Stroke, Acute IschemicNCT05833945
Potential Use of a POCT for the Direct Transfer of Stroke Patients From the Ambulance to the Thrombectomy Center
An observational study of Stroke, Acute Ischemic, run by Fundación Pública Andaluza para la gestión de la Investigación en Sevilla at 16 sites in Spain.
Trial summary
Stroke is the leading cause of long-term disability and the second most common cause of death worldwide. Currently, the protocols require the imaging techniques at the hospitals to differ ischemic strokes with large vessel occlusion (LVO) from others. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Stroke, Acute Ischemic
- What is being tested?
- Large Vessel Occlusion Biomarkers Test
- Type of treatment
- Medical device
- How many people
- 355 participants
- Where
- 16 sitesSpain
- Study dates
- 15 Apr 2023to 24 Apr 2024
- 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: Patients with stroke code activated will be recruited at a pre-hospital and hospital environment.
Who may be able to join
- I.1: Patients > 18 years old.
- I.2: Stroke code activated.
- I.3: < 6 hours from symptoms onset. In the case of stroke with uncertain chronology or wake-up stroke, the initial time will be considered as the last moment the patient was seen fine.
Who cannot join
- E.1: Previous diagnosis different from stroke.
- E.2: Impossibility of getting a blood sample.
- E.3: Refusal to provide the informed consent by the patient/relative.
Trial locations and contacts
16 sites in 1 country.
16 sites in 1 country
Spain16 sites
Complejo Hospitalario Universitario Albacete
Albacete
Hospital Universitario Poniente
Almería
Hospital Universitario Torrecárdenas
Almería
Hospital General San Jorge
Huesca
Hospital San Pedro
Logroño
Hospital General Río Carrión
Palencia
Hospital General de Segovia
Segovia
Hospital Universitario Virgen Macarena
Seville
Hospital Universitario Virgen Rocío
Seville
Hospital La Fe
Valencia
Hospital Clínico de Valladolid
Valladolid
Hospital de Medina del Campo
Valladolid
Hospital Universitario Río Hortega
Valladolid
Hospital Clínico Universitario Lozano Blesa
Zaragoza
Hospital Miguel Servet
Zaragoza
Hospital Royo Villanova
Zaragoza
About this study
Official title: Study of the Potential Use of a Rapid Point-of-Care Device for the Direct Transfer of Stroke Patients From the Ambulance to the Thrombectomy Center
Stroke is the leading cause of long-term disability and the second most common cause of death worldwide. Currently, the protocols require the imaging techniques at the hospitals to differ ischemic strokes with large vessel occlusion (LVO) from others. In this study, a duplex POC will be used in combination with an APP to identify LVO ischemic strokes in a 800 patients'cohort with pre-hospital and in-hospital blood samples.
Read the detailed description
Stroke is the leading cause of long-term disability and the second most common cause of death worldwide, accounting for around 6.7 million deaths each year. The burden of stroke due to illness, disability and early death is set to double within the next 15 years due to an ageing population. Currently, imaging techniques are required to differentiate ischemic strokes with large vessel occlusion (LVO) from others. Since those neuroimages cannot be easily done at a pre-hospital level, our objective is to develop a simple point-of-care test (POC) to differentiate between both ischemic strokes during the acute phase, which will allow in the future an earlier thrombectomy treatment and an improvement of the patient outcomes significantly. For that, the investigators will recruit a 800 patients' cohort with pre-hospital and in-hospital blood samples by a multiplex POC for the biomarker measurement using an APP in combination with clinical data to identify LVO ischemic strokes. Finally, an interim analysis is planned when 400 patients are recruited.
- Conditions
- Stroke, Acute Ischemic
- Being tested
- Large Vessel Occlusion Biomarkers Test
- Keywords
- Large Vessels Occlusion (LVO), Thrombectomy, Biomarkers, Point of care test (POCT)
- Medical subject headings
- Ischemic Stroke
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Large Vessel Occlusion Biomarkers TestDevice
Duplex Point of Care test to measure the concentration of biomarkers associated to Large Vessel Occlusion in blood samples used in combination with an APP.
| Study group | Role | What they receive |
|---|---|---|
| Pre-hospital and in-hospital patients | Patients recruited at the ambulance (ARM A) and at the hospital (ARM B). Receives: Device: Large Vessel Occlusion Biomarkers Test |
What is being measured
The primary outcome is the main question the study is designed to answer.
Evaluation of the diagnosis accuracy of the algorithm LVOCheck (Specificity and sensibility)
- Biomarkers
- Clinical data (gender, age, diabetes, dyslipidemia, atrial fibrillation, blood pressure)
- Neurologic scales (NIHSS, RACE, GFAST, Cincinatti)
Measured: 6 months
Secondary outcomes (1)
Viability of the implement of the tool at a pre-hospital environment
- Estimated time in patients direct potentially transferred to the thrombectomy centers.
- Error rate in tool performance at a pre-hospital and hospital environment.
- Percentage of right use of the tool (human failares) at a pre-hospital and hospital environment.
Measured: 6 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted27 Apr 2023
- Study start15 Apr 2023
- Primary completion31 Jan 2024
- Study completion24 Apr 2024
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Stroke, Acute IschemicStudies 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
- Cohort
- Time perspective
- Prospective
- Enrolment
- 355 participants (actual)
Sponsor and investigators
- Lead sponsor
- Fundación Pública Andaluza para la gestión de la Investigación en Sevilla
- Sponsor type
- University, hospital or other
- Collaborators
- Hospital Universitario Virgen Macarena, Hospitales Universitarios Virgen del Rocío, Hospital Universitario Torrecárdenas, Hospital Universitario Poniente, Hospital Clínico Universitario Lozano Blesa, Hospital Miguel Servet, Hospital Universitario Royo Villanova, Hospital General San Jorge, Hospital San Pedro de Logroño, Hospital Clínico Universitario de Valladolid, Hospital Universitario La Fe, Complejo Hospitalario Universitario de Albacete, Hospital de Medina del Campo, Hospital General Río Carrión, Hospital General de Segovia, Hospital del Rio Hortega
- Responsible party
- Sponsor
- Investigators
- Ana Barragán Prieto, Principal investigator, Hospital Universitario Virgen Macarena
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05833945
- Sponsor's protocol ID
- BIOSHIP-training
- Status last verified
- Sep 2024
- First submitted
- 5 Apr 2023
- Last updated
- 18 Nov 2024
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Undecided: Individual participant data (IPD) might be included in a publication. Specific data set are not determined yet.
Study at a glance
From the registry record, last updated by the sponsor on 18 Nov 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Study of the Potential Use of a Rapid Point-of-Care Device for the Direct Transfer of Stroke Patients From the Ambulance to the Thrombectomy Center
- ClinicalTrials.gov ID
- NCT05833945
- Acronym / sponsor ID
- BIOSHIP-training
- Conditions
- Stroke, Acute Ischemic
- Keywords
- Large Vessels Occlusion (LVO), Thrombectomy, Biomarkers, Point of care test (POCT)
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 355 participants (actual)
- Lead sponsor
- Fundación Pública Andaluza para la gestión de la Investigación en SevillaUniversity, hospital or other
- Collaborators
- Hospital Universitario Virgen Macarena, Hospitales Universitarios Virgen del Rocío, Hospital Universitario Torrecárdenas, Hospital Universitario Poniente, Hospital Clínico Universitario Lozano Blesa, Hospital Miguel Servet, Hospital Universitario Royo Villanova, Hospital General San Jorge, Hospital San Pedro de Logroño, Hospital Clínico Universitario de Valladolid, Hospital Universitario La Fe, Complejo Hospitalario Universitario de Albacete, Hospital de Medina del Campo, Hospital General Río Carrión, Hospital General de Segovia, Hospital del Rio Hortega
- Study start
- 15 Apr 2023 (actual)
- Primary completion
- 31 Jan 2024 (actual)
- Study completion
- 24 Apr 2024 (actual)
- First posted
- 27 Apr 2023 (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.
Stroke is the leading cause of long-term disability and the second most common cause of death worldwide. Currently, the protocols require the imaging techniques at the hospitals to differ ischemic strokes with large vessel occlusion (LVO) from others. In this study, a duplex POC will be used in combination with an APP to identify LVO ischemic strokes in a 800 patients'cohort with pre-hospital and in-hospital blood samples.
Detailed description
Stroke is the leading cause of long-term disability and the second most common cause of death worldwide, accounting for around 6.7 million deaths each year. The burden of stroke due to illness, disability and early death is set to double within the next 15 years due to an ageing population. Currently, imaging techniques are required to differentiate ischemic strokes with large vessel occlusion (LVO) from others. Since those neuroimages cannot be easily done at a pre-hospital level, our objective is to develop a simple point-of-care test (POC) to differentiate between both ischemic strokes during the acute phase, which will allow in the future an earlier thrombectomy treatment and an improvement of the patient outcomes significantly. For that, the investigators will recruit a 800 patients' cohort with pre-hospital and in-hospital blood samples by a multiplex POC for the biomarker measurement using an APP in combination with clinical data to identify LVO ischemic strokes. Finally, an interim analysis is planned when 400 patients are recruited.
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Pre-hospital and in-hospital patients | – | Device: Large Vessel Occlusion Biomarkers TestPatients recruited at the ambulance (ARM A) and at the hospital (ARM B). |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- Patients with stroke code activated will be recruited at a pre-hospital and hospital environment.
Key inclusion criteria (3 listed)
- I.1: Patients > 18 years old.
- I.2: Stroke code activated.
- I.3: < 6 hours from symptoms onset. In the case of stroke with uncertain chronology or wake-up stroke, the initial time will be considered as the last moment the patient was seen fine.
Key exclusion criteria (3 listed)
- E.1: Previous diagnosis different from stroke.
- E.2: Impossibility of getting a blood sample.
- E.3: Refusal to provide the informed consent by the patient/relative.
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 |
|---|---|---|
| Large Vessel Occlusion Biomarkers TestDuplex Point of Care test to measure the concentration of biomarkers associated to Large Vessel Occlusion in blood samples used in combination with an APP. | Device | Pre-hospital and in-hospital patients |
Primary outcome
Evaluation of the diagnosis accuracy of the algorithm LVOCheck (Specificity and sensibility)
Time frame: 6 months
* Biomarkers * Clinical data (gender, age, diabetes, dyslipidemia, atrial fibrillation, blood pressure) * Neurologic scales (NIHSS, RACE, GFAST, Cincinatti)
1 secondary outcome
Viability of the implement of the tool at a pre-hospital environment
Time frame: 6 months
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 18 Nov 2024.
- Individual participant dataSharing planned: Undecided. Individual participant data (IPD) might be included in a publication. Specific data set are not determined yet.
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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.
Ana Barragán Prieto principal investigator
Hospital Universitario Virgen Macarena
16 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Stroke, Acute Ischemic, run by Fundación Pública Andaluza para la gestión de la Investigación en Sevilla at 16 sites in Spain.
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 3 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: finished, as of the sponsor's last update on 18 Nov 2024. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 16 sites in Spain. 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?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Evaluation of the diagnosis accuracy of the algorithm LVOCheck (Specificity and sensibility) (time frame: 6 months). 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 18 Nov 2024.