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Testing of Identification Markers for Stroke

NCT04292600 · Status: COMPLETED · Type: OBSERVATIONAL · Enrollment: 383

Last updated 2023-04-03

No results posted yet for this study

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

Interventions

DIAGNOSTIC_TEST

POCKiT diagnostics' algorithm for LVO detection

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

Sponsors & Collaborators

  • University of Alabama at Birmingham

    collaborator OTHER

  • University of Mississippi Medical Center

    collaborator OTHER

  • Bay Area Consulting Telemedicine

    collaborator UNKNOWN

  • POCKiT diagnostics Ltd

    lead INDUSTRY

Principal Investigators

  • Shashank Shekar, MD · University of Mississippi Medical Center

  • Toby Gropen, MD · University of Alabama in Birmingham Comprehensive Stroke Center

  • Allauddin Khan, MD · BAC Telemed (Brandon Regional Hospital)

Eligibility

Min Age
18 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2021-05-01
Primary Completion
2022-08-31
Completion
2023-01-31

Countries

  • United States

Study Locations

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Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT04292600 on ClinicalTrials.gov