Trial record 1 of 5 for: GSR | stroke

Previous Study | Return to List | Next Study

German Stroke Registry - Endovascular Treatment (GSR-ET)

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Know the risks and potential benefits of clinical studies and talk to your health care provider before participating. Read our disclaimer for details.

ClinicalTrials.gov Identifier: NCT03356392

Recruitment Status : Recruiting

First Posted : November 29, 2017

Last Update Posted : January 30, 2018

See Contacts and Locations

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

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

Layout table for study information

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

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

Primary Outcome Measures :

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

Information from the National Library of Medicine

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.

Layout table for eligibility information

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

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

Layout table for location contacts

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

Layout table for location information

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