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.