Testing of Identification Markers for Stroke

NCT04292600 | Completed

• 1 other identifier: POCKiT
• Study Type: observational
• Target: 383
• Locations: 1 country
• Sites: 3

Brief Summary

Stroke is the third leading cause of death and the first cause of physical disability and dementia worldwide. Ischemic stroke caused by large vessel occlusion (LVO) is responsible for the vast majority of deaths and disabilities. A very effective and safe treatment, called mechanical thrombectomy (MT) is available for LVO patients. Nevertheless, no blood biomarkers able to identify LVO patients rapidly and to direct them to CT angiography and thrombectomy currently exist. The TIME study is an observational prospective cohort study. All Patients referred to the emergency department or stroke unit with a suspected stroke as identified by paramedics, nurses or clinicians will be enrolled in the study. A panel of blood biomarkers will be analysed retrospectively via standard laboratory assays. The main outcome of the TIME study will be the evaluation of the clinical diagnostic performance of a panel of blood biomarkers, in conjunction with clinical data, for the identification of large vessel occlusion ischemic stroke subtype. This study will allow the identification and evaluation of a final panel of biomarkers and will prompt the development of a test for LVO stroke diagnosis.

Conditions

Stroke, Ischemic; Infarction, Middle Cerebral Artery; Infarction, Anterior Circulation, Brain

Keywords

large vessel occlusion strokes

Outcome Measures

Primary Outcomes (1)

• Diagnostic accuracy measures for LVO detection vs non-LVO stroke activations

  Accuracy of pre-defined algorithm thresholds for LVO identification from the population of all suspected strokes (Ischemics non-LVO, Hemorrhagic, Mimics, TIAs)

  1 year

Secondary Outcomes (1)

• Optimisation of the cut-off points of the diagnostic algorithm for LVO detection

  1 year

Study Arms (1)

BRH

Cohort recruited at Brandon Regional Hospital by Bay Area Consulting Telemedicine

Diagnostic Test: POCKiT diagnostics' algorithm for LVO detection

Interventions

POCKiT diagnostics' algorithm for LVO detection DIAGNOSTIC_TEST

Measurement of blood biomarkers and integration within Pockit diagnostics' algorithm for LVO detection

BRH

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)
• Sampling Method: Probability Sample

Study Population

Patients admitted to the ambulance and ED with suspected stroke will be recruited in the study. Patient population is expected to be composed of \~50% ischemic strokes (of which \~30-40% could have LVOs), \~40% stroke mimics, and \~10% haemorrhagic strokes.

You may qualify if:

• Referred to the ambulance or emergency department for suspected stroke.
• Time from stroke onset \< 18 hours

You may not qualify if:

• Received thrombolytic therapy (e.g. tPA, Alteplase) before collection of blood;
• (Anticipated) inability to provide a blood sample;
• Time from stroke onset \> 18 hours.
• At time of consent participating in a Clinical Trial Investigational Medicinal Product (CTIMP)

Sponsors & Collaborators

• POCKiT diagnostics Ltd: lead
• University of Alabama at Birmingham: collaborator
• University of Mississippi Medical Center: collaborator
• Bay Area Consulting Telemedicine: collaborator

Study Sites (3)

University of Alabama in Birmingham Comprehensive Stroke Center

Birmingham, Alabama, 35294, United States

Location

BAC Telemed - Brandon Regional Hospital

Brandon, Florida, 33511, United States

Location

University of Mississippi Medical Center

Jackson, Mississippi, 39216, United States

Location

Related Publications (4)

• 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.

  PMID: 29250029 BACKGROUND

• Nogueira RG, Jadhav AP, Haussen DC, Bonafe A, Budzik RF, Bhuva P, Yavagal DR, Ribo M, Cognard C, Hanel RA, Sila CA, Hassan AE, Millan M, Levy EI, Mitchell P, Chen M, English JD, Shah QA, Silver FL, Pereira VM, Mehta BP, Baxter BW, Abraham MG, Cardona P, Veznedaroglu E, Hellinger FR, Feng L, Kirmani JF, Lopes DK, Jankowitz BT, Frankel MR, Costalat V, Vora NA, Yoo AJ, Malik AM, Furlan AJ, Rubiera M, Aghaebrahim A, Olivot JM, Tekle WG, Shields R, Graves T, Lewis RJ, Smith WS, Liebeskind DS, Saver JL, Jovin TG; DAWN Trial Investigators. Thrombectomy 6 to 24 Hours after Stroke with a Mismatch between Deficit and Infarct. N Engl J Med. 2018 Jan 4;378(1):11-21. doi: 10.1056/NEJMoa1706442. Epub 2017 Nov 11.

  PMID: 29129157 BACKGROUND

• Gropen TI, Boehme A, Martin-Schild S, Albright K, Samai A, Pishanidar S, Janjua N, Brandler ES, Levine SR. Derivation and Validation of the Emergency Medical Stroke Assessment and Comparison of Large Vessel Occlusion Scales. J Stroke Cerebrovasc Dis. 2018 Mar;27(3):806-815. doi: 10.1016/j.jstrokecerebrovasdis.2017.10.018. Epub 2017 Nov 22.

  PMID: 29174289 BACKGROUND

• Durrani 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.

  PMID: 41585381 DERIVED

Biospecimen

Retention: SAMPLES WITHOUT DNA

Plasma and whole blood

MeSH Terms

Conditions

Ischemic Stroke; Infarction, Middle Cerebral Artery; Brain Infarction

Condition Hierarchy (Ancestors)

Stroke; Cerebrovascular Disorders; Brain Diseases; Central Nervous System Diseases; Nervous System Diseases; Vascular Diseases; Cardiovascular Diseases; Cerebral Infarction; Brain Ischemia; Cerebral Arterial Diseases; Intracranial Arterial Diseases; Infarction; Ischemia; Pathologic Processes; Pathological Conditions, Signs and Symptoms; Necrosis

Study Officials

• Shashank Shekar, MD

  University of Mississippi Medical Center

  PRINCIPAL INVESTIGATOR

• Toby Gropen, MD

  University of Alabama in Birmingham Comprehensive Stroke Center

  PRINCIPAL INVESTIGATOR

• Allauddin Khan, MD

  BAC Telemed (Brandon Regional Hospital)

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: PROSPECTIVE
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: February 20, 2020
• First Posted: March 3, 2020
• Study Start: May 1, 2021
• Primary Completion: August 31, 2022
• Study Completion: January 31, 2023
• Last Updated: April 3, 2023

Record last verified: 2023-03

Locations

US (3)