Helsinki Ultra-acute Stroke Biomarker Study

Status

Completed

Phases

Unknown

Study type

Observational

Source

ClinicalTrials.gov

Registry ID

NCT02145663

Enrollment

1046

Registered

2014-05-23

Start date

2013-05-31

Completion date

Unknown

Last updated

2016-04-01

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Acute Stroke

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).

Interventions

None listed

Study design

Observational model

CASE_ONLY

Time perspective

PROSPECTIVE

Eligibility

Sex/Gender

ALL

Age

18 Years to No maximum

Healthy volunteers

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

Design outcomes

Primary

Measure	Time frame	Description
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

Countries

Finland

Outcome results