Stroke, IschemicTIMENCT04292600
Testing of Identification Markers for Stroke
An observational study of Stroke, Ischemic and Infarction, Middle Cerebral Artery, run by POCKiT diagnostics Ltd at 3 sites in United States.
Trial summary
Stroke is the third leading cause of death and the first cause of physical disability and dementia worldwide. Ischemic stroke caused by large vessel occlusion (LVO) is responsible for the vast majority of deaths and disabilities. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Stroke, Ischemic, Infarction, Middle Cerebral Artery, Infarction, Anterior Circulation, Brain
- What is being tested?
- POCKiT diagnostics' algorithm for LVO detection
- How many people
- 383 participants
- Where
- 3 sitesUnited States
- Study dates
- 1 May 2021to 31 Jan 2023
- 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 admitted to the ambulance and ED with suspected stroke will be recruited in the study. Patient population is expected to be composed of ~50% ischemic strokes (of which ~30-40% could have LVOs), ~40% stroke mimics, and ~10% haemorrhagic strokes.
Who may be able to join
- Referred to the ambulance or emergency department for suspected stroke.
- Time from stroke onset < 18 hours
Who cannot join
- Received thrombolytic therapy (e.g. tPA, Alteplase) before collection of blood;
- (Anticipated) inability to provide a blood sample;
- Time from stroke onset > 18 hours.
- At time of consent participating in a Clinical Trial Investigational Medicinal Product (CTIMP)
Trial locations and contacts
3 sites in 1 country.
United States3 sites
University of Alabama in Birmingham Comprehensive Stroke Center
Birmingham, Alabama, 35294
BAC Telemed - Brandon Regional Hospital
Brandon, Florida, 33511
University of Mississippi Medical Center
Jackson, Mississippi, 39216
About this study
Stroke is the third leading cause of death and the first cause of physical disability and dementia worldwide. Ischemic stroke caused by large vessel occlusion (LVO) is responsible for the vast majority of deaths and disabilities. A very effective and safe treatment, called mechanical thrombectomy (MT) is available for LVO patients. Nevertheless, no blood biomarkers able to identify LVO patients rapidly and to direct them to CT angiography and thrombectomy currently exist.
The TIME study is an observational prospective cohort study. All Patients referred to the emergency department or stroke unit with a suspected stroke as identified by paramedics, nurses or clinicians will be enrolled in the study. A panel of blood biomarkers will be analysed retrospectively via standard laboratory assays.
The main outcome of the TIME study will be the evaluation of the clinical diagnostic performance of a panel of blood biomarkers, in conjunction with clinical data, for the identification of large vessel occlusion ischemic stroke subtype. This study will allow the identification and evaluation of a final panel of biomarkers and will prompt the development of a test for LVO stroke diagnosis.
Read the detailed description
Stroke affects 16M people in the world every year and 100K in the UK only. More than 30% of these patients die and 90% of survivors develop permanent disabilities as a consequence of stroke. There are two main types of stroke, ischemic and haemorrhagic. Ischemic stroke is caused by the formation of a clot in a blood vessel in the brain and represents ~85% of stroke patients. Haemorrhagic stroke is due to the rupture of a blood vessel in the brain, with consequent bleeding, and it represents ~15% of stroke patients. Both stroke subtypes cause brain damage and their symptoms are very similar. In addition to these two types of stroke, among the population of suspected stroke patients, there are the so-called stroke "mimics". These are conditions that appear with stroke-like symptoms (e.g. migraine, epilepsy, encephalitis, etc) but that are not stroke.
The deadliest stroke subtype is the one caused by occlusion of large vessels (LVO) in the brain. For these patients, a new treatment is available, called thrombectomy, which is a surgical procedure that mechanically removes the clot via a probe inserted at the level of the groin. Treatment of LVO patients with mechanical thrombectomy (MT) significantly increases the chances of survival, as well as decreases the extent of disability1. MT is only available in comprehensive stroke centres (CSC), and LVO patients have to be transported specifically to CSC in order to be treated and increase their chances of survival. MT has been proven a safe and effective treatment for LVO stroke until 24 hours from stroke onset2, indicating that detection of LVO strokes several hours after onset can significantly aid the stroke care pathway.
Current treatment of stroke patients is dependent on diagnosis via computerised tomography (CT) scan to the head. CT is highly accurate for detection of brain haemorrhages, but is very inaccurate for detection of ischemic stroke or LVOs3. In case of a negative result from CT, neurologists can order a further MRI scan to confirm ischemic stroke. If LVO is suspected, patients are transported to the nearest CSC where a further procedure, called CT angiography, is performed. The identification of LVO patients can be a very lengthy process that wastes precious time and makes stroke patients worse.
Fast diagnosis of stroke patients at their first point of admission (i.e. ambulance or emergency department) able to identify LVO patients could quickly direct patients to CSC and significantly improve treatment of the most dangerous stroke subtype. Several studies have investigated the ability of pre-hospital assessment scores based on patient symptoms to be performed in the ambulance4-7. Despite this, these scoring scales lack the accuracy required for triaging LVO patients with confidence. A more accurate diagnostic test able to complement these assessment scores and direct LVO patients to CSC and CT angiography is much needed8.
POCKiT DX are developing a novel device for stroke diagnosis that combines accurate blood biomarkers with ultra-rapid (<20 minutes) biomarker detection within a point-of-care device. The panel of blood biomarkers identified by POCKiT DX was tested in 80 patients with suspected stroke and accuracy of 83% (CI 95%: 74-92%), sensitivity of 86% (CI 95%: 74-98%), and specificity of 82% (CI 95%: 68-95%) was observed for LVO identification.
The aim of the TIME study is to evaluate the clinical diagnostic performance of a panel of blood biomarkers identified by POCKiT diagnostics in the identification of LVO stroke patients among the population of suspected stroke. Diagnostic performance of blood biomarkers alone, and in conjunction with clinical data, including pre-hospital stroke assessment scores (e.g. EMSA), will be evaluated. Results of this study will direct the development of a diagnostic test for directing stroke patients to the right treatment, more rapidly, improving patient outcomes.
- Conditions
- Stroke, Ischemic, Infarction, Middle Cerebral Artery, Infarction, Anterior Circulation, Brain
- Being tested
- POCKiT diagnostics' algorithm for LVO detection
- Keywords
- large vessel occlusion strokes
- Medical subject headings
- Ischemic Stroke, Infarction, Middle Cerebral Artery, Brain Infarction
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
POCKiT diagnostics' algorithm for LVO detectionDiagnostic test
Measurement of blood biomarkers and integration within Pockit diagnostics' algorithm for LVO detection
| Study group | Role | What they receive |
|---|---|---|
| BRH | Cohort recruited at Brandon Regional Hospital by Bay Area Consulting Telemedicine Receives: Diagnostic Test: POCKiT diagnostics' algorithm for LVO detection |
What is being measured
The primary outcome is the main question the study is designed to answer.
Diagnostic accuracy measures for LVO detection vs non-LVO stroke activations
Accuracy of pre-defined algorithm thresholds for LVO identification from the population of all suspected strokes (Ischemics non-LVO, Hemorrhagic, Mimics, TIAs)
Measured: 1 year
Secondary outcomes (1)
Optimisation of the cut-off points of the diagnostic algorithm for LVO detection
Determine optimal cut-off points for diagnostic algorithm for detection of LVO vs non-LVO
Measured: 1 year
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted3 Mar 2020
- Study start1 May 2021
- Primary completion31 Aug 2022
- Study completion31 Jan 2023
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (5)Papers the sponsor has linked to this study.
- Other trials for Stroke, 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
- 383 participants (actual)
Sponsor and investigators
- Lead sponsor
- POCKiT diagnostics Ltd
- Sponsor type
- Industry (pharma, biotech, devices)
- Collaborators
- University of Alabama at Birmingham, University of Mississippi Medical Center, Bay Area Consulting Telemedicine
- Responsible party
- Sponsor
- Investigators
- Shashank Shekar, MD, Principal investigator, University of Mississippi Medical CenterToby Gropen, MD, Principal investigator, University of Alabama in Birmingham Comprehensive Stroke CenterAllauddin Khan, MD, Principal investigator, BAC Telemed (Brandon Regional Hospital)
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04292600
- Sponsor's protocol ID
- POCKiT
- Acronym
- TIME
- Status last verified
- Mar 2023
- First submitted
- 20 Feb 2020
- Last updated
- 3 Apr 2023
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Undecided
Publications
Malhotra K, Gornbein J, Saver JL. Ischemic Strokes Due to Large-Vessel Occlusions Contribute Disproportionately to Stroke-Related Dependence and Death: A Review. Front Neurol. 2017 Nov 30;8:651. doi: 10.3389/fneur.2017.00651. eCollection 2017.
PubMed 29250029Nogueira RG, Jadhav AP, Haussen DC, Bonafe A, Budzik RF, Bhuva P, Yavagal DR, Ribo M, Cognard C, Hanel RA, Sila CA, Hassan AE, Millan M, Levy EI, Mitchell P, Chen M, English JD, Shah QA, Silver FL, Pereira VM, Mehta BP, Baxter BW, Abraham MG, Cardona P, Veznedaroglu E, Hellinger FR, Feng L, Kirmani JF, Lopes DK, Jankowitz BT, Frankel MR, Costalat V, Vora NA, Yoo AJ, Malik AM, Furlan AJ, Rubiera M, Aghaebrahim A, Olivot JM, Tekle WG, Shields R, Graves T, Lewis RJ, Smith WS, Liebeskind DS, Saver JL, Jovin TG; DAWN Trial Investigators. Thrombectomy 6 to 24 Hours after Stroke with a Mismatch between Deficit and Infarct. N Engl J Med. 2018 Jan 4;378(1):11-21. doi: 10.1056/NEJMoa1706442. Epub 2017 Nov 11.
PubMed 29129157Gropen TI, Boehme A, Martin-Schild S, Albright K, Samai A, Pishanidar S, Janjua N, Brandler ES, Levine SR. Derivation and Validation of the Emergency Medical Stroke Assessment and Comparison of Large Vessel Occlusion Scales. J Stroke Cerebrovasc Dis. 2018 Mar;27(3):806-815. doi: 10.1016/j.jstrokecerebrovasdis.2017.10.018. Epub 2017 Nov 22.
PubMed 29174289Ghosh A, Nawabi NLA, Alcedo D, Alcedo Guardia RE, Vicenty-Padilla J, Izzy S, Patel NJ, Du R, Dmytriw AA, See AP, Aziz-Sultan MA, Gropen TI, Liebeskind D, Torio EF, Can A, Spanehl L, Gaude E, Bernstock JD. Prehospital Detection of Large Vessel Occlusion and Intracerebral Hemorrhage Using a Dual-Biomarker Point-of-Care Test. Stroke Vasc Interv Neurol. 2026 Mar 2;6(3):e002170. doi: 10.1161/SVIN.125.002170. eCollection 2026 May.
PubMed 42088320Durrani Y, Gerstl JVE, Murphy D, Harris A, Saali I, Gropen T, Shekhar S, Kappel AD, Patel NJ, Du R, Guardia REA, Vicenty-Padilla JC, Dmytriw AA, Pereira VM, Izzy S, Khan A, Aziz-Sultan MA, Liebeskind DS, Davies JM, Siddiqui AH, Gaude E, Bernstock JD. Prospective Validation of Glial Fibrillary Acidic Protein, d-Dimer, and Clinical Scales for Acute Large-Vessel Occlusion Ischemic Stroke Detection. Stroke Vasc Interv Neurol. 2024 May 17;4(4):e001304. doi: 10.1161/SVIN.123.001304. eCollection 2024 Jul.
PubMed 41585381
Study at a glance
From the registry record, last updated by the sponsor on 3 Apr 2023. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Testing of Identification Markers for Stroke
- ClinicalTrials.gov ID
- NCT04292600
- Acronym / sponsor ID
- TIME / POCKiT
- Conditions
- Stroke, Ischemic, Infarction, Middle Cerebral Artery, Infarction, Anterior Circulation, Brain
- Keywords
- large vessel occlusion strokes
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 383 participants (actual)
- Lead sponsor
- POCKiT diagnostics LtdIndustry (pharma, biotech, devices)
- Collaborators
- University of Alabama at Birmingham, University of Mississippi Medical Center, Bay Area Consulting Telemedicine
- Study start
- 1 May 2021 (actual)
- Primary completion
- 31 Aug 2022 (actual)
- Study completion
- 31 Jan 2023 (actual)
- First posted
- 3 Mar 2020 (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 third leading cause of death and the first cause of physical disability and dementia worldwide. Ischemic stroke caused by large vessel occlusion (LVO) is responsible for the vast majority of deaths and disabilities. A very effective and safe treatment, called mechanical thrombectomy (MT) is available for LVO patients. Nevertheless, no blood biomarkers able to identify LVO patients rapidly and to direct them to CT angiography and thrombectomy currently exist.
The TIME study is an observational prospective cohort study. All Patients referred to the emergency department or stroke unit with a suspected stroke as identified by paramedics, nurses or clinicians will be enrolled in the study. A panel of blood biomarkers will be analysed retrospectively via standard laboratory assays.
The main outcome of the TIME study will be the evaluation of the clinical diagnostic performance of a panel of blood biomarkers, in conjunction with clinical data, for the identification of large vessel occlusion ischemic stroke subtype. This study will allow the identification and evaluation of a final panel of biomarkers and will prompt the development of a test for LVO stroke diagnosis.
Detailed description
Stroke affects 16M people in the world every year and 100K in the UK only. More than 30% of these patients die and 90% of survivors develop permanent disabilities as a consequence of stroke. There are two main types of stroke, ischemic and haemorrhagic. Ischemic stroke is caused by the formation of a clot in a blood vessel in the brain and represents ~85% of stroke patients. Haemorrhagic stroke is due to the rupture of a blood vessel in the brain, with consequent bleeding, and it represents ~15% of stroke patients. Both stroke subtypes cause brain damage and their symptoms are very similar. In addition to these two types of stroke, among the population of suspected stroke patients, there are the so-called stroke "mimics". These are conditions that appear with stroke-like symptoms (e.g. migraine, epilepsy, encephalitis, etc) but that are not stroke.
The deadliest stroke subtype is the one caused by occlusion of large vessels (LVO) in the brain. For these patients, a new treatment is available, called thrombectomy, which is a surgical procedure that mechanically removes the clot via a probe inserted at the level of the groin. Treatment of LVO patients with mechanical thrombectomy (MT) significantly increases the chances of survival, as well as decreases the extent of disability1. MT is only available in comprehensive stroke centres (CSC), and LVO patients have to be transported specifically to CSC in order to be treated and increase their chances of survival. MT has been proven a safe and effective treatment for LVO stroke until 24 hours from stroke onset2, indicating that detection of LVO strokes several hours after onset can significantly aid the stroke care pathway.
Current treatment of stroke patients is dependent on diagnosis via computerised tomography (CT) scan to the head. CT is highly accurate for detection of brain haemorrhages, but is very inaccurate for detection of ischemic stroke or LVOs3. In case of a negative result from CT, neurologists can order a further MRI scan to confirm ischemic stroke. If LVO is suspected, patients are transported to the nearest CSC where a further procedure, called CT angiography, is performed. The identification of LVO patients can be a very lengthy process that wastes precious time and makes stroke patients worse.
Fast diagnosis of stroke patients at their first point of admission (i.e. ambulance or emergency department) able to identify LVO patients could quickly direct patients to CSC and significantly improve treatment of the most dangerous stroke subtype. Several studies have investigated the ability of pre-hospital assessment scores based on patient symptoms to be performed in the ambulance4-7. Despite this, these scoring scales lack the accuracy required for triaging LVO patients with confidence. A more accurate diagnostic test able to complement these assessment scores and direct LVO patients to CSC and CT angiography is much needed8.
POCKiT DX are developing a novel device for stroke diagnosis that combines accurate blood biomarkers with ultra-rapid (<20 minutes) biomarker detection within a point-of-care device. The panel of blood biomarkers identified by POCKiT DX was tested in 80 patients with suspected stroke and accuracy of 83% (CI 95%: 74-92%), sensitivity of 86% (CI 95%: 74-98%), and specificity of 82% (CI 95%: 68-95%) was observed for LVO identification.
The aim of the TIME study is to evaluate the clinical diagnostic performance of a panel of blood biomarkers identified by POCKiT diagnostics in the identification of LVO stroke patients among the population of suspected stroke. Diagnostic performance of blood biomarkers alone, and in conjunction with clinical data, including pre-hospital stroke assessment scores (e.g. EMSA), will be evaluated. Results of this study will direct the development of a diagnostic test for directing stroke patients to the right treatment, more rapidly, improving patient outcomes.
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| BRH | – | Diagnostic Test: POCKiT diagnostics' algorithm for LVO detectionCohort recruited at Brandon Regional Hospital by Bay Area Consulting Telemedicine |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- Patients admitted to the ambulance and ED with suspected stroke will be recruited in the study. Patient population is expected to be composed of ~50% ischemic strokes (of which ~30-40% could have LVOs), ~40% stroke mimics, and ~10% haemorrhagic strokes.
Key inclusion criteria (2 listed)
- Referred to the ambulance or emergency department for suspected stroke.
- Time from stroke onset < 18 hours
Key exclusion criteria (4 listed)
- Received thrombolytic therapy (e.g. tPA, Alteplase) before collection of blood;
- (Anticipated) inability to provide a blood sample;
- Time from stroke onset > 18 hours.
- At time of consent participating in a Clinical Trial Investigational Medicinal Product (CTIMP)
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 |
|---|---|---|
| POCKiT diagnostics' algorithm for LVO detectionMeasurement of blood biomarkers and integration within Pockit diagnostics' algorithm for LVO detection | Diagnostic test | BRH |
Primary outcome
Diagnostic accuracy measures for LVO detection vs non-LVO stroke activations
Time frame: 1 year
Accuracy of pre-defined algorithm thresholds for LVO identification from the population of all suspected strokes (Ischemics non-LVO, Hemorrhagic, Mimics, TIAs)
1 secondary outcome
Optimisation of the cut-off points of the diagnostic algorithm for LVO detection
Time frame: 1 year
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 3 Apr 2023.
- Background: PubMed 29250029Malhotra K, Gornbein J, Saver JL. Ischemic Strokes Due to Large-Vessel Occlusions Contribute Disproportionately to Stroke-Related Dependence and Death: A Review. Front Neurol. 2017 Nov 30;8:651. doi: 10.3389/fneur.2017.00651. eCollection 2017.
- Background: PubMed 29129157Nogueira RG, Jadhav AP, Haussen DC, Bonafe A, Budzik RF, Bhuva P, Yavagal DR, Ribo M, Cognard C, Hanel RA, Sila CA, Hassan AE, Millan M, Levy EI, Mitchell P, Chen M, English JD, Shah QA, Silver FL, Pereira VM, Mehta BP, Baxter BW, Abraham MG, Cardona P, Veznedaroglu E, Hellinger FR, Feng L, Kirmani JF, Lopes DK, Jankowitz BT, Frankel MR, Costalat V, Vora NA, Yoo AJ, Malik AM, Furlan AJ, Rubiera M, Aghaebrahim A, Olivot JM, Tekle WG, Shields R, Graves T, Lewis RJ, Smith WS, Liebeskind DS, Saver JL, Jovin TG; DAWN Trial Investigators. Thrombectomy 6 to 24 Hours after Stroke with a Mismatch between Deficit and Infarct. N Engl J Med. 2018 Jan 4;378(1):11-21. doi: 10.1056/NEJMoa1706442. Epub 2017 Nov 11.
- Background: PubMed 29174289Gropen TI, Boehme A, Martin-Schild S, Albright K, Samai A, Pishanidar S, Janjua N, Brandler ES, Levine SR. Derivation and Validation of the Emergency Medical Stroke Assessment and Comparison of Large Vessel Occlusion Scales. J Stroke Cerebrovasc Dis. 2018 Mar;27(3):806-815. doi: 10.1016/j.jstrokecerebrovasdis.2017.10.018. Epub 2017 Nov 22.
- Derived from this study: PubMed 42088320Ghosh A, Nawabi NLA, Alcedo D, Alcedo Guardia RE, Vicenty-Padilla J, Izzy S, Patel NJ, Du R, Dmytriw AA, See AP, Aziz-Sultan MA, Gropen TI, Liebeskind D, Torio EF, Can A, Spanehl L, Gaude E, Bernstock JD. Prehospital Detection of Large Vessel Occlusion and Intracerebral Hemorrhage Using a Dual-Biomarker Point-of-Care Test. Stroke Vasc Interv Neurol. 2026 Mar 2;6(3):e002170. doi: 10.1161/SVIN.125.002170. eCollection 2026 May.
- Derived from this study: PubMed 41585381Durrani Y, Gerstl JVE, Murphy D, Harris A, Saali I, Gropen T, Shekhar S, Kappel AD, Patel NJ, Du R, Guardia REA, Vicenty-Padilla JC, Dmytriw AA, Pereira VM, Izzy S, Khan A, Aziz-Sultan MA, Liebeskind DS, Davies JM, Siddiqui AH, Gaude E, Bernstock JD. Prospective Validation of Glial Fibrillary Acidic Protein, d-Dimer, and Clinical Scales for Acute Large-Vessel Occlusion Ischemic Stroke Detection. Stroke Vasc Interv Neurol. 2024 May 17;4(4):e001304. doi: 10.1161/SVIN.123.001304. eCollection 2024 Jul.
- Individual participant dataSharing planned: Undecided
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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.
Shashank Shekar, MD principal investigator
University of Mississippi Medical Center
Toby Gropen, MD principal investigator
University of Alabama in Birmingham Comprehensive Stroke Center
Allauddin Khan, MD principal investigator
BAC Telemed (Brandon Regional Hospital)
3 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, Ischemic and Infarction, Middle Cerebral Artery, run by POCKiT diagnostics Ltd at 3 sites in United States.
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 2 inclusion and 4 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 3 Apr 2023. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 3 sites in United States. 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?
Diagnostic accuracy measures for LVO detection vs non-LVO stroke activations (time frame: 1 year). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT04292600, which also lists 5 linked publications.
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 3 Apr 2023.