Helsinki Ultra-acute Stroke Biomarker Study

Completed

Phase N/A Results N/A

Trial Description

The aim of this study is to establish diagnostic and predictive biomarkers for patients with suspected acute stroke, that are transported by EMS as candidates for thrombolytic treatment. The study focuses on the ultra acute phase, <4.5 hours from symptom onset, including the prehospital setting. Analyses will include known biomarkers (e.g. GFAP, NR2 peptide) and a discovery phase for novel markers. Patient outcome will be evaluated at 3 month using the modified Rankin Scale (mRS).

Conditions

Trial Design

  • Observation: Case-Only
  • Perspective: Prospective
  • Sampling: Probability Sample

Trial Population

Patients with suspected acute stroke, being transported by emergency medical services (EMS) to a tertiary hospital stroke center, as candidates for thrombolytic treatment of acute ischemic stroke.

Outcomes

Type Measure Time Frame Safety Issue
Primary Diagnostic accuracy of biomarkers for identifying ischemic stroke, transient ischemic attack, intracerebral hemorrhage and stroke mimics. 90 days +/- 5 days No
Primary Predictive accuracy of biomarkers for identifying patients not responding to thrombolytic treatment. 90 days +/- 5 days No
Primary Predictive accuracy of biomarkers for identifying patients facing hemorrhagic complications of thrombolytic treatment 90 days +/- 5 days No
Primary Predictive accuracy of biomarkers for predicting outcome 90 days +/- 5 days No

Biospecimen Retention:Samples Without DNA - Human Serum and Plasma

Sponsors