Acute StrokeNCT02145663
Helsinki Ultra-acute Stroke Biomarker Study
An observational study of Acute Stroke, run by Helsinki University Central Hospital at 1 site in Finland.
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. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Acute Stroke
- How many people
- 1,046 participants
- Where
- 1 siteFinland
- Study dates
- May 2013to Feb 2016
- Phase
- Observational
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
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.
Who may be able to join
- 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
Who cannot join
- Unsuccessful prehospital blood sampling by EMS personnel
Trial locations and contacts
1 site in 1 country.
About this 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).
- Conditions
- Acute Stroke
- Medical subject headings
- Stroke
What is being measured
The primary outcome is the main question the study is designed to answer.
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
Measured: 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
Measured: 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
Measured: 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
Measured: 90 days +/- 5 days
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted23 May 2014 (estimated)
- Study startMay 2013
- Primary completionFeb 2016
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Acute StrokeStudies of the same condition, open and under way.
- More trials run by Helsinki University Central HospitalThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Case only
- Time perspective
- Prospective
- Enrolment
- 1,046 participants (actual)
Sponsor and investigators
- Lead sponsor
- Helsinki University Central Hospital
- Sponsor type
- University, hospital or other
- Collaborators
- HUS area Prehospital Emergency Service
- Responsible party
- Principal investigator, Perttu Lindsberg, Helsinki University Central Hospital
- Investigators
- Perttu Lindsberg, MD, PhD, Principal investigator, Helsinki University Central Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02145663
- Sponsor's protocol ID
- HUSBS2013
- Other IDs
- MNEURT ISCHEMIC STROKE 813
- Status last verified
- Mar 2016
- First submitted
- 2 May 2014
- Last updated
- 1 Apr 2016
- Results posted
- No
Publications
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.
PubMed 30758276
Study at a glance
From the registry record, last updated by the sponsor on 1 Apr 2016. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Helsinki Ultra-acute Stroke Biomarker Study
- ClinicalTrials.gov ID
- NCT02145663
- Acronym / sponsor ID
- HUSBS2013
- Conditions
- Acute Stroke
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 1,046 participants (actual)
- Lead sponsor
- Helsinki University Central HospitalUniversity, hospital or other
- Collaborators
- HUS area Prehospital Emergency Service
- Study start
- May 2013
- Primary completion
- Feb 2016 (actual)
- First posted
- 23 May 2014 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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 design
- Observational model
- Case only
- Time perspective
- Prospective
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- 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.
Key inclusion criteria (4 listed)
- 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
Key exclusion criteria (1 listed)
- Unsuccessful prehospital blood sampling by EMS personnel
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Primary outcome
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
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
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
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
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 1 Apr 2016.
- Derived from this study: PubMed 30758276Mattila 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.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Perttu Lindsberg, MD, PhD principal investigator
Helsinki University Central Hospital
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Acute Stroke, run by Helsinki University Central Hospital at 1 site in Finland.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 4 inclusion and 1 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 1 Apr 2016. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Finland. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Diagnostic accuracy of biomarkers for identifying ischemic stroke, transient ischemic attack, intracerebral hemorrhage and stroke mimics. (time frame: 90 days +/- 5 days). The study lists 4 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT02145663, which also lists 1 linked publication.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 1 Apr 2016.