Helsinki Ultra-acute Stroke Biomarker Study

Completed

• Conditions: Acute Stroke

• Registration Number: NCT02145663
• Lead Sponsor: Helsinki University Central Hospital

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).

Detailed Description

Not available

Study Timeline

• Study Start: 2013-05
• Study First Submitted: 2014-05-02
• Study First Submitted QC: 2014-05-20
• Study First Posted: 2014-05-23
• Primary Completion: 2016-02
• Status Verified: 2016-03
• Last Update Submitted: 2016-03-31
• Last Update Posted: 2016-04-01

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 1046

Inclusion Criteria

• Acute stroke suspected by EMS personnel
• Transport to tertiary hospital as possible candidate for thrombolytic treatment of ischemic stroke
• Age ≥18
• Successful prehospital blood sampling by EMS personnel

Exclusion Criteria

• Unsuccessful prehospital blood sampling by EMS personnel

Study & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
Diagnostic accuracy of biomarkers for identifying ischemic stroke, transient ischemic attack, intracerebral hemorrhage and stroke mimics.	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.	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	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	90 days +/- 5 days	Metrics: Receiver operating characteristic curve analysis, sensitivity, specificity, positive predictive value, negative predictive value

Trial Locations

Locations (1)

Helsinki University Central Hospital; 🇫🇮 Helsinki, Uusimaa, Finland