Schlaganfallkonsortium Rhein-Neckar (Stroke Consortium Rhine-Neckar)

Cardiovascular Diseases Clinical Trial

— FAST  

Official title:

Schlaganfallkonsortium Rhein-Neckar (Stroke Consortium Rhine-Neckar)

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT03157934
• Other study ID #: FAST
• Status: Recruiting
• Start date: October 26, 2017
• Est. completion date: March 2024

Study information

• Verified date: November 2023
• Source: University Hospital Heidelberg
• Contact: Loraine Busetto, Dr.
• Phone: +49622156
• Email: loraine.busetto[@]med.uni-heidelberg.de
• Is FDA regulated: No
• Study type: Observational [Patient Registry]

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 12000
• Est. completion date: March 2024
• Est. primary completion date: December 2023
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

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

Related Conditions & MeSH terms

• Cardiovascular Diseases
• Ischemic Stroke
• Stroke
• Vascular Diseases

Intervention

Other:
• not applicable (observational study)
Observational study without study related intervention

Locations

Country	Name	City	State
Germany	Heidelberg University Hospital	Heidelberg

Sponsors (2)

Lead Sponsor	Collaborator
University Hospital Heidelberg	Dietmar Hopp Stiftung

Country where clinical trial is conducted

Germany, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Functional outcome	Functional outcome according to the modified Rankin Scale (mRS)	3 months after intervention
Secondary	Number of patients receiving acute recanalisation therapies of all referrals	Number of patients receiving thrombolysis and/or thrombectomy of all patients included in to the Network via the database.	24 h after stroke onset
Secondary	Referral rates	Referral rates by stroke service level (i.e. type of treatment center)	Stroke onset to discharge from acute hospital; through study completion, an average of 2 years

External Links

•   FAST on Twitter
•   FAST Website with download Resources