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Completed

NCT Number: NCT02145663

Helsinki Ultra-acute Stroke Biomarker Study

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).

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Key information

Conditions

Acute Stroke Brain Diseases Cardiovascular Diseases Central Nervous System Diseases Cerebrovascular Disorders Nervous System Diseases Stroke Vascular Diseases

Age range

18 year and older

Sex eligibility

All sexes

Study type

Observational

Primary location

Helsinki University Central Hospital

Helsinki, Uusimaa, 00290, Finland

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Primary outcomes

  1. 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

  2. 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

  3. 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

  4. 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

Sponsors and collaborators

Lead sponsor

Helsinki University Central Hospital

Other

Collaborators

  • HUS area Prehospital Emergency Service

Registry information

Important dates

Study start
2013
Primary completion
2016
First posted
May 23, 2014
Registry last updated
Apr 1, 2016

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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