Glial Fibrillary Acidic Protein Testing and Handheld Near Infrared Spectroscopy Technology CEREBO in India.
Prehospital Rapid Evaluation and Detection in Cerebrovascular Triage: A Multicenter Study of Glial Fibrillary Acidic Protein Point of Care Testing and Handheld Near Infrared Spectroscopy Technology CEREBO in India.
CEREBO is an ICMR award winning point-of-care (POC) adjunct CT scanning device for detecting brain hematomas in patients with head injury. The study aims to validate the diagnostic accuracy of the PREDICT Assessment Model (CEREBO-NIRS plus GFAP/D-Dimer POC Assay) in patients with suspected stroke. The study will be conducted as part of the Indian Council of Medical Research's National Health Research Priority (ICMR-NHRP) under the INDIA-EMS project using a two phase design.
PHASE I: Validation of a diagnostic accuracy and feasbility of PREDICT assessment model (a combined approach using GFAP/ D-dimer POC lateral flow assay plus CEREBO-NIRS technology).
Study Design: Prospective, Multicenter, Validation and Feasibility Study.
PHASE II: Pilot RCT to assess integration of the PREDICT assessment model into pre-hospital pathways.
Study Design: Pilot Randomized Controlled Trial (RCT) (Year 3-5)
Descripción general del estudio
Estado
Condiciones
Descripción detallada
This study, titled "Prehospital Rapid Evaluation and Detection in Cerebrovascular Triage: A Multicenter Study of Glial Fibrillary Acidic Protein Point-of-Care Testing and Handheld Near-Infrared Spectroscopy Technology (CEREBO) in India," aims to validate the PREDICT Assessment Model, which combines GFAP/D-Dimer point-of-care testing with handheld CEREBO Near-Infrared Spectroscopy (NIRS) technology for the rapid differentiation of ischemic stroke and intracerebral hemorrhage in the prehospital setting.
The study will be conducted under the Indian Council of Medical Research (ICMR) National Health Research Priority (NHRP) programme as part of the INDIA-EMS project and will use a two-phase design. Phase I is a prospective, multicenter validation and feasibility study involving patients with suspected acute stroke presenting by ambulance or directly to the emergency department. Participants will undergo clinical assessment, including BE-FAST and neurological assessment, finger-prick blood testing for GFAP/D-Dimer, and CEREBO-NIRS assessment. All participants will subsequently undergo standard diagnostic evaluation with a CT head scan, which will serve as the gold standard for stroke subtype classification. The diagnostic accuracy, feasibility, process times, and safety of the combined PREDICT Assessment Model will be evaluated.
Phase II will be a pilot randomized controlled trial evaluating the integration of the PREDICT Assessment Model into prehospital stroke pathways. Ambulance services within the catchment areas of CMC Ludhiana and JIPMER Puducherry will be randomized to intervention or control groups. In the intervention group, ambulance personnel will use GFAP/D-Dimer testing and CEREBO-NIRS technology to support prehospital stroke classification and triage, in coordination with the on-call stroke team. The control group will receive standard care, including transport to the hospital for CT-based diagnosis and subsequent treatment decisions.
The primary objective of the study is to validate the diagnostic accuracy and feasibility of the combined GFAP/D-Dimer and CEREBO-NIRS approach and to assess its potential impact on prehospital stroke triage. Phase II will additionally assess the effect of the intervention on the time from ambulance dispatch to initiation of stroke-specific treatment. Secondary outcomes include functional outcome at 90 days measured by the modified Rankin Scale, in-hospital mortality, and adverse events.
Tipo de estudio
Inscripción (Estimado)
Fase
- No aplica
Contactos y Ubicaciones
Estudio Contacto
- Nombre: Dr Ivy A Sebastian
- Número de teléfono: 09592588138
- Correo electrónico: ivy29cmc@gmail.com
Copia de seguridad de contactos de estudio
- Nombre: Dr Jeyaraj D Pandian, MD DM
- Número de teléfono: 9915784750
- Correo electrónico: jeyarajpandian@hotmail.com
Ubicaciones de estudio
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Puducherry
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Puducherry, Puducherry, India, 605006
- Jawaharlal Institute of Postgraduate Medical Education and Research Puducherry JIPMER
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Contacto:
- Dr Manu Ayyan
- Número de teléfono: 9846556133
- Correo electrónico: manuayyan@hotmail.com
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Punjab
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Ludhiana, Punjab, India, 141008
- Christian Medical College and Hospital
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Contacto:
- Dr Ivy A Sebastian
- Número de teléfono: 9999464986
- Correo electrónico: ivy29cmc@gmail.com
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Criterios de participación
Criterio de elegibilidad
Edades elegibles para estudiar
Acepta Voluntarios Saludables
Géneros elegibles para el estudio
Descripción
Phase 1
Inclusion criteria
- Adult patients of any gender ≥18 years with clinically suspected stroke
- Transported by ambulance or presenting directly to ED of participating hospitals
- Time from symptom onset/ Lost known well time (within 24 hours)
- Consent provided by patient/ next of kin
Exclusion criteria:
- Patients with known pre-existing neurological conditions that may confound diagnosis (Concurrent traumatic brain injury, recent TBI in last 3months, IS/ICH in last 3 months, Diagnosis of brain tumour/SOL)
- Patients with known medical condition with estimated life expectancy ≤ 3 months
- Those refusing consent
Phase 2
Inclusion criteria:
- Adult patients of any gender ≥18 years with clinically suspected stroke
- Transported by ambulance to ED of participating hospitals
- Time from symptom onset/ Last well known time (≤ 24 hours)
- NIHSS ≥ 5
- Consent provided by patient/ next of kin
Exclusion criteria:
- Patients with known pre-existing neurological conditions that may confound diagnosis (Concurrent traumatic brain injury, recent TBI in last 3months, IS/ ICH in last 3 months, Diagnosis of brain tumour/ SOL)
- Patients with known medical condition with estimated life expectancy ≤ 3 months
- Those refusing consent
Plan de estudios
¿Cómo está diseñado el estudio?
Detalles de diseño
- Propósito principal: Diagnóstico
- Asignación: Aleatorizado
- Modelo Intervencionista: Asignación paralela
- Enmascaramiento: Ninguno (etiqueta abierta)
Armas e Intervenciones
Grupo de participantes/brazo |
Intervención / Tratamiento |
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Experimental: PREDICT Assessment Model
Ambulances in the intervention group will use the GFAP/D-Dimer point-of-care test and CEREBO Near-Infrared Spectroscopy (NIRS) technology to classify suspected acute stroke in the prehospital setting. Patients suspected of ischemic stroke and large vessel occlusion will be rapidly triaged to a comprehensive stroke centre, while patients suspected of intracerebral hemorrhage will receive stringent blood pressure control in the ambulance according to established protocols. Decision-making will be undertaken in conjunction with the on-call stroke team through the PREDICT App. |
Prueba de diagnóstico: GFAP/D-Dimer Point-of-Care Testing & CEREBO Near-Infrared Spectroscopy (NIRS)
A finger-prick blood sample will be obtained from patients with suspected acute stroke and tested using a GFAP/D-Dimer lateral flow assay. The test will provide rapid biomarker results to support differentiation between ischemic stroke and intracerebral hemorrhage in the prehospital setting and The handheld CEREBO-NIRS device will be applied non-invasively to the patient's scalp to detect intracranial hematoma by assessing asymmetry in near-infrared optical density. The findings will be recorded and used as part of the PREDICT Assessment Model for stroke subtype classification. |
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Comparador activo: Standard Care
Ambulances in the control group will follow standard care procedures, including rapid transport of patients to the hospital for CT head imaging, followed by treatment decisions based on the CT findings. |
Standard care CT head imaging |
¿Qué mide el estudio?
Medidas de resultado primarias
Medida de resultado |
Medida Descripción |
Periodo de tiempo |
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PREDICT assessment model
Periodo de tiempo: 30 mins
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(Phase 1) Sensitivity and Specificity and PREDICT assessment model. Accurate identification of ICH >90% using PREDICT model. |
30 mins
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Time for Device Application by Paramedics
Periodo de tiempo: 30 mins
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(Phase 1) The time taken by paramedics/ ED personnel to apply the CEREBO NIRS device and obtain GFAP/D Dimer results. Lesser time indicates good outcome. |
30 mins
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Treatment initiation
Periodo de tiempo: 30 mins
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(Phase 2) Time from Ambulance dispatch to initiation of stroke-specific treatment (Triage to Stroke ready centre or rapid BP control). Lesser time indicates better outcome. |
30 mins
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Medidas de resultado secundarias
Medida de resultado |
Medida Descripción |
Periodo de tiempo |
|---|---|---|
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Inter-Center Variability
Periodo de tiempo: 2 years
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(Phase 1) Comparison of diagnostic accuracy and feasibility metrics between CMC Ludhiana and JIPMER Puducherry to assess consistency across centres. More consistency indicates good outcome. |
2 years
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Correlation with Gold Standard
Periodo de tiempo: 2 years
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(Phase 1) Agreement between the PREDICT assessment model and the CT head scan diagnosis (the gold standard). More correlation indicates better outcome. |
2 years
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Safety Metrics
Periodo de tiempo: 2 years
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Phase 1 Documentation of adverse events related to the testing procedure. Fewer events indicate a better outcome. |
2 years
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modified Rankin Scale
Periodo de tiempo: 90 days
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Phase 2 Functional outcome at 90 days Lower score (0-3) indicates good outcome |
90 days
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In-hospital mortality
Periodo de tiempo: 7 days
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Phase 2 In-hospital mortality. Lesser mortality indicates better outcome |
7 days
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Adverse events
Periodo de tiempo: 90 days
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Phase 2 Incidence of adverse events (e.g., symptomatic ICH). Lesser events indicate better outcome. |
90 days
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Colaboradores e Investigadores
Colaboradores
Investigadores
- Investigador principal: Dr Ivy A Sebastian, Christian Medical College and Hospital, Ludhiana, India
- Investigador principal: Dr Jeyaraj D Pandian, MD DM, Christian Medical College and Hospital, Ludhiana, India
Publicaciones y enlaces útiles
Publicaciones Generales
- Ma L, Hu X, Song L, Chen X, Ouyang M, Billot L, Li Q, Malavera A, Li X, Munoz-Venturelli P, de Silva A, Thang NH, Wahab KW, Pandian JD, Wasay M, Pontes-Neto OM, Abanto C, Arauz A, Shi H, Tang G, Zhu S, She X, Liu L, Sakamoto Y, You S, Han Q, Crutzen B, Cheung E, Li Y, Wang X, Chen C, Liu F, Zhao Y, Li H, Liu Y, Jiang Y, Chen L, Wu B, Liu M, Xu J, You C, Anderson CS; INTERACT3 Investigators. The third Intensive Care Bundle with Blood Pressure Reduction in Acute Cerebral Haemorrhage Trial (INTERACT3): an international, stepped wedge cluster randomised controlled trial. Lancet. 2023 Jul 1;402(10395):27-40. doi: 10.1016/S0140-6736(23)00806-1. Epub 2023 May 25.
- Kalra LP, Khatter H, Ramanathan S, Sapehia S, Devi K, Kaliyaperumal A, Bal D, Sebastian I, Kakarla R, Singhania A, Rathore S, Klinsing S, Pandian JD, Foerch C. Serum GFAP for stroke diagnosis in regions with limited access to brain imaging (BE FAST India). Eur Stroke J. 2021 Jun;6(2):176-184. doi: 10.1177/23969873211010069. Epub 2021 May 11.
- Berkowitz AL. Managing acute stroke in low-resource settings. Bull World Health Organ. 2016 Jul 1;94(7):554-6. doi: 10.2471/BLT.15.162610. Epub 2016 Jun 2. No abstract available.
- Abraham SV, Joy A, Sahu AK, Ravindra P, Dhar S, Teja R, Krishnan SV, Liu R, Rudd AG, Ford GA. Barriers to Effective Prehospital and Hyperacute Stroke Care in India: A Physician Perspective. J Emerg Trauma Shock. 2024 Jul-Sep;17(3):129-135. doi: 10.4103/jets.jets_156_23. Epub 2024 Aug 30.
- Palaniswami M, Yan B. Mechanical Thrombectomy Is Now the Gold Standard for Acute Ischemic Stroke: Implications for Routine Clinical Practice. Interv Neurol. 2015 Oct;4(1-2):18-29. doi: 10.1159/000438774. Epub 2015 Sep 18.
- Ren C, Kobeissy F, Alawieh A, Li N, Li N, Zibara K, Zoltewicz S, Guingab-Cagmat J, Larner SF, Ding Y, Hayes RL, Ji X, Mondello S. Assessment of Serum UCH-L1 and GFAP in Acute Stroke Patients. Sci Rep. 2016 Apr 14;6:24588. doi: 10.1038/srep24588.
- Ramos-Pachon A, Lopez-Cancio E, Bustamante A, Perez de la Ossa N, Millan M, Hernandez-Perez M, Garcia-Berrocoso T, Cardona P, Rubiera M, Serena J, Ustrell X, Garces M, Terceno M, Davalos A, Montaner J. D-Dimer as Predictor of Large Vessel Occlusion in Acute Ischemic Stroke. Stroke. 2021 Mar;52(3):852-858. doi: 10.1161/STROKEAHA.120.031657. Epub 2021 Feb 10.
- Gaude E, Murphy D, Gerstl JVE, Kappel AD, Dmytriw AA, Nawabi NLA, Izzy S, Guardia REA, Vicenty-Padilla JC, Gropen T, Patel NJ, Liebeskind DS, Siddiqui AH, See AP, Aziz-Sultan MA, Bernstock JD. Detection of GFAP and D-Dimer in a Point-of-Care Test for Large Vessel Occlusion Ischemic Stroke. Stroke Vasc Interv Neurol. 2025 Jan 11;5(2):e001559. doi: 10.1161/SVIN.124.001559. eCollection 2025 Mar.
Fechas de registro del estudio
Fechas importantes del estudio
Inicio del estudio (Estimado)
Finalización primaria (Estimado)
Finalización del estudio (Estimado)
Fechas de registro del estudio
Enviado por primera vez
Primero enviado que cumplió con los criterios de control de calidad
Publicado por primera vez (Actual)
Actualizaciones de registros de estudio
Última actualización publicada (Actual)
Última actualización enviada que cumplió con los criterios de control de calidad
Última verificación
Más información
Términos relacionados con este estudio
Palabras clave
Términos MeSH relevantes adicionales
- Trastornos cerebrovasculares
- Enfermedades Cerebrales
- Enfermedades del Sistema Nervioso Central
- Enfermedades del Sistema Nervioso
- Enfermedades Vasculares
- Enfermedades cardiovasculares
- Procesos Patológicos
- Hemorragia
- Hemorragias intracraneales
- Condiciones Patológicas, Signos y Síntomas
- Accidente cerebrovascular isquémico
- Carrera
- Hemorragia cerebral
Otros números de identificación del estudio
- PREDICT INDIA-EMS
Plan de datos de participantes individuales (IPD)
¿Planea compartir datos de participantes individuales (IPD)?
Descripción del plan IPD
The study protocol does not currently specify a plan for sharing individual participant data (IPD) with other researchers. Any future IPD sharing will be considered in accordance with applicable ethical, regulatory, and data-protection requirements.
Información sobre medicamentos y dispositivos, documentos del estudio
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Estudia un producto de dispositivo regulado por la FDA de EE. UU.
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