NCT04292600: TIME

Testing of Identification Markers for Stroke

Completed Last updated 3 April 2023

What this trial tests

trial testing POCKiT diagnostics' algorithm for LVO detection in Stroke, Ischemic in 383 participants. Completed in 31 January 2023.

Timeline

1 May 2021

Primary endpoint
31 August 2022

31 January 2023

Quick facts

Lead sponsor	POCKiT diagnostics Ltd
Status	Completed
Study type	OBSERVATIONAL
Enrollment	383
Start date	1 May 2021
Primary completion	31 August 2022
Estimated completion	31 January 2023
Sites	3 locations across United States

Drugs / interventions tested

• POCKiT diagnostics' algorithm for LVO detection

Conditions studied

• Stroke, Ischemic — all drugs for Stroke, Ischemic →
• Infarction, Middle Cerebral Artery — all drugs for Infarction, Middle Cerebral Artery →
• Infarction, Anterior Circulation, Brain — all drugs for Infarction, Anterior Circulation, Brain →

Sponsor

POCKiT diagnostics Ltd

Who can join

18 and older, any sex, with Stroke, Ischemic or Infarction, Middle Cerebral Artery. Patients with the condition only — healthy volunteers not accepted.

Sponsor's own description

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.

Publications & conference data

2 peer-reviewed publications reference this trial (live from Europe PMC):

1. Prospective Validation of Glial Fibrillary Acidic Protein, d-Dimer, and Clinical Scales for Acute Large-Vessel Occlusion Ischemic Stroke Detection.
   Durrani Y, Gerstl JVE, Murphy D, Harris A, et al · · 2024 · cited 1× · PMID 41585381 · DOI 10.1161/svin.123.001304
2. Prehospital Detection of Large Vessel Occlusion and Intracerebral Hemorrhage Using a Dual-Biomarker Point-of-Care Test.
   Ghosh A, Nawabi NLA, Alcedo D, Alcedo Guardia RE, et al · · 2026 · PMID 42088320 · DOI 10.1161/svin.125.002170