Helsinki Ultra-acute Stroke Biomarker Study

March 31, 2016 updated by: Perttu Lindsberg, Helsinki University Central Hospital
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).

Study Overview

Status

Completed

Conditions

Study Type

Observational

Enrollment (Actual)

1046

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • Finland
    • Uusimaa
      • Helsinki, Uusimaa, Finland, 00290
        • Helsinki University Central Hospital

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years and older (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Sampling Method

Probability Sample

Study Population

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.

Description

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 Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Observational Models: Case-Only
  • Time Perspectives: Prospective

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
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
90 days +/- 5 days
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
90 days +/- 5 days
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
90 days +/- 5 days
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
90 days +/- 5 days

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Helsinki University Central Hospital

Collaborators

HUS area Prehospital Emergency Service

Investigators

  • Principal Investigator: Perttu Lindsberg, MD, PhD, Helsinki University Central Hospital

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Helpful Links

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

May 1, 2013

Primary Completion (Actual)

February 1, 2016

Study Registration Dates

First Submitted

May 2, 2014

First Submitted That Met QC Criteria

May 20, 2014

First Posted (Estimate)

May 23, 2014

Study Record Updates

Last Update Posted (Estimate)

April 1, 2016

Last Update Submitted That Met QC Criteria

March 31, 2016

Last Verified

March 1, 2016

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

  • HUSBS2013
  • MNEURT ISCHEMIC STROKE 813 (Other Identifier: HUCH)

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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