Helsinki Ultra-acute Stroke Biomarker Study

Acute Stroke Clinical Trial

Official title:

Helsinki Ultra-acute Stroke Biomarker Study

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT02145663
• Other study ID #: HUSBS2013
• Secondary ID: MNEURT ISCHEMIC
• Status: Completed
• Phase: N/A
• First received: May 2, 2014
• Last updated: March 31, 2016
• Start date: May 2013

Study information

• Verified date: March 2016
• Source: Helsinki University Central Hospital
• Contact: n/a
• Is FDA regulated: No
• Health authority: Finland: Ethics Committee
• Study type: Observational

Clinical Trial 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).

Recruitment information / eligibility

• Status: Completed
• Enrollment: 1046
• Est. primary completion date: February 2016
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 18 Years and older

Eligibility

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

Observational Model: Case-Only, Time Perspective: Prospective

Related Conditions & MeSH terms

• Acute Stroke
• Stroke

Locations

Country	Name	City	State
Finland	Helsinki University Central Hospital	Helsinki	Uusimaa

Sponsors (2)

Lead Sponsor	Collaborator
Helsinki University Central Hospital	HUS area Prehospital Emergency Service

Country where clinical trial is conducted

Finland, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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	No
Primary	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	No
Primary	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	No
Primary	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	No

External Links

•   Group internet page