Emergency MedicinewakeupstrokeNCT07453277
Blood-Based Molecular Clock Biomarkers Predict Acute Ischemic Stroke Onset: A Prospective Observational Study
An observational study of Emergency Medicine and Stroke Acute, run by Izmir Katip Celebi University at 1 site in Turkey (Türkiye).
Trial summary
Acute ischemic stroke (AIS) is a major cause of mortality and long-term neurological disability worldwide. The effectiveness of reperfusion therapies such as intravenous thrombolysis and mechanical thrombectomy is highly dependent on the time elapsed since symptom onset. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Emergency Medicine, Stroke Acute
- How many people
- 80 participants
- Where
- 1 siteTurkey (Türkiye)
- Study dates
- 1 Mar 2026to 1 Apr 2027
- Phase
- Observational
- Are there results?
- Not yet: the study is under way
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 acute ischemic stroke whose onset time is unknown or who present with a wake-up stroke. Serum/plasma samples obtained from venous blood samples taken during routine clinical practice in all patients will be analyzed for GFAP, UCH-L1, sNfL, PEBP1, and MMP-9 levels. Patients' demographic data, clinical characteristics, NIHSS scores, and magnetic resonance imaging (MRI) findings (particularly DWI-FLAIR mismatch status) will be recorded from the electronic patient record system. The performance of the multi-compartment molecular panel formed by the obtained biomarker levels in distinguishing the biological time window of acute ischemic stroke (≤4.5 hours vs. >4.5 hours) will be evaluated by comparing it with the imaging-based reference method.
Who may be able to join
- Be 18 years of age or older
- Presence of acute focal neurological deficit
- Presentation within ≤24 hours of the last time the patient was well
Who cannot join
- Intracranial hemorrhage
- Active infection or sepsis
- Major surgery/trauma within the last 14 days
- Active autoimmune disease
- Stroke within the last 3 months
- Immunosuppressive therapy
Trial locations and contacts
1 site in 1 country.
Turkey (Türkiye)1 site
Izmir Katip Çelebi University Ataturk Research and Training Hospital
Izmir, 35220
About this study
Official title: The Role of Blood-Based Molecular Clock Biomarkers in Predicting the Onset Time of Acute Ischemic Stroke: A Prospective Observational Study
Acute ischemic stroke (AIS) is a major cause of mortality and long-term neurological disability worldwide. The effectiveness of reperfusion therapies such as intravenous thrombolysis and mechanical thrombectomy is highly dependent on the time elapsed since symptom onset. However, in approximately 15-25% of patients, the exact onset time cannot be determined because symptoms begin during sleep (wake-up stroke) or the onset is otherwise unclear. This uncertainty often prevents patients from receiving time-dependent reperfusion treatments.
Currently, imaging-based approaches such as diffusion-weighted imaging-fluid attenuated inversion recovery (DWI-FLAIR) mismatch are used to estimate the biological stage of ischemia in patients with unknown onset time. However, advanced imaging techniques may not be available in all centers and interpretation may vary.
Read more
This study aims to evaluate the diagnostic performance of a multi-biomarker panel representing different biological components of ischemic brain injury, including glial, neuronal, axonal, cellular stress, and vascular responses. Blood samples obtained at admission will be analyzed for glial fibrillary acidic protein (GFAP), ubiquitin C-terminal hydrolase L1 (UCH-L1), serum neurofilament light chain (sNfL), phosphatidylethanolamine-binding protein 1 (PEBP1), and matrix metalloproteinase-9 (MMP-9).
The primary objective is to determine whether this biomarker panel can distinguish patients presenting within ≤4.5 hours from those presenting after >4.5 hours of symptom onset. Biomarker findings will be compared with imaging-based reference methods to explore the feasibility of a blood-based "molecular clock" approach for estimating stroke timing in patients with uncertain onset.
Read the detailed description
Acute ischemic stroke (AIS) is one of the leading causes of mortality and long-term neurological disability worldwide. The effectiveness of reperfusion therapies, including intravenous thrombolysis and mechanical thrombectomy, is highly dependent on the time elapsed since symptom onset. Determination of the symptom onset time is therefore a critical component of treatment eligibility. However, a substantial proportion of patients present with stroke symptoms of unknown onset, most commonly because the symptoms develop during sleep (wake-up stroke) or because the exact onset time cannot be reliably established. This uncertainty may prevent eligible patients from receiving time-dependent reperfusion therapies.
Current clinical decision-making in patients with uncertain onset time relies largely on imaging-based approaches that attempt to estimate the biological stage of ischemia. The diffusion-weighted imaging-fluid attenuated inversion recovery (DWI-FLAIR) mismatch concept is the most widely used method and is based on the hypothesis that tissue signal evolution reflects the duration of ischemia. Advanced perfusion imaging techniques have also been incorporated into clinical practice. However, these imaging methods require specialized equipment and expertise, may not be available in all centers, and their interpretation may vary between institutions. Consequently, there is increasing interest in identifying circulating biomarkers that can reflect the biological timing of ischemic injury.
Ischemic brain injury initiates a complex cascade of pathophysiological processes involving astroglial activation, neuronal membrane disruption, axonal injury, inflammatory signaling, cellular stress responses, and vascular dysfunction. These processes evolve dynamically over time and lead to the release of measurable molecular components into the systemic circulation. Biomarkers reflecting different cellular compartments of the neurovascular unit may therefore provide complementary information regarding the temporal evolution of ischemic injury.
Several candidate biomarkers have been identified that represent different biological aspects of this process. Glial fibrillary acidic protein (GFAP) is an astrocyte-specific structural protein that reflects astroglial injury and early glial activation following acute brain damage. Ubiquitin C-terminal hydrolase L1 (UCH-L1) is a neuron-specific cytoplasmic enzyme released after neuronal membrane disruption and has been proposed as an indicator of acute neuronal injury. Serum neurofilament light chain (sNfL) is a structural component of the axonal cytoskeleton and is considered a marker of axonal degeneration and structural neuronal damage. Phosphatidylethanolamine-binding protein 1 (PEBP1), also known as Raf kinase inhibitory protein, is involved in the regulation of cellular signaling pathways and stress responses and may reflect cellular adaptation to ischemic stress. Matrix metalloproteinase-9 (MMP-9) is associated with inflammatory activation, extracellular matrix degradation, and blood-brain barrier dysfunction during the evolution of ischemic brain injury.
The combined evaluation of biomarkers representing multiple biological layers of the neurovascular unit may provide a more comprehensive representation of the temporal dynamics of ischemic injury than single-marker approaches. A multi-biomarker strategy has the potential to capture different phases of the ischemic cascade, including glial activation, neuronal damage, axonal injury, cellular stress response, and vascular dysfunction.
The present study aims to investigate whether a multi-compartment biomarker panel can contribute to the estimation of the biological timing of acute ischemic stroke. By evaluating circulating biomarkers representing different components of the neurovascular unit, the study seeks to explore the feasibility of a blood-based molecular signature that reflects the temporal evolution of ischemic injury.
The findings of this study may contribute to the development of a biologically informed approach for estimating stroke timing and may support clinical decision-making in patients presenting with uncertain symptom onset, particularly in settings where advanced imaging techniques are not readily available.
- Conditions
- Emergency Medicine, Stroke Acute
- Keywords
- molecular clock biomarkers, wake up stroke, acute stroke
- Medical subject headings
- Stroke, Ischemic Stroke
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
| Study group | Role | What they receive |
|---|---|---|
| ACUTE STROKE PRESENTING TO THE EMERGENCY DEPARTMENT-1 | ACUTE STROKE PRESENTING TO THE EMERGENCY DEPARTMENT (WITNESSED STROKE, STROKE WITH KNOWN OCCURRENCE) | |
| ACUTE WAKE UP STROKE PRESENTING TO THE EMERGENCY DEPARTMENT-2 | WAKE UP STROKE (Without Witnesses and Unknown Start Time) |
What is being measured
The primary outcome is the main question the study is designed to answer.
Diagnostic performance of the multi-biomarker panel in identifying the biological time window of acute ischemic stroke (≤4.5 hours vs >4.5 hours from symptom onset)
The primary outcome will be the ability of the combined biomarker panel (GFAP, UCH-L1, sNfL, PEBP1, and MMP-9) measured from admission blood samples to discriminate patients presenting within ≤4.5 hours versus >4.5 hours after symptom onset. Diagnostic performance will be evaluated using receiver operating characteristic (ROC) curve analysis and reported as area under the curve (AUC), sensitivity, specificity, and optimal cut-off values.
Measured: At emergency department admission.
Secondary outcomes (4)
Diagnostic performance of individual biomarkers
The diagnostic accuracy of each biomarker (GFAP, UCH-L1, sNfL, PEBP1, and MMP-9) will be evaluated individually for distinguishing ≤4.5 hours versus >4.5 hours from symptom onset using ROC curve analysis.
Measured: At emergency department admission.
Association between biomarker levels and imaging-based reference methods
Circulating biomarker levels will be compared with imaging findings used to estimate stroke timing (e.g., DWI-FLAIR mismatch or other clinically available imaging parameters) to assess concordance between molecular and imaging-based indicators of ischemic timing.
Measured: Baseline imaging obtained at hospital admission.
Incremental diagnostic value of the combined biomarker model
We will assess multivariable models that include the biomarker panel to see if analyzing the biomarkers together offers better diagnostic accuracy than looking at each biomarker separately.
Measured: At emergency department admission.
Correlation between circulating biomarker levels and infarct volume on diffusion-weighted imaging (DWI)
The relationship between admission biomarker concentrations (GFAP, UCH-L1, sNfL, PEBP1, and MMP-9) and infarct volume measured on diffusion-weighted magnetic resonance imaging (DWI) will be evaluated to explore the association between molecular markers of ischemic injury and the extent of cerebral infarction. Correlation analyses will be performed to determine whether biomarker levels reflect infarct burden.
Measured: Baseline imaging obtained within the initial diagnostic evaluation after hospital admission.
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted5 Mar 2026
- Study start1 Mar 2026
- Primary completion1 Mar 2027 (estimated)
- Study completion1 Apr 2027 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (5)Papers the sponsor has linked to this study.
- Other trials for Emergency MedicineStudies of the same condition, open and under way.
- More trials run by Izmir Katip Celebi UniversityThe 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
- Cohort
- Time perspective
- Prospective
- Enrolment
- 80 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Izmir Katip Celebi University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Ejder Saylav BORA, Izmir Katip Celebi University
- Investigators
- BORA, MD PhD, Study director, Izmir Katip Çelebi University Faculty of Medicine
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07453277
- Sponsor's protocol ID
- IZMIR-KCU-02
- Acronym
- wakeupstroke
- Status last verified
- Mar 2026
- First submitted
- 1 Mar 2026
- Last updated
- 6 Mar 2026
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Publications
Simats A, Ramiro L, Garcia-Berrocoso T, Brianso F, Gonzalo R, Martin L, Sabe A, Gill N, Penalba A, Colome N, Sanchez A, Canals F, Bustamante A, Rosell A, Montaner J. A Mouse Brain-based Multi-omics Integrative Approach Reveals Potential Blood Biomarkers for Ischemic Stroke. Mol Cell Proteomics. 2020 Dec;19(12):1921-1936. doi: 10.1074/mcp.RA120.002283. Epub 2020 Aug 31.
PubMed 32868372Liu F, Chen C, Chen C, Parsons MW, Li G, Lin L; INSPIRE Study Group. Salvageable Time Window: Tissue Clock After Acute Ischemic Stroke Onset. Stroke. 2025 Nov;56(11):3165-3174. doi: 10.1161/STROKEAHA.125.051780. Epub 2025 Aug 7.
PubMed 40772304Zhang YL, Zhang JF, Wang XX, Wang Y, Anderson CS, Wu YC. Wake-up stroke: imaging-based diagnosis and recanalization therapy. J Neurol. 2021 Nov;268(11):4002-4012. doi: 10.1007/s00415-020-10055-7. Epub 2020 Jul 15.
PubMed 32671526Ho JP, Powers WJ. Contemporary Management of Acute Ischemic Stroke. Annu Rev Med. 2025 Jan;76(1):417-429. doi: 10.1146/annurev-med-050823-094312. Epub 2025 Jan 16.
PubMed 39496213Zhu F, Wang Z, Song J, Ji Y. Correlation analysis of inflammatory markers with the short-term prognosis of acute ischaemic stroke. Sci Rep. 2024 Aug 1;14(1):17772. doi: 10.1038/s41598-024-66279-4.
PubMed 39090131
Study at a glance
From the registry record, last updated by the sponsor on 6 Mar 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- The Role of Blood-Based Molecular Clock Biomarkers in Predicting the Onset Time of Acute Ischemic Stroke: A Prospective Observational Study
- ClinicalTrials.gov ID
- NCT07453277
- Acronym / sponsor ID
- wakeupstroke / IZMIR-KCU-02
- Conditions
- Emergency Medicine, Stroke Acute
- Keywords
- molecular clock biomarkers, wake up stroke, acute stroke
- Study type
- Observational
- Recruitment status
- Active, not recruiting
- Enrolment
- 80 participants (estimated)
- Lead sponsor
- Izmir Katip Celebi UniversityUniversity, hospital or other
- Study start
- 1 Mar 2026 (actual)
- Primary completion
- 1 Mar 2027 (estimated)
- Study completion
- 1 Apr 2027 (estimated)
- First posted
- 5 Mar 2026 (actual)
- 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.
Acute ischemic stroke (AIS) is a major cause of mortality and long-term neurological disability worldwide. The effectiveness of reperfusion therapies such as intravenous thrombolysis and mechanical thrombectomy is highly dependent on the time elapsed since symptom onset. However, in approximately 15-25% of patients, the exact onset time cannot be determined because symptoms begin during sleep (wake-up stroke) or the onset is otherwise unclear. This uncertainty often prevents patients from receiving time-dependent reperfusion treatments.
Currently, imaging-based approaches such as diffusion-weighted imaging-fluid attenuated inversion recovery (DWI-FLAIR) mismatch are used to estimate the biological stage of ischemia in patients with unknown onset time. However, advanced imaging techniques may not be available in all centers and interpretation may vary.
This study aims to evaluate the diagnostic performance of a multi-biomarker panel representing different biological components of ischemic brain injury, including glial, neuronal, axonal, cellular stress, and vascular responses. Blood samples obtained at admission will be analyzed for glial fibrillary acidic protein (GFAP), ubiquitin C-terminal hydrolase L1 (UCH-L1), serum neurofilament light chain (sNfL), phosphatidylethanolamine-binding protein 1 (PEBP1), and matrix metalloproteinase-9 (MMP-9).
The primary objective is to determine whether this biomarker panel can distinguish patients presenting within ≤4.5 hours from those presenting after >4.5 hours of symptom onset. Biomarker findings will be compared with imaging-based reference methods to explore the feasibility of a blood-based "molecular clock" approach for estimating stroke timing in patients with uncertain onset.
Detailed description
Acute ischemic stroke (AIS) is one of the leading causes of mortality and long-term neurological disability worldwide. The effectiveness of reperfusion therapies, including intravenous thrombolysis and mechanical thrombectomy, is highly dependent on the time elapsed since symptom onset. Determination of the symptom onset time is therefore a critical component of treatment eligibility. However, a substantial proportion of patients present with stroke symptoms of unknown onset, most commonly because the symptoms develop during sleep (wake-up stroke) or because the exact onset time cannot be reliably established. This uncertainty may prevent eligible patients from receiving time-dependent reperfusion therapies.
Current clinical decision-making in patients with uncertain onset time relies largely on imaging-based approaches that attempt to estimate the biological stage of ischemia. The diffusion-weighted imaging-fluid attenuated inversion recovery (DWI-FLAIR) mismatch concept is the most widely used method and is based on the hypothesis that tissue signal evolution reflects the duration of ischemia. Advanced perfusion imaging techniques have also been incorporated into clinical practice. However, these imaging methods require specialized equipment and expertise, may not be available in all centers, and their interpretation may vary between institutions. Consequently, there is increasing interest in identifying circulating biomarkers that can reflect the biological timing of ischemic injury.
Ischemic brain injury initiates a complex cascade of pathophysiological processes involving astroglial activation, neuronal membrane disruption, axonal injury, inflammatory signaling, cellular stress responses, and vascular dysfunction. These processes evolve dynamically over time and lead to the release of measurable molecular components into the systemic circulation. Biomarkers reflecting different cellular compartments of the neurovascular unit may therefore provide complementary information regarding the temporal evolution of ischemic injury.
Several candidate biomarkers have been identified that represent different biological aspects of this process. Glial fibrillary acidic protein (GFAP) is an astrocyte-specific structural protein that reflects astroglial injury and early glial activation following acute brain damage. Ubiquitin C-terminal hydrolase L1 (UCH-L1) is a neuron-specific cytoplasmic enzyme released after neuronal membrane disruption and has been proposed as an indicator of acute neuronal injury. Serum neurofilament light chain (sNfL) is a structural component of the axonal cytoskeleton and is considered a marker of axonal degeneration and structural neuronal damage. Phosphatidylethanolamine-binding protein 1 (PEBP1), also known as Raf kinase inhibitory protein, is involved in the regulation of cellular signaling pathways and stress responses and may reflect cellular adaptation to ischemic stress. Matrix metalloproteinase-9 (MMP-9) is associated with inflammatory activation, extracellular matrix degradation, and blood-brain barrier dysfunction during the evolution of ischemic brain injury.
The combined evaluation of biomarkers representing multiple biological layers of the neurovascular unit may provide a more comprehensive representation of the temporal dynamics of ischemic injury than single-marker approaches. A multi-biomarker strategy has the potential to capture different phases of the ischemic cascade, including glial activation, neuronal damage, axonal injury, cellular stress response, and vascular dysfunction.
The present study aims to investigate whether a multi-compartment biomarker panel can contribute to the estimation of the biological timing of acute ischemic stroke. By evaluating circulating biomarkers representing different components of the neurovascular unit, the study seeks to explore the feasibility of a blood-based molecular signature that reflects the temporal evolution of ischemic injury.
The findings of this study may contribute to the development of a biologically informed approach for estimating stroke timing and may support clinical decision-making in patients presenting with uncertain symptom onset, particularly in settings where advanced imaging techniques are not readily available.
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| ACUTE STROKE PRESENTING TO THE EMERGENCY DEPARTMENT-1 | – | –ACUTE STROKE PRESENTING TO THE EMERGENCY DEPARTMENT (WITNESSED STROKE, STROKE WITH KNOWN OCCURRENCE) |
| ACUTE WAKE UP STROKE PRESENTING TO THE EMERGENCY DEPARTMENT-2 | – | –WAKE UP STROKE (Without Witnesses and Unknown Start Time) |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- Patients with acute ischemic stroke whose onset time is unknown or who present with a wake-up stroke. Serum/plasma samples obtained from venous blood samples taken during routine clinical practice in all patients will be analyzed for GFAP, UCH-L1, sNfL, PEBP1, and MMP-9 levels. Patients' demographic data, clinical characteristics, NIHSS scores, and magnetic resonance imaging (MRI) findings (particularly DWI-FLAIR mismatch status) will be recorded from the electronic patient record system. The performance of the multi-compartment molecular panel formed by the obtained biomarker levels in distinguishing the biological time window of acute ischemic stroke (≤4.5 hours vs. >4.5 hours) will be evaluated by comparing it with the imaging-based reference method.
Key inclusion criteria (3 listed)
- Be 18 years of age or older
- Presence of acute focal neurological deficit
- Presentation within ≤24 hours of the last time the patient was well
Key exclusion criteria (6 listed)
- Intracranial hemorrhage
- Active infection or sepsis
- Major surgery/trauma within the last 14 days
- Active autoimmune disease
- Stroke within the last 3 months
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 performance of the multi-biomarker panel in identifying the biological time window of acute ischemic stroke (≤4.5 hours vs >4.5 hours from symptom onset)
Time frame: At emergency department admission.
The primary outcome will be the ability of the combined biomarker panel (GFAP, UCH-L1, sNfL, PEBP1, and MMP-9) measured from admission blood samples to discriminate patients presenting within ≤4.5 hours versus >4.5 hours after symptom onset. Diagnostic performance will be evaluated using receiver operating characteristic (ROC) curve analysis and reported as area under the curve (AUC), sensitivity, specificity, and optimal cut-off values.
4 secondary outcomes
Diagnostic performance of individual biomarkers
Time frame: At emergency department admission.
Association between biomarker levels and imaging-based reference methods
Time frame: Baseline imaging obtained at hospital admission.
Incremental diagnostic value of the combined biomarker model
Time frame: At emergency department admission.
Correlation between circulating biomarker levels and infarct volume on diffusion-weighted imaging (DWI)
Time frame: Baseline imaging obtained within the initial diagnostic evaluation after hospital admission.
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 6 Mar 2026.
- Background: PubMed 32868372Simats A, Ramiro L, Garcia-Berrocoso T, Brianso F, Gonzalo R, Martin L, Sabe A, Gill N, Penalba A, Colome N, Sanchez A, Canals F, Bustamante A, Rosell A, Montaner J. A Mouse Brain-based Multi-omics Integrative Approach Reveals Potential Blood Biomarkers for Ischemic Stroke. Mol Cell Proteomics. 2020 Dec;19(12):1921-1936. doi: 10.1074/mcp.RA120.002283. Epub 2020 Aug 31.
- Background: PubMed 40772304Liu F, Chen C, Chen C, Parsons MW, Li G, Lin L; INSPIRE Study Group. Salvageable Time Window: Tissue Clock After Acute Ischemic Stroke Onset. Stroke. 2025 Nov;56(11):3165-3174. doi: 10.1161/STROKEAHA.125.051780. Epub 2025 Aug 7.
- Background: PubMed 32671526Zhang YL, Zhang JF, Wang XX, Wang Y, Anderson CS, Wu YC. Wake-up stroke: imaging-based diagnosis and recanalization therapy. J Neurol. 2021 Nov;268(11):4002-4012. doi: 10.1007/s00415-020-10055-7. Epub 2020 Jul 15.
- Background: PubMed 39496213Ho JP, Powers WJ. Contemporary Management of Acute Ischemic Stroke. Annu Rev Med. 2025 Jan;76(1):417-429. doi: 10.1146/annurev-med-050823-094312. Epub 2025 Jan 16.
- Background: PubMed 39090131Zhu F, Wang Z, Song J, Ji Y. Correlation analysis of inflammatory markers with the short-term prognosis of acute ischaemic stroke. Sci Rep. 2024 Aug 1;14(1):17772. doi: 10.1038/s41598-024-66279-4.
- Individual participant dataSharing planned: No
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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.
BORA, MD PhD study director
Izmir Katip Çelebi University Faculty of Medicine
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 Emergency Medicine and Stroke Acute, run by Izmir Katip Celebi University at 1 site in Turkey (Türkiye).
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 3 inclusion and 6 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: under way, not looking for participants, as of the sponsor's last update on 6 Mar 2026. 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 Turkey (Türkiye). 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?
This study is still under way. Results are not available in the source record yet.
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 performance of the multi-biomarker panel in identifying the biological time window of acute ischemic stroke (≤4.5 hours vs >4.5 hours from symptom onset) (time frame: At emergency department admission.). 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 NCT07453277, which also lists 5 linked publications.
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 6 Mar 2026.