[{"data":1,"prerenderedAt":-1},["ShallowReactive",2],{"health-study-detail:100657806":3},{"organization":4,"outcomesModule":7,"designInfo":42,"detailedDescription":50,"studyPopulation":41,"armGroups":51,"interventions":64,"overallOfficials":74,"centralContacts":80,"locations":88,"responsibleParty":119,"collaborators":121,"id":125,"slug":126,"hasResults":127,"nctId":128,"briefTitle":129,"officialTitle":130,"acronym":41,"eligibilityCriteria":131,"healthyVolunteers":127,"sex":132,"minAge":133,"maxAge":134,"enrollmentInfo":135,"targetDuration":41,"studyType":138,"phases":139,"briefSummary":141,"conditions":142,"keywords":144,"overallStatus":156,"whyStopped":41,"lastUpdateSubmitDate":157,"lastUpdatePostDateStruct":158,"startDateStruct":161,"completionDateStruct":163,"leadSponsor":165,"locationsCount":166},{"fullName":5,"class":6},"Christian Medical College and Hospital, Ludhiana, India","OTHER",{"primaryOutcomes":8,"secondaryOutcomes":19,"otherOutcomes":41},[9,13,16],{"measure":10,"description":11,"timeFrame":12},"PREDICT assessment model","(Phase 1) Sensitivity and Specificity and PREDICT assessment model. Accurate identification of ICH \\>90% using PREDICT model.","30 mins",{"measure":14,"description":15,"timeFrame":12},"Time for Device Application by Paramedics","(Phase 1) The time taken by paramedics\u002F ED personnel to apply the CEREBO NIRS device and obtain GFAP\u002FD Dimer results. Lesser time indicates good outcome.",{"measure":17,"description":18,"timeFrame":12},"Treatment initiation","(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.",[20,24,27,30,34,38],{"measure":21,"description":22,"timeFrame":23},"Inter-Center Variability","(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",{"measure":25,"description":26,"timeFrame":23},"Correlation with Gold Standard","(Phase 1) Agreement between the PREDICT assessment model and the CT head scan diagnosis (the gold standard). More correlation indicates better outcome.",{"measure":28,"description":29,"timeFrame":23},"Safety Metrics","Phase 1 Documentation of adverse events related to the testing procedure. Fewer events indicate a better outcome.",{"measure":31,"description":32,"timeFrame":33},"modified Rankin Scale","Phase 2 Functional outcome at 90 days Lower score (0-3) indicates good outcome","90 days",{"measure":35,"description":36,"timeFrame":37},"In-hospital mortality","Phase 2 In-hospital mortality. Lesser mortality indicates better outcome","7 days",{"measure":39,"description":40,"timeFrame":33},"Adverse events","Phase 2 Incidence of adverse events (e.g., symptomatic ICH). Lesser events indicate better outcome.",null,{"allocation":43,"interventionModel":44,"interventionModelDescription":45,"primaryPurpose":46,"observationalModel":41,"timePerspective":41,"maskingInfo":47},"RANDOMIZED","PARALLEL","Phase I Suspected stroke patients will undergo CEREBRO NIRS assessment during ambulance transport or upon arrival in the CMC, Ludhiana emergency department. CT imaging will serve as the gold standard reference.\n\nPhase II Ambulance services within the catchment areas of Christian Medical College (CMC), Ludhiana and JIPMER, Puducherry will be randomized into two parallel groups: an intervention group using the PREDICT Assessment Model (GFAP\u002FD-Dimer point-of-care testing plus CEREBO Near-Infrared Spectroscopy) and a control group receiving standard prehospital stroke care and transport for CT-based diagnosis. Randomization will occur centrally at the command center using a computer-generated randomization sequence with allocation concealment.","DIAGNOSTIC",{"masking":48,"maskingDescription":49,"whoMasked":41},"NONE","This is an open-label diagnostic medical device trial. Participants, ambulance personnel, investigators, and treating clinicians will be aware of the assigned intervention because the GFAP\u002FD-Dimer point-of-care test and CEREBO-NIRS device are used during prehospital assessment.","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\u002FD-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.\n\nThe 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\u002FD-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.\n\nPhase 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\u002FD-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.\n\nThe primary objective of the study is to validate the diagnostic accuracy and feasibility of the combined GFAP\u002FD-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.",[52,58],{"label":53,"type":54,"description":55,"interventionNames":56},"PREDICT Assessment Model","EXPERIMENTAL","Ambulances in the intervention group will use the GFAP\u002FD-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.",[57],"Diagnostic Test: GFAP\u002FD-Dimer Point-of-Care Testing & CEREBO Near-Infrared Spectroscopy (NIRS)",{"label":59,"type":60,"description":61,"interventionNames":62},"Standard Care","ACTIVE_COMPARATOR","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.",[63],"Diagnostic Test: CT Head",[65,70],{"type":66,"name":67,"description":68,"armGroupLabels":69,"otherNames":41},"DIAGNOSTIC_TEST","GFAP\u002FD-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\u002FD-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.",[53],{"type":66,"name":71,"description":72,"armGroupLabels":73,"otherNames":41},"CT Head","Standard care CT head imaging",[59],[75,78],{"name":76,"affiliation":5,"role":77},"Dr Jeyaraj D Pandian, MD DM","PRINCIPAL_INVESTIGATOR",{"name":79,"affiliation":5,"role":77},"Dr Ivy A Sebastian",[81,85],{"name":79,"role":82,"phone":83,"phoneExt":41,"email":84},"CONTACT","09592588138","ivy29cmc@gmail.com",{"name":76,"role":82,"phone":86,"phoneExt":41,"email":87},"9915784750","jeyarajpandian@hotmail.com",[89,106],{"facility":90,"status":41,"city":91,"state":91,"zip":92,"country":93,"countryCode":94,"cosmosGeoPoint":95,"geoPoint":100,"contacts":101},"Jawaharlal Institute of Postgraduate Medical Education and Research Puducherry JIPMER","Puducherry","605006","India","IN",{"type":96,"coordinates":97},"Point",[98,99],79.82979,11.93381,{"lat":99,"lon":98},[102],{"name":103,"role":82,"phone":104,"phoneExt":41,"email":105},"Dr Manu Ayyan","9846556133","manuayyan@hotmail.com",{"facility":107,"status":41,"city":108,"state":109,"zip":110,"country":93,"countryCode":94,"cosmosGeoPoint":111,"geoPoint":115,"contacts":116},"Christian Medical College and Hospital","Ludhiana","Punjab","141008",{"type":96,"coordinates":112},[113,114],75.85379,30.91204,{"lat":114,"lon":113},[117],{"name":79,"role":82,"phone":118,"phoneExt":41,"email":84},"9999464986",{"type":120,"investigatorFullName":41,"investigatorTitle":41,"investigatorAffiliation":41,"oldNameTitle":41,"oldOrganization":41},"SPONSOR",[122],{"name":123,"class":124},"Indian Council of Medical Research","OTHER_GOV","100657806","glial-fibrillary-acidic-protein-testing-and-handheld-near-infrared-spectroscopy-technology-cerebo-in-india-100657806",false,"NCT07844109","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.","Phase 1\n\nInclusion criteria\n\n* Adult patients of any gender ≥18 years with clinically suspected stroke\n* Transported by ambulance or presenting directly to ED of participating hospitals\n* Time from symptom onset\u002F Lost known well time (within 24 hours)\n* Consent provided by patient\u002F next of kin\n\nExclusion criteria:\n\n* Patients with known pre-existing neurological conditions that may confound diagnosis (Concurrent traumatic brain injury, recent TBI in last 3months, IS\u002FICH in last 3 months, Diagnosis of brain tumour\u002FSOL)\n* Patients with known medical condition with estimated life expectancy ≤ 3 months\n* Those refusing consent\n\nPhase 2\n\nInclusion criteria:\n\n* Adult patients of any gender ≥18 years with clinically suspected stroke\n* Transported by ambulance to ED of participating hospitals\n* Time from symptom onset\u002F Last well known time (≤ 24 hours)\n* NIHSS ≥ 5\n* Consent provided by patient\u002F next of kin\n\nExclusion criteria:\n\n* Patients with known pre-existing neurological conditions that may confound diagnosis (Concurrent traumatic brain injury, recent TBI in last 3months, IS\u002F ICH in last 3 months, Diagnosis of brain tumour\u002F SOL)\n* Patients with known medical condition with estimated life expectancy ≤ 3 months\n* Those refusing consent","ALL","18 Years","99 Years",{"count":136,"type":137},232,"ESTIMATED","INTERVENTIONAL",[140],"NA","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\u002FD-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.\n\nPHASE I: Validation of a diagnostic accuracy and feasbility of PREDICT assessment model (a combined approach using GFAP\u002F D-dimer POC lateral flow assay plus CEREBO-NIRS technology).\n\nStudy Design: Prospective, Multicenter, Validation and Feasibility Study.\n\nPHASE II: Pilot RCT to assess integration of the PREDICT assessment model into pre-hospital pathways.\n\nStudy Design: Pilot Randomized Controlled Trial (RCT) (Year 3-5)",[143],"Stroke",[145,146,147,148,149,150,151,152,53,153,154,155],"Acute stroke","Ischemic stroke","Intracerebral hemorrhage","Prehospital stroke triage","GFAP","D-Dimer","CEREBO","Near-Infrared Spectroscopy","Point-of-Care Testing","Stroke classification","Stroke diagnosis","NOT_YET_RECRUITING","2026-09-21",{"date":159,"type":160},"2026-09-28","ACTUAL",{"date":162,"type":137},"2027-09-01",{"date":164,"type":137},"2031-08-30",{"name":5,"class":6},2]