Acute Stroke
Conditions
Keywords
Acute Stroke, Ischemic Stroke, LVOne Test, Diagnosis, Large Vessel Occlusion (LVO), Glial Fibrillary Acidic Protein (GFAP), D-dimer
Brief 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 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.
Interventions
DIAGNOSTIC_TESTDiagnostic standard of care
Participants will receive the diagnostic standard of care: standard laboratory workup, non-contrast brain CT, brain CTA, brain CTP, or brain MRI.
DIAGNOSTIC_TESTLVOne Test
Participants will receive the LVOne test, which will measure D-dimer and Glial Fibrillary Acidic Protein (GFAP) levels to diagnose acute stroke.
Sponsors
University of Puerto Rico
Mennonite Health System
Juan Vicenty
Study design
Allocation
RANDOMIZED
Intervention model
CROSSOVER
Primary purpose
DIAGNOSTIC
Masking
SINGLE (Outcomes Assessor)
Masking description
The neuro-radiologist(s) who will read patient brain imaging and the expert stroke clinician(s) who will assign a clinical outcome (reference standard) will be blinded to the LVOne test results. Due to the nature of the LVOne and the management implications of a positive test, hospital clinicians will not be blinded to these results.
Intervention 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.
Eligibility
Sex/Gender
ALL
Age
21 Years to 85 Years
Healthy volunteers
No
Inclusion criteria
* 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
Exclusion criteria
* 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
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Change in the time from triage assessment to thrombectomy puncture | 24 hours | The difference in time from the participant triage assessment to thrombectomy puncture. |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Time from HUB hospital triage assessment to LVOne test in intervention | 24 hours | The difference in time from the HUB hospital triage assessment to the performance of the LVOne test. |
| Time from HUB hospital triage assessment to thrombectomy puncture | 24 hours | The difference in time from the HUB hospital triage assessment to the thrombectomy puncture. |
| Thrombectomy rate (proportion of treated LVO) | 24 hours | The number of participants that received thrombectomy. |
| Length of hospital stay | 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 | The participant's hospitalization period. |
| Time from spoke hospital triage assessment to LVOne test in intervention | 24 hours | Difference in time from triage assessment to the performance of the LVOne test in the intervention group. |
| Diagnostic accuracy for LVO detection | At the time of initial assessment and confirmed by diagnostic imaging within 24 hours | 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. |
| Diagnostic accuracy for intracerebral hemorrhage detection | At the time of initial assessment and confirmed by diagnostic imaging within 24 hours | 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. |
| Modified Rankin Scale (mRS) | At the time of initial assessment, 24 hours, at discharge, 3 months, 6 months, and 12 months | 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). |
| Length of ICU stay | 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 | The participant's hospitalization period in the intensive care unit (ICU). |
Countries
Puerto Rico
Contacts
Primary ContactMaria M Garcia Perez
Outcome results
None listed