Helsinki Ultra-acute Stroke Biomarker Study
2 other identifiers
observational
1,046
1 country
1
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).
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P75+ for all trials
1 active site
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
Study Start
First participant enrolled
May 1, 2013
CompletedFirst Submitted
Initial submission to the registry
May 2, 2014
CompletedFirst Posted
Study publicly available on registry
May 23, 2014
CompletedPrimary Completion
Last participant's last visit for primary outcome
February 1, 2016
CompletedApril 1, 2016
March 1, 2016
2.8 years
May 2, 2014
March 31, 2016
Conditions
Outcome Measures
Primary Outcomes (4)
Diagnostic accuracy of biomarkers for identifying ischemic stroke, transient ischemic attack, intracerebral hemorrhage and stroke mimics.
Metrics: Receiver operating characteristic curve analysis, sensitivity, specificity, positive predictive value, negative predictive value
90 days +/- 5 days
Predictive accuracy of biomarkers for identifying patients not responding to thrombolytic treatment.
Metrics: Receiver operating characteristic curve analysis, sensitivity, specificity, positive predictive value, negative predictive value
90 days +/- 5 days
Predictive accuracy of biomarkers for identifying patients facing hemorrhagic complications of thrombolytic treatment
Metrics: Receiver operating characteristic curve analysis, sensitivity, specificity, positive predictive value, negative predictive value
90 days +/- 5 days
Predictive accuracy of biomarkers for predicting outcome
Metrics: Receiver operating characteristic curve analysis, sensitivity, specificity, positive predictive value, negative predictive value
90 days +/- 5 days
Eligibility Criteria
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.
You may qualify if:
- 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
You may not qualify if:
- Unsuccessful prehospital blood sampling by EMS personnel
Contact the study team to confirm eligibility.
Sponsors & Collaborators
Study Sites (1)
Helsinki University Central Hospital
Helsinki, Uusimaa, 00290, Finland
Related Publications (1)
Mattila OS, Puolakka T, Ritvonen J, Pihlasviita S, Harve H, Alanen A, Sibolt G, Curtze S, Strbian D, Pystynen M, Tatlisumak T, Kuisma M, Lindsberg PJ. Targets for improving dispatcher identification of acute stroke. Int J Stroke. 2019 Jun;14(4):409-416. doi: 10.1177/1747493019830315. Epub 2019 Feb 13.
PMID: 30758276DERIVED
Biospecimen
Human Serum and Plasma
MeSH Terms
Conditions
Condition Hierarchy (Ancestors)
Study Officials
- PRINCIPAL INVESTIGATOR
Perttu Lindsberg, MD, PhD
Helsinki University Central Hospital
Study Design
- Study Type
- observational
- Observational Model
- CASE ONLY
- Time Perspective
- PROSPECTIVE
- Sponsor Type
- OTHER
- Responsible Party
- PRINCIPAL INVESTIGATOR
- PI Title
- Professor
Study Record Dates
First Submitted
May 2, 2014
First Posted
May 23, 2014
Study Start
May 1, 2013
Primary Completion
February 1, 2016
Last Updated
April 1, 2016
Record last verified: 2016-03