Acute StrokeCOPILOTNCT06910163
Direct-to-angio Approach From loCal hOspitals Based on a PoInt-of-care bLOod Test for LVO
A study testing LVOne Test in people with Acute Stroke, run by Juan Vicenty at 1 site in Puerto Rico.
Trial summary
Direct-to-angio approach from loCal hOspitals based on a PoInt-of-care bLOod Test for LVO (COPILOT) is a multi-center, prospective, cluster-randomized crossover trial that will evaluate if the triage assessment to thrombectomy puncture time is shorter after performing the LVOne testing compared to current management… Read more about this study
- Who is it for?
- Ages 21 to 85 years
- Conditions the study is for
- Acute Stroke
- What is being tested?
- LVOne Test
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 520 participants
- Where
- 1 sitePuerto Rico
- Study dates
- May 2025to Aug 2028
- Phase
- Interventional
- Are there results?
- Not yet: the study is under way
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 21 to 85 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Age: 21 to 85 years old
- Language: Speak and understand Spanish or English
- Residence: Resident of Puerto Rico
- Clinical presentation: Suspected acute stroke
- Time of presentation: Monday to Friday, between 8:00 a.m. and 4:00 p.m.
- Time of symptom onset: symptoms are known to have begun within the last 6 hours, OR last known to be well between 6 and 18 hours ago, confirmed by a reliable witness or healthcare professional
Who cannot join
- Previous healthcare encounter:
- Already assessed at another hospital, and ambulance admission is a transfer for continuing care OR
- Received thrombolysis therapy before consent (e.g., tPA, alteplase)
- Medical History: diagnosed with any of the following in the past 4 weeks: deep vein thrombosis (DVT), pulmonary embolism (PE), arterial embolism, stroke, transient ischemic attack (TIA), long bone fracture, major trauma, surgery under general anesthesia, or head injury requiring hospital admission within the last 4 weeks.
- Modified Rankin Scale: Pre-stroke mRS ≥ 3
- The patient is a pregnant woman
- The patient is under legal custody or deprived of liberty in penitentiary institutions
- The patient is unable to provide informed consent on their own and whose authorized legal representatives are unavailable in person or by telephone during recruitment
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
About this study
Official title: Direct-to-angio Approach From loCal hOspitals Based on a PoInt-of-care bLOod Test for LVO (COPILOT): an Effectiveness Cluster Randomized Crossover Trial
Direct-to-angio approach from loCal hOspitals based on a PoInt-of-care bLOod Test for LVO (COPILOT) is a multi-center, prospective, cluster-randomized crossover trial that will evaluate if the triage assessment to thrombectomy puncture time is shorter after performing the LVOne testing compared to current management standards in patients with suspected large vessel occlusion.
Read the detailed description
The COPILOT trial utilizes a cluster randomized crossover design within the Sistema de Salud Menonita (SSM) hospital network to evaluate if early detection of large vessel occlusion (LVO) stroke with a novel blood test can accelerate the time from triage assessment to thrombectomy puncture. It will unfold in three phases:
Phase 0 - Baseline Data Collection (3 months): Before the random allocation, all clusters undergo data collection on baseline characteristics and outcome measures to confirm/set a pre-intervention comparison ground. Phase 0 patients will receive the current standard of care. An interim analysis will check recruitment rates and explore the need for additional clusters for adequate study power.
Phase 1 - Intervention and Control (12 months): Clusters are randomized to either the intervention or control group, with the intervention arm implementing the LVOne test and the control arm continuing standard care without the LVOne test. Data analysts remain blinded to group allocation, while an interim analysis revisits recruitment and primary outcomes to assess whether additional clusters are required.
Phase 2 - Crossover (12 months): Clusters switch roles from Phase 1, allowing every cluster to experience both the intervention and control conditions, facilitating within-cluster comparisons. The nature of the intervention prevents the blinding of participants and staff.
- Conditions
- Acute Stroke
- Being tested
- Diagnostic standard of care, LVOne Test
- Keywords
- Acute Stroke, Ischemic Stroke, LVOne Test, Diagnosis, Large Vessel Occlusion (LVO), Glial Fibrillary Acidic Protein (GFAP), D-dimer
- Medical subject headings
- Stroke, Ischemic Stroke, Disease
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Diagnostic standard of careDiagnostic test
Participants will receive the diagnostic standard of care: standard laboratory workup, non-contrast brain CT, brain CTA, brain CTP, or brain MRI.
LVOne TestDiagnostic test
Participants will receive the LVOne test, which will measure D-dimer and Glial Fibrillary Acidic Protein (GFAP) levels to diagnose acute stroke.
| Study group | Role | What they receive |
|---|---|---|
| Standard of Care | Active comparator | Participants will receive the current diagnostic standard of care. Receives: Diagnostic Test: Diagnostic standard of care |
| LVOne Test | Experimental | Participants will receive the LVOne test alongside the current standard of care. Receives: Diagnostic Test: Diagnostic standard of care; Diagnostic Test: LVOne Test |
What is being measured
The primary outcome is the main question the study is designed to answer.
Change in the time from triage assessment to thrombectomy puncture
The difference in time from the participant triage assessment to thrombectomy puncture.
Measured: 24 hours
Secondary outcomes (9)
Time from spoke hospital triage assessment to LVOne test in intervention
Difference in time from triage assessment to the performance of the LVOne test in the intervention group.
Measured: 24 hours
Time from HUB hospital triage assessment to LVOne test in intervention
The difference in time from the HUB hospital triage assessment to the performance of the LVOne test.
Measured: 24 hours
Time from HUB hospital triage assessment to thrombectomy puncture
The difference in time from the HUB hospital triage assessment to the thrombectomy puncture.
Measured: 24 hours
Thrombectomy rate (proportion of treated LVO)
The number of participants that received thrombectomy.
Measured: 24 hours
Length of hospital stay
The participant's hospitalization period.
Measured: From date of randomization until the date of discharge or date of death from any cause while patient is in hospital, whichever came first, assessed up to 30 days
Length of ICU stay
The participant's hospitalization period in the intensive care unit (ICU).
Measured: From date of randomization until the date of discharge or date of death from any cause while patient is in hospital, whichever came first, assessed up to 30 days
Diagnostic accuracy for LVO detection
The ability of the test to correctly identify large vessel occlusion (LVO) in patients with suspected acute ischemic stroke. Diagnostic accuracy will be assessed by comparing the test results to the reference imaging standards.
Measured: At the time of initial assessment and confirmed by diagnostic imaging within 24 hours
Diagnostic accuracy for intracerebral hemorrhage detection
The ability of the LVOne test to correctly detect intracerebral hemorrhage (ICH) in patients presenting with acute stroke symptoms. Diagnostic accuracy will be determined by comparing LVOne test results to diagnostic imaging.
Measured: At the time of initial assessment and confirmed by diagnostic imaging within 24 hours
Modified Rankin Scale (mRS)
The modified Rankin Scale (mRS) is a measure of functional outcome assessing the degree of disability or dependence in daily activities. The scale ranges from 0 (no symptoms) to 6 (death).
Measured: At the time of initial assessment, 24 hours, at discharge, 3 months, 6 months, and 12 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted4 Apr 2025
- Study startMay 2025 (estimated)
- Primary completionAug 2027 (estimated)
- Study completionAug 2028 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (12)Papers the sponsor has linked to this study.
- Other trials for Acute 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
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Diagnosis
- Allocation
- Randomised
- Intervention model
- Crossover
- Model description
- The COPILOT trial, a cluster randomized crossover study within the Sistema de Salud Menonita (SSM) hospital network, evaluates whether early detection of large vessel occlusion (LVO) stroke via a novel blood test accelerates triage-to-thrombectomy time. Phase 0 (3 months): Baseline data collection to establish pre-intervention comparisons. Patients receive standard care, and an interim analysis assesses recruitment and study power. Phase 1 (12 months): Clusters are randomized to intervention (LVOne test) or control (standard care). Analysts remain blinded, and interim analysis reassesses recruitment and primary outcomes. Phase 2 (12 months): Clusters switch roles, enabling within-cluster comparisons. Due to the intervention's nature, participants and staff cannot be blinded.
- Masking
- Single blind
- Who is masked
- Outcomes assessor
- Enrolment
- 520 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Juan Vicenty
- Sponsor type
- University, hospital or other
- Collaborators
- University of Puerto Rico, Mennonite Health System
- Responsible party
- Sponsor-investigator, Juan Vicenty, University of Puerto Rico
- Investigators
- Juan C Vicenty Padilla, MD, Principal investigator, University of Puerto Rico Medical Sciences Campus
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06910163
- Sponsor's protocol ID
- 2410303013
- Acronym
- COPILOT
- Status last verified
- Mar 2025
- First submitted
- 27 Mar 2025
- Last updated
- 4 Apr 2025
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- Yes
- Individual data sharing
- No
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 29250029Victor P, Bian E, Mamdouh H, Mohamed GA, Nour HA, Miller K, Singh K, Patel S, Segovis C, Nahab F. Upfront vascular imaging in acute stroke: Impact on thrombectomy transfer time at a primary stroke center. J Stroke Cerebrovasc Dis. 2024 Aug;33(8):107815. doi: 10.1016/j.jstrokecerebrovasdis.2024.107815. Epub 2024 Jun 13.
PubMed 38878844Saver JL. Time is brain--quantified. Stroke. 2006 Jan;37(1):263-6. doi: 10.1161/01.STR.0000196957.55928.ab. Epub 2005 Dec 8.
PubMed 16339467Durrani 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 41585381Gaude E, Nogueira B, Ladreda Mochales M, Graham S, Smith S, Shaw L, Graziadio S, Ladreda Mochales G, Sloan P, Bernstock JD, Shekhar S, Gropen TI, Price CI. A Novel Combination of Blood Biomarkers and Clinical Stroke Scales Facilitates Detection of Large Vessel Occlusion Ischemic Strokes. Diagnostics (Basel). 2021 Jun 22;11(7):1137. doi: 10.3390/diagnostics11071137.
PubMed 34206615Kothari RU, Brott T, Broderick JP, Barsan WG, Sauerbeck LR, Zuccarello M, Khoury J. The ABCs of measuring intracerebral hemorrhage volumes. Stroke. 1996 Aug;27(8):1304-5. doi: 10.1161/01.str.27.8.1304.
PubMed 8711791Puetz V, Dzialowski I, Hill MD, Subramaniam S, Sylaja PN, Krol A, O'Reilly C, Hudon ME, Hu WY, Coutts SB, Barber PA, Watson T, Roy J, Demchuk AM; Calgary CTA Study Group. Intracranial thrombus extent predicts clinical outcome, final infarct size and hemorrhagic transformation in ischemic stroke: the clot burden score. Int J Stroke. 2008 Nov;3(4):230-6. doi: 10.1111/j.1747-4949.2008.00221.x.
PubMed 18811738Bamford J. Clinical examination in diagnosis and subclassification of stroke. Lancet. 1992 Feb 15;339(8790):400-2. doi: 10.1016/0140-6736(92)90085-h. No abstract available.
PubMed 1346666van Swieten JC, Koudstaal PJ, Visser MC, Schouten HJ, van Gijn J. Interobserver agreement for the assessment of handicap in stroke patients. Stroke. 1988 May;19(5):604-7. doi: 10.1161/01.str.19.5.604.
PubMed 3363593Barber PA, Demchuk AM, Zhang J, Buchan AM. Validity and reliability of a quantitative computed tomography score in predicting outcome of hyperacute stroke before thrombolytic therapy. ASPECTS Study Group. Alberta Stroke Programme Early CT Score. Lancet. 2000 May 13;355(9216):1670-4. doi: 10.1016/s0140-6736(00)02237-6.
PubMed 10905241Goyal M, Fargen KM, Turk AS, Mocco J, Liebeskind DS, Frei D, Demchuk AM. 2C or not 2C: defining an improved revascularization grading scale and the need for standardization of angiography outcomes in stroke trials. J Neurointerv Surg. 2014 Mar;6(2):83-6. doi: 10.1136/neurintsurg-2013-010665. Epub 2013 Feb 6. No abstract available.
PubMed 23390038Menon BK, Smith EE, Modi J, Patel SK, Bhatia R, Watson TW, Hill MD, Demchuk AM, Goyal M. Regional leptomeningeal score on CT angiography predicts clinical and imaging outcomes in patients with acute anterior circulation occlusions. AJNR Am J Neuroradiol. 2011 Oct;32(9):1640-5. doi: 10.3174/ajnr.A2564. Epub 2011 Jul 28.
PubMed 21799045
Study at a glance
From the registry record, last updated by the sponsor on 4 Apr 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Direct-to-angio Approach From loCal hOspitals Based on a PoInt-of-care bLOod Test for LVO (COPILOT): an Effectiveness Cluster Randomized Crossover Trial
- ClinicalTrials.gov ID
- NCT06910163
- Acronym / sponsor ID
- COPILOT / 2410303013
- Conditions
- Acute Stroke
- Keywords
- Acute Stroke, Ischemic Stroke, LVOne Test, Diagnosis, Large Vessel Occlusion (LVO), Glial Fibrillary Acidic Protein (GFAP), D-dimer
- Study type
- Interventional
- Recruitment status
- Not yet recruiting
- Enrolment
- 520 participants (estimated)
- Lead sponsor
- Juan VicentyUniversity, hospital or other
- Collaborators
- University of Puerto Rico, Mennonite Health System
- Study start
- May 2025 (estimated)
- Primary completion
- Aug 2027 (estimated)
- Study completion
- Aug 2028 (estimated)
- First posted
- 4 Apr 2025 (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.
Direct-to-angio approach from loCal hOspitals based on a PoInt-of-care bLOod Test for LVO (COPILOT) is a multi-center, prospective, cluster-randomized crossover trial that will evaluate if the triage assessment to thrombectomy puncture time is shorter after performing the LVOne testing compared to current management standards in patients with suspected large vessel occlusion.
Detailed description
The COPILOT trial utilizes a cluster randomized crossover design within the Sistema de Salud Menonita (SSM) hospital network to evaluate if early detection of large vessel occlusion (LVO) stroke with a novel blood test can accelerate the time from triage assessment to thrombectomy puncture. It will unfold in three phases:
Phase 0 - Baseline Data Collection (3 months): Before the random allocation, all clusters undergo data collection on baseline characteristics and outcome measures to confirm/set a pre-intervention comparison ground. Phase 0 patients will receive the current standard of care. An interim analysis will check recruitment rates and explore the need for additional clusters for adequate study power.
Phase 1 - Intervention and Control (12 months): Clusters are randomized to either the intervention or control group, with the intervention arm implementing the LVOne test and the control arm continuing standard care without the LVOne test. Data analysts remain blinded to group allocation, while an interim analysis revisits recruitment and primary outcomes to assess whether additional clusters are required.
Phase 2 - Crossover (12 months): Clusters switch roles from Phase 1, allowing every cluster to experience both the intervention and control conditions, facilitating within-cluster comparisons. The nature of the intervention prevents the blinding of participants and staff.
Study design
- Primary purpose
- Diagnosis
- Allocation
- Randomised
- Intervention model
- Crossover
- Masking
- Single blind (outcomes assessor)
- Number of arms
- 2
- Model description
- The COPILOT trial, a cluster randomized crossover study within the Sistema de Salud Menonita (SSM) hospital network, evaluates whether early detection of large vessel occlusion (LVO) stroke via a novel blood test accelerates triage-to-thrombectomy time. Phase 0 (3 months): Baseline data collection to establish pre-intervention comparisons. Patients receive standard care, and an interim analysis assesses recruitment and study power. Phase 1 (12 months): Clusters are randomized to intervention (LVOne test) or control (standard care). Analysts remain blinded, and interim analysis reassesses recruitment and primary outcomes. Phase 2 (12 months): Clusters switch roles, enabling within-cluster comparisons. Due to the intervention's nature, participants and staff cannot be blinded.
| Arm | Type | Receives |
|---|---|---|
| Standard of Care | Active comparator | Diagnostic Test: Diagnostic standard of careParticipants will receive the current diagnostic standard of care. |
| LVOne Test | Experimental | Diagnostic Test: Diagnostic standard of care, Diagnostic Test: LVOne TestParticipants will receive the LVOne test alongside the current standard of care. |
Who may qualify
- Ages
- 21 to 85 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (6 listed)
- Age: 21 to 85 years old
- Language: Speak and understand Spanish or English
- Residence: Resident of Puerto Rico
- Clinical presentation: Suspected acute stroke
- Time of presentation: Monday to Friday, between 8:00 a.m. and 4:00 p.m.
Key exclusion criteria (8 listed)
- Previous healthcare encounter:
- Already assessed at another hospital, and ambulance admission is a transfer for continuing care OR
- Received thrombolysis therapy before consent (e.g., tPA, alteplase)
- Medical History: diagnosed with any of the following in the past 4 weeks: deep vein thrombosis (DVT), pulmonary embolism (PE), arterial embolism, stroke, transient ischemic attack (TIA), long bone fracture, major trauma, surgery under general anesthesia, or head injury requiring hospital admission within the last 4 weeks.
- Modified Rankin Scale: Pre-stroke mRS ≥ 3
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 |
|---|---|---|
| Diagnostic standard of careParticipants will receive the diagnostic standard of care: standard laboratory workup, non-contrast brain CT, brain CTA, brain CTP, or brain MRI. | Diagnostic test | LVOne Test, Standard of Care |
| LVOne TestParticipants will receive the LVOne test, which will measure D-dimer and Glial Fibrillary Acidic Protein (GFAP) levels to diagnose acute stroke. | Diagnostic test | LVOne Test |
Primary outcome
Change in the time from triage assessment to thrombectomy puncture
Time frame: 24 hours
The difference in time from the participant triage assessment to thrombectomy puncture.
9 secondary outcomes
Time from spoke hospital triage assessment to LVOne test in intervention
Time frame: 24 hours
Time from HUB hospital triage assessment to LVOne test in intervention
Time frame: 24 hours
Time from HUB hospital triage assessment to thrombectomy puncture
Time frame: 24 hours
Thrombectomy rate (proportion of treated LVO)
Time frame: 24 hours
Length of hospital stay
Time frame: From date of randomization until the date of discharge or date of death from any cause while patient is in hospital, whichever came first, assessed up to 30 days
Length of ICU stay
Time frame: From date of randomization until the date of discharge or date of death from any cause while patient is in hospital, whichever came first, assessed up to 30 days
Diagnostic accuracy for LVO detection
Time frame: At the time of initial assessment and confirmed by diagnostic imaging within 24 hours
Diagnostic accuracy for intracerebral hemorrhage detection
Time frame: At the time of initial assessment and confirmed by diagnostic imaging within 24 hours
Modified Rankin Scale (mRS)
Time frame: At the time of initial assessment, 24 hours, at discharge, 3 months, 6 months, and 12 months
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 4 Apr 2025.
- 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 38878844Victor P, Bian E, Mamdouh H, Mohamed GA, Nour HA, Miller K, Singh K, Patel S, Segovis C, Nahab F. Upfront vascular imaging in acute stroke: Impact on thrombectomy transfer time at a primary stroke center. J Stroke Cerebrovasc Dis. 2024 Aug;33(8):107815. doi: 10.1016/j.jstrokecerebrovasdis.2024.107815. Epub 2024 Jun 13.
- Background: PubMed 16339467Saver JL. Time is brain--quantified. Stroke. 2006 Jan;37(1):263-6. doi: 10.1161/01.STR.0000196957.55928.ab. Epub 2005 Dec 8.
- Background: 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.
- Background: PubMed 34206615Gaude E, Nogueira B, Ladreda Mochales M, Graham S, Smith S, Shaw L, Graziadio S, Ladreda Mochales G, Sloan P, Bernstock JD, Shekhar S, Gropen TI, Price CI. A Novel Combination of Blood Biomarkers and Clinical Stroke Scales Facilitates Detection of Large Vessel Occlusion Ischemic Strokes. Diagnostics (Basel). 2021 Jun 22;11(7):1137. doi: 10.3390/diagnostics11071137.
- Background: PubMed 8711791Kothari RU, Brott T, Broderick JP, Barsan WG, Sauerbeck LR, Zuccarello M, Khoury J. The ABCs of measuring intracerebral hemorrhage volumes. Stroke. 1996 Aug;27(8):1304-5. doi: 10.1161/01.str.27.8.1304.
- Background: PubMed 18811738Puetz V, Dzialowski I, Hill MD, Subramaniam S, Sylaja PN, Krol A, O'Reilly C, Hudon ME, Hu WY, Coutts SB, Barber PA, Watson T, Roy J, Demchuk AM; Calgary CTA Study Group. Intracranial thrombus extent predicts clinical outcome, final infarct size and hemorrhagic transformation in ischemic stroke: the clot burden score. Int J Stroke. 2008 Nov;3(4):230-6. doi: 10.1111/j.1747-4949.2008.00221.x.
- Background: PubMed 1346666Bamford J. Clinical examination in diagnosis and subclassification of stroke. Lancet. 1992 Feb 15;339(8790):400-2. doi: 10.1016/0140-6736(92)90085-h. No abstract available.
- Background: PubMed 3363593van Swieten JC, Koudstaal PJ, Visser MC, Schouten HJ, van Gijn J. Interobserver agreement for the assessment of handicap in stroke patients. Stroke. 1988 May;19(5):604-7. doi: 10.1161/01.str.19.5.604.
- Background: PubMed 10905241Barber PA, Demchuk AM, Zhang J, Buchan AM. Validity and reliability of a quantitative computed tomography score in predicting outcome of hyperacute stroke before thrombolytic therapy. ASPECTS Study Group. Alberta Stroke Programme Early CT Score. Lancet. 2000 May 13;355(9216):1670-4. doi: 10.1016/s0140-6736(00)02237-6.
- Background: PubMed 23390038Goyal M, Fargen KM, Turk AS, Mocco J, Liebeskind DS, Frei D, Demchuk AM. 2C or not 2C: defining an improved revascularization grading scale and the need for standardization of angiography outcomes in stroke trials. J Neurointerv Surg. 2014 Mar;6(2):83-6. doi: 10.1136/neurintsurg-2013-010665. Epub 2013 Feb 6. No abstract available.
- Background: PubMed 21799045Menon BK, Smith EE, Modi J, Patel SK, Bhatia R, Watson TW, Hill MD, Demchuk AM, Goyal M. Regional leptomeningeal score on CT angiography predicts clinical and imaging outcomes in patients with acute anterior circulation occlusions. AJNR Am J Neuroradiol. 2011 Oct;32(9):1640-5. doi: 10.3174/ajnr.A2564. Epub 2011 Jul 28.
- Individual participant dataSharing planned: No
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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.
Juan C Vicenty Padilla, MD principal investigator
University of Puerto Rico Medical Sciences Campus
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing LVOne Test in people with Acute Stroke, run by Juan Vicenty at 1 site in Puerto Rico.
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 6 inclusion and 8 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: opening soon, as of the sponsor's last update on 4 Apr 2025. 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 Puerto Rico. 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?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Maria M Garcia Perez (939-417-4432, dra.garcia.neurosx@gmail.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Change in the time from triage assessment to thrombectomy puncture (time frame: 24 hours). 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 NCT06910163, which also lists 12 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 4 Apr 2025.