloff C, Dichgans M, Thomalla G. Systematic evaluation of stroke thrombectomy in clinical practice: The German Stroke Registry Endovascular Treatment. Int J Stroke. 2019 Jun;14(4):372-380. doi: 10.1177/1747493018806199. Epub 2018 Oct 22. Erratum in: Int J Stroke. 2018 Dec 17;:1747493018816194. Eur J Prev Cardiol. 2020 Nov;27(17):NP16.

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Responsible Party: Universitätsklinikum Hamburg-Eppendorf
ClinicalTrials.gov Identifier: NCT03356392    
Other Study ID Numbers: GSR-ET
First Posted: November 29, 2017    Key Record Dates
Last Update Posted: January 30, 2018
Last Verified: January 2018

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
Keywords provided by Universitätsklinikum Hamburg-Eppendorf:
acute stroke, thrombectomy, endovascular treatment
Additional relevant MeSH terms:
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Stroke
Cerebrovascular Disorders
Brain Diseases
Central Nervous System Diseases
 Nervous System Diseases
Vascular Diseases
Cardiovascular Diseases