Helsinki Ultra-acute Stroke Biomarker Study
Overview
- Phase
- Not Applicable
- Intervention
- Not specified
- Conditions
- Acute Stroke
- Sponsor
- Helsinki University Central Hospital
- Enrollment
- 1046
- Locations
- 1
- Primary Endpoint
- Diagnostic accuracy of biomarkers for identifying ischemic stroke, transient ischemic attack, intracerebral hemorrhage and stroke mimics.
- Status
- Completed
- Last Updated
- 10 years ago
Overview
Brief Summary
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).
Investigators
Perttu Lindsberg
Professor
Helsinki University Central Hospital
Eligibility Criteria
Inclusion Criteria
- •Acute stroke suspected by EMS personnel
- •Transport to tertiary hospital as possible candidate for thrombolytic treatment of ischemic stroke
- •Successful prehospital blood sampling by EMS personnel
Exclusion Criteria
- •Unsuccessful prehospital blood sampling by EMS personnel
Outcomes
Primary Outcomes
Diagnostic accuracy of biomarkers for identifying ischemic stroke, transient ischemic attack, intracerebral hemorrhage and stroke mimics.
Time Frame: 90 days +/- 5 days
Metrics: Receiver operating characteristic curve analysis, sensitivity, specificity, positive predictive value, negative predictive value
Predictive accuracy of biomarkers for identifying patients not responding to thrombolytic treatment.
Time Frame: 90 days +/- 5 days
Metrics: Receiver operating characteristic curve analysis, sensitivity, specificity, positive predictive value, negative predictive value
Predictive accuracy of biomarkers for identifying patients facing hemorrhagic complications of thrombolytic treatment
Time Frame: 90 days +/- 5 days
Metrics: Receiver operating characteristic curve analysis, sensitivity, specificity, positive predictive value, negative predictive value
Predictive accuracy of biomarkers for predicting outcome
Time Frame: 90 days +/- 5 days
Metrics: Receiver operating characteristic curve analysis, sensitivity, specificity, positive predictive value, negative predictive value