Clinical trial NCT03157934: Schlaganfallkonsortium Rhein-Neckar (Stroke Consortium Rhine-Neckar)
Official title: Schlaganfallkonsortium Rhein-Neckar (Stroke Consortium Rhine-Neckar)
Study type: OBSERVATIONAL
Overall status: RECRUITING
Conditions: Ischemic Stroke
Vascular Diseases
Cardiovascular Diseases
Keywords: stroke network
acute stroke care
emergency medical services
integrated care
Lead sponsor: University Hospital Heidelberg
Sponsor class: OTHER
Collaborators: name: Dietmar Hopp Stiftung
First posted: 2017-05-17
Enrollment: 12000
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: OTHER
Time perspective: PROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: Acute stroke patients admitted to one of the hospitals of the Stroke Consortium Rhein-Neckar (FAST)

Brief summary: 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.

Detailed description: 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. The investigators 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. The investigators 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.

Eligibility criteria: 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

Primary outcomes:
measure: Functional outcome
timeFrame: 3 months after intervention
Secondary outcomes:
measure: Number of patients receiving acute recanalisation therapies of all referrals
timeFrame: 24 h after stroke onset
measure: Referral rates
timeFrame: Stroke onset to discharge from acute hospital; through study completion, an average of 2 years
Other outcomes:
Locations:
city: Heidelberg
country: Germany
facility: Heidelberg University Hospital
Study officials:
affiliation: University Hospital Heidelberg
name: Wolfgang Wick, Prof. Dr.
role: PRINCIPAL_INVESTIGATOR
References: