Schlaganfallkonsortium Rhein-Neckar (Stroke Consortium Rhine-Neckar)

Recruiting

• Conditions: Vascular Diseases; Cardiovascular Diseases; Ischemic Stroke
• Interventions: Other: not applicable (observational study)

• Registration Number: NCT03157934
• Lead Sponsor: University Hospital Heidelberg

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.

Study Timeline

• Study First Submitted: 2017-05-16
• Study First Submitted QC: 2017-05-16
• Study First Posted: 2017-05-17
• Study Start: 2017-10-26
• Status Verified: 2023-11
• Last Update Submitted: 2023-11-28
• Last Update Posted: 2023-11-29
• Primary Completion: 2023-12
• Study Completion: 2024-03

Recruitment & Eligibility

• Status: RECRUITING
• Sex: All
• Target Recruitment: 12000

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

Study & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Arm && Interventions

Group	Intervention	Description
Non-acute stroke hospital admission	not applicable (observational study)	Patients with primary admission to non-acute stroke-ready hospital
Primary non-CSC (non-Comprehensive Stroke Center) SU (Stroke Unit) admission	not applicable (observational study)	Patients with primary admission to non-endovascular-ready hospital with (regional/local) stroke unit
Primary CSC (Comprehensive Stroke center) admission	not applicable (observational study)	Patients with primary admission to endovascular-ready hospital (comprehensive stroke center)

Primary Outcome Measures

Name	Time	Method
Functional outcome	3 months after intervention	Functional outcome according to the modified Rankin Scale (mRS)

Secondary Outcome Measures

Name	Time	Method
Referral rates	Stroke onset to discharge from acute hospital; through study completion, an average of 2 years	Referral rates by stroke service level (i.e. type of treatment center)
Number of patients receiving acute recanalisation therapies of all referrals	24 h after stroke onset	Number of patients receiving thrombolysis and/or thrombectomy of all patients included in to the Network via the database.

Trial Locations

Locations (1)

Heidelberg University Hospital; 🇩🇪 Heidelberg, Germany