Schlaganfallkonsortium Rhein-Neckar (Stroke Consortium Rhine-Neckar)


Original post, click here

Verified May 2017 by University Hospital Heidelberg

Sponsor:

Collaborator:

Dietmar Hopp Stiftung

Information provided by (Responsible Party):

Prof. Dr. Wolfgang Wick, University Hospital Heidelberg

ClinicalTrials.gov Identifier:

NCT03157934

First received: May 16, 2017

Last updated: May 16, 2017

Last verified: May 2017

FAST is an investigator-initiated multicenter study embedded in a German multistate acute stroke network. The main objectives of the FAST study are to improve outcomes and quality of care for stroke patients, to quantify the number of patients in need of thrombectomy within an integrated stroke network, to study the best way of delivering and performing thrombectomy and to investigate the best model of pre-hospital selection and referral for stroke patients.

Ischemic Stroke
Vascular Diseases
Cardiovascular Diseases
Other: not applicable (observational study)

Study Type: Observational [Patient Registry]
Study Design: Observational Model: Other
Time Perspective: Prospective
Target Follow-Up Duration: 3 Months
Official Title: Schlaganfallkonsortium Rhein-Neckar (Stroke Consortium Rhine-Neckar)

Primary Outcome Measures:

Estimated Enrollment: 12000
Anticipated Study Start Date: June 2017
Estimated Study Completion Date: March 2019
Estimated Primary Completion Date: December 2018 (Final data collection date for primary outcome measure)
Primary CSC admission

Patients with primary admission to endovascular-ready hospital (comprehensive stroke center)

Other: not applicable (observational study)

Observational study without study related intervention

Primary non-CSC SU admission

Patients with primary admission to non-endovascular-ready hospital with (regional/local) stroke unit

Other: not applicable (observational study)

Observational study without study related intervention

Non-acute stroke hospital admission

Patients with primary admission to non-acute stroke-ready hospital

Other: not applicable (observational study)

Observational study without study related intervention

Since 2015, mechanical thrombectomy in patients with large vessel occlusion has become an evidence based highly efficient treatment. In contrast to thrombolysis, thrombectomy can only be delivered by qualified interventionalists at comprehensive stroke centers. Thus, the implementation of thrombectomy into clinical practice remains a challenge. We aim to establish a population based approach within a patient registry in a federal state overarching regional stroke network covering over 4 million inhabitants and integrating approximately 30 hospitals with different levels of expertise. The registry will include data from all acute ischemic stroke patients – approx. 12.000 patients p.a – within the network. We plan to establish a central multi-interface platform integrating clinical data from the prehospital, intrahospital and rehabilitation phase including mandatory quality assurance, neurological and neuroradiological treatment and outcome data. The registry will allow addressing important questions, such as how many patients are candidates for thrombectomy, how many resources are needed to meet that demand and how treatment procedures and times can be improved. The overarching aim is to deliver high quality stroke care to every patient in the region.

Ages Eligible for Study:   18 Years and older   (Adult, Senior)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Sampling Method:   Non-Probability Sample

Acute stroke patients admitted to one of the hospitals of the Stroke Consortium Rhein-Neckar (FAST)

Inclusion Criteria:

  • 18 years or older
  • Patients with ischemic stroke who are admitted to one of the hospitals of the Stroke Consortium Rhein-Neckar (FAST)
  • informed consent

Exclusion Criteria:

  • no informed consent

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, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT03157934

University Hospital Heidelberg

Dietmar Hopp Stiftung

Principal Investigator: Wolfgang Wick, Prof. Dr. University Hospital Heidelberg

Additional Information:

Responsible Party: Prof. Dr. Wolfgang Wick, University Hospital Heidelberg
ClinicalTrials.gov Identifier: NCT03157934     History of Changes
Other Study ID Numbers: FAST
Study First Received: May 16, 2017
Last Updated: May 16, 2017
Individual Participant Data  
Plan to Share IPD: Undecided
Plan Description: Subject to approval by ethics committee

Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No

Keywords provided by University Hospital Heidelberg:

stroke network
acute stroke care
emergency medical services
integrated care

Additional relevant MeSH terms:

Stroke
Cardiovascular Diseases
Vascular Diseases
Cerebrovascular Disorders
Brain Diseases
Central Nervous System Diseases
Nervous System Diseases

ClinicalTrials.gov processed this record on May 17, 2017