Schlaganfallkonsortium Rhein-Neckar (Stroke Consortium Rhine-Neckar) (FAST)

November 28, 2023 updated by: Prof. Dr. Wolfgang Wick, University Hospital Heidelberg
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.

Study Overview

Status

Recruiting

Conditions

Intervention / Treatment

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 Type

Observational

Enrollment (Estimated)

12000

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

Study Contact Backup

Study Locations

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years and older (Adult, Older Adult)

Accepts Healthy Volunteers

No

Sampling Method

Non-Probability Sample

Study Population

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

Description

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 Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

Cohorts and Interventions

Group / Cohort
Intervention / Treatment
Primary CSC (Comprehensive Stroke center) 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 (non-Comprehensive Stroke Center) SU (Stroke Unit) 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

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Functional outcome
Time Frame: 3 months after intervention
Functional outcome according to the modified Rankin Scale (mRS)
3 months after intervention

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Number of patients receiving acute recanalisation therapies of all referrals
Time Frame: 24 h after stroke onset
Number of patients receiving thrombolysis and/or thrombectomy of all patients included in to the Network via the database.
24 h after stroke onset
Referral rates
Time Frame: 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)
Stroke onset to discharge from acute hospital; through study completion, an average of 2 years

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

University Hospital Heidelberg

Collaborators

Dietmar Hopp Stiftung

Investigators

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

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

Helpful Links

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

October 26, 2017

Primary Completion (Estimated)

December 1, 2023

Study Completion (Estimated)

March 1, 2024

Study Registration Dates

First Submitted

May 16, 2017

First Submitted That Met QC Criteria

May 16, 2017

First Posted (Actual)

May 17, 2017

Study Record Updates

Last Update Posted (Actual)

November 29, 2023

Last Update Submitted That Met QC Criteria

November 28, 2023

Last Verified

November 1, 2023

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • FAST

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

UNDECIDED

IPD Plan Description

Subject to approval by ethics committee

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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