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)
調査の概要
状態
条件
詳細な説明
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.
研究の種類
入学 (推定)
段階
- 適用できない
連絡先と場所
研究連絡先
- 名前：Dr Ivy A Sebastian
- 電話番号：09592588138
- メール：ivy29cmc@gmail.com
研究連絡先のバックアップ
- 名前：Dr Jeyaraj D Pandian, MD DM
- 電話番号：9915784750
- メール：jeyarajpandian@hotmail.com
研究場所
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Puducherry
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Puducherry、Puducherry、インド、605006
- Jawaharlal Institute of Postgraduate Medical Education and Research Puducherry JIPMER
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コンタクト：
- Dr Manu Ayyan
- 電話番号：9846556133
- メール：manuayyan@hotmail.com
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Punjab
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Ludhiana、Punjab、インド、141008
- Christian Medical College and Hospital
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コンタクト：
- Dr Ivy A Sebastian
- 電話番号：9999464986
- メール：ivy29cmc@gmail.com
-
-
参加基準
適格基準
就学可能な年齢
健康ボランティアの受け入れ
受講資格のある性別
説明
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
研究計画
研究はどのように設計されていますか？
デザインの詳細
- 主な目的：診断
- 割り当て：ランダム化
- 介入モデル：並列代入
- マスキング：なし（オープンラベル）
武器と介入
参加者グループ / アーム |
介入・治療 |
|---|---|
|
実験的：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. |
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. |
|
アクティブコンパレータ：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 |
この研究は何を測定していますか？
主要な結果の測定
結果測定 |
メジャーの説明 |
時間枠 |
|---|---|---|
|
PREDICT assessment model
時間枠：30 mins
|
(Phase 1) Sensitivity and Specificity and PREDICT assessment model. Accurate identification of ICH >90% using PREDICT model. |
30 mins
|
|
Time for Device Application by Paramedics
時間枠：30 mins
|
(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
|
|
Treatment initiation
時間枠：30 mins
|
(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
|
二次結果の測定
結果測定 |
メジャーの説明 |
時間枠 |
|---|---|---|
|
Inter-Center Variability
時間枠：2 years
|
(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
時間枠：2 years
|
(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
時間枠：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
時間枠：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
時間枠：7 days
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Phase 2 In-hospital mortality. Lesser mortality indicates better outcome |
7 days
|
|
Adverse events
時間枠：90 days
|
Phase 2 Incidence of adverse events (e.g., symptomatic ICH). Lesser events indicate better outcome. |
90 days
|
協力者と研究者
捜査官
- 主任研究者：Dr Ivy A Sebastian、Christian Medical College and Hospital, Ludhiana, India
- 主任研究者：Dr Jeyaraj D Pandian, MD DM、Christian Medical College and Hospital, Ludhiana, India
出版物と役立つリンク
一般刊行物
- 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.
研究記録日
主要日程の研究
研究開始 (推定)
一次修了 (推定)
研究の完了 (推定)
試験登録日
最初に提出
QC基準を満たした最初の提出物
最初の投稿 (実際)
学習記録の更新
投稿された最後の更新 (実際)
QC基準を満たした最後の更新が送信されました
最終確認日
詳しくは
本研究に関する用語
キーワード
その他の研究ID番号
- PREDICT INDIA-EMS
個々の参加者データ (IPD) の計画
個々の参加者データ (IPD) を共有する予定はありますか?
IPD プランの説明
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.
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