Ischemic StrokeFASTNCT03157934
Schlaganfallkonsortium Rhein-Neckar (Stroke Consortium Rhine-Neckar)
An observational study of Ischemic Stroke and Vascular Diseases, run by University Hospital Heidelberg at 1 site in Germany.
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… Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Ischemic Stroke, Vascular Diseases, Cardiovascular Diseases
- What is being tested?
- not applicable (observational study)
- How many people
- 12,000 participants
- Where
- 1 siteGermany
- Study dates
- 26 Oct 2017to Mar 2024
- How long will I take part?
- 3 Months
- Phase
- Observational
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Study population: Acute stroke patients admitted to one of the hospitals of the Stroke Consortium Rhein-Neckar (FAST)
Who may be able to join
- 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
Who cannot join
- no informed consent
Trial locations and contacts
1 site in 1 country.
Germany1 site, 1 recruiting
- Recruiting
Heidelberg University Hospital
Heidelberg, 69120
Loraine Busetto, Dr., +49622156 ext. 34149, loraine.busetto@med.uni-heidelberg.de
About this study
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.
Read the 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.
- Conditions
- Ischemic Stroke, Vascular Diseases, Cardiovascular Diseases
- Being tested
- not applicable (observational study)
- Keywords
- stroke network, acute stroke care, emergency medical services, integrated care
- Medical subject headings
- Ischemic Stroke, Vascular Diseases, Cardiovascular Diseases
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
not applicable (observational study)Other
Observational study without study related intervention
| Study group | Role | What they receive |
|---|---|---|
| Primary CSC (Comprehensive Stroke center) admission | Patients with primary admission to endovascular-ready hospital (comprehensive stroke center) Receives: Other: not applicable (observational study) | |
| 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 Receives: Other: not applicable (observational study) | |
| Non-acute stroke hospital admission | Patients with primary admission to non-acute stroke-ready hospital Receives: Other: not applicable (observational study) |
What is being measured
The primary outcome is the main question the study is designed to answer.
Functional outcome
Functional outcome according to the modified Rankin Scale (mRS)
Measured: 3 months after intervention
Secondary outcomes (2)
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.
Measured: 24 h after stroke onset
Referral rates
Referral rates by stroke service level (i.e. type of treatment center)
Measured: Stroke onset to discharge from acute hospital; through study completion, an average of 2 years
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted17 May 2017
- Study start26 Oct 2017
- Primary completionDec 2023 (estimated)
- Study completionMar 2024 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Ischemic StrokeStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Other
- Time perspective
- Prospective
- Enrolment
- 12,000 participants (estimated)
- Target duration
- 3 Months
Sponsor and investigators
- Lead sponsor
- University Hospital Heidelberg
- Sponsor type
- University, hospital or other
- Collaborators
- Dietmar Hopp Stiftung
- Responsible party
- Principal investigator, Prof. Dr. Wolfgang Wick, University Hospital Heidelberg
- Investigators
- Wolfgang Wick, Prof. Dr., Principal investigator, University Hospital Heidelberg
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03157934
- Sponsor's protocol ID
- FAST
- Acronym
- FAST
- Status last verified
- Nov 2023
- First submitted
- 16 May 2017
- Last updated
- 29 Nov 2023
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Undecided: Subject to approval by ethics committee
Study at a glance
From the registry record, last updated by the sponsor on 29 Nov 2023. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Schlaganfallkonsortium Rhein-Neckar (Stroke Consortium Rhine-Neckar)
- ClinicalTrials.gov ID
- NCT03157934
- Acronym / sponsor ID
- FAST / FAST
- Conditions
- Ischemic Stroke, Vascular Diseases, Cardiovascular Diseases
- Keywords
- stroke network, acute stroke care, emergency medical services, integrated care
- Study type
- Observational
- Recruitment status
- Unknown status
- Enrolment
- 12,000 participants (estimated)
- Lead sponsor
- University Hospital HeidelbergUniversity, hospital or other
- Collaborators
- Dietmar Hopp Stiftung
- Study start
- 26 Oct 2017 (actual)
- Primary completion
- Dec 2023 (estimated)
- Study completion
- Mar 2024 (estimated)
- First posted
- 17 May 2017 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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 design
- Observational model
- Other
- Time perspective
- Prospective
- Target follow-up
- 3 Months
- Number of arms
- 3
| Arm | Type | Receives |
|---|---|---|
| Primary CSC (Comprehensive Stroke center) admission | – | Other: not applicable (observational study)Patients with primary admission to endovascular-ready hospital (comprehensive stroke center) |
| Primary non-CSC (non-Comprehensive Stroke Center) SU (Stroke Unit) admission | – | Other: not applicable (observational study)Patients with primary admission to non-endovascular-ready hospital with (regional/local) stroke unit |
| Non-acute stroke hospital admission | – | Other: not applicable (observational study)Patients with primary admission to non-acute stroke-ready hospital |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- Acute stroke patients admitted to one of the hospitals of the Stroke Consortium Rhein-Neckar (FAST)
Key inclusion criteria (3 listed)
- 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
Key exclusion criteria (1 listed)
- no informed consent
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| not applicable (observational study)Observational study without study related intervention | Other | Non-acute stroke hospital admission, Primary CSC (Comprehensive Stroke center) admission, Primary non-CSC (non-Comprehensive Stroke Center) SU (Stroke Unit) admission |
Primary outcome
Functional outcome
Time frame: 3 months after intervention
Functional outcome according to the modified Rankin Scale (mRS)
2 secondary outcomes
Number of patients receiving acute recanalisation therapies of all referrals
Time frame: 24 h after stroke onset
Referral rates
Time frame: Stroke onset to discharge from acute hospital; through study completion, an average of 2 years
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 29 Nov 2023.
- FAST on TwitterLink provided by the sponsor.
- FAST Website with download ResourcesLink provided by the sponsor.
- Individual participant dataSharing planned: Undecided. Subject to approval by ethics committee
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Wolfgang Wick, Prof. Dr. principal investigator
University Hospital Heidelberg
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Ischemic Stroke and Vascular Diseases, run by University Hospital Heidelberg at 1 site in Germany.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 3 inclusion and 1 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: status not confirmed, as of the sponsor's last update on 29 Nov 2023. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Germany. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Loraine Busetto, Dr. (+49622156 ext. 34149, loraine.busetto@med.uni-heidelberg.de), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Functional outcome (time frame: 3 months after intervention). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 29 Nov 2023.