German Stroke Registry
a collaboration for multicenter studies on stroke therapy in Germany
Aim: to facilitate multicenter registry studies on stroke therapy in Germany
Primary aim: to establish a registry to assess practices, safety, and effectiveness of endovascular treatment in routine care of acute ischemic stroke
Key features of the GSR: multidisciplinary, bottom up, simple, practical, large numbers
Steering Committee (SC): everybody who contributes a relevant number of complete datasets; this number will gradually grow up to N=50 as recruitment goes on
SC chair: The Steering chair is elected by the SC for a term of 1 year. The task of the SC chair is to organize and moderate telephone conferences, write minutes, revise minutes, and help organizing meetings
Database and data access: web based; the complete database is mirrored at at least one additional site; all members of the SC have full access to the complete dataset; the database operates with pseudonyms
Data collection: data will be collected as part of clinical routine
Funding: none
Data ownership: each participating center remains the owner of its data. Upon request data will be retracted from the database at any time. Also, there is an opt out possibility for individual projects
Proposals for projects (analyses): can be entertained by every member of the SC using the “GSR proposal form”. Project proposals will be discussed and approved at regular telephone conferences
Publication policy: inclusive (multi-author): those doing the work will receive the credit
1. Project
1.1 Synopsis
Title
German registry study to assess practices, safety, and effectiveness of endovascular treatment in routine care of acute ischemic stroke
Devices for Endovascular Treatment
To be discussed (suggestion: all commonly used devices - no restrictions. However, the primary focus will be on the following devices: Solitaire, TREVO, ReVive SE)
Coordinating investigators
For the beginning these might be those setting the registry up. However, responsibilities should rotate as the study moves on (steering committee with rotating chairs)
Number of sites
Not limited; selection criteria to be defined by Steering committee
Indication
Acute ischemic stroke
Study design
Non-interventional, open-label, prospective, multicentre, observational registry study
Comment: can later be turned into a controlled (e.g. cluster randomized registry study as recruitment goes on)
Study groups
All patients receive acute stroke care according to local treatment standards, not amended or influenced by the study:
endovascular group: Patients who are treated with endovascular therapy; details follow local clinical practice
Comment: participating centers may agree on harmonizing protocols. However, this decision will be taken independent from the registry.
Study timelines
Patient recruitment Q3/2015 onwards
End of Study: not predefined
Study duration
Patients are followed over 90 days
Sample size
Aim for ≥1000 patients
Study objectives
Investigation of clinical practices, safety and effectiveness of endovascular treatment in routine care of patients with acute ischemic stroke
Documented parameters (Patient’s data will be entered through a web-based interface)
Baseline:
- Patient data (age, month and year of birth, gender)
- Patient logistics (symptom onset, admission weekday)
- Vascular risk factors
- Medication
- mRS before admission
- NIHSS
- Imaging findings (CT, CT-Angiography, MRI, MR-Angiography
Treatment:
- i.v. Thrombolysis with rtPA (timing, dose)
- Endovascular treatment (timing, type of anesthesia, device used, adverse events)
24h:
- NIHSS
- Imaging findings (CT/MRI)
- Adverse events
Discharge:
- Patient logistics (length of stay, transfer destination)
- Imaging findings
- NIHSS, mRS
- Stroke etiology (TOAST classification)
- Adverse events
Day 90±10:
- mRS
- EQ-5D
- Adverse events
- Cognitive status (MoCA)
Inclusion criteria
- Clinical diagnosis of acute ischemic stroke
- Confirmed diagnosis of persistent occlusion of terminal carotid artery, middle cerebral artery (M1 or M2), or basilar artery consistent with symptoms
- Endovascular treatment (EVT) attempted (i.e. groin puncture initiated, including all cases where EVT failed or was interrupted)
- Age ≥18 years
- Ethic approval in process
Exclusion criteria
- none
1.2 Treatment
Acute stroke patients admitted to hospital are stabilized and receive regular care. The treatment of patients will not be influenced in any way by the study. Patients complying with the inclusion criteria are eligible for study participation.