Testing of Identification Markers for Stroke

Completed

Conditions studied: Stroke, Ischemic, Infarction, Middle Cerebral Artery, Infarction, Anterior Circulation, Brain

In brief

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.

Key facts

Study ID

NCT04292600

Run by

POCKiT diagnostics Ltd

People needed

383

Starts

2021-05-01

Expected to finish

2023-01-31

Last updated by the study team

2023-04-03

Who can join

Age: 18 and older. Sex: any. Healthy volunteers: not accepted.

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)

Where it is running

• University of Alabama in Birmingham Comprehensive Stroke Center — Birmingham, Alabama, United States
• BAC Telemed - Brandon Regional Hospital — Brandon, Florida, United States
• University of Mississippi Medical Center — Jackson, Mississippi, United States

Full record on ClinicalTrials.gov

Trial information comes from ClinicalTrials.gov and is refreshed daily. TrialsForMe does not provide medical care and does not run the studies it lists.