An observational study in Stroke, Stroke, Acute and Stroke, Ischemic, sponsored by Ludwig-Maximilians - University of Munich. Recruiting at 1 site in Germany. Open to participants aged 18 Years and older. Per ClinicalTrials.gov, last updated 2026-08-20.
Sponsored by Ludwig-Maximilians - University of Munich · Observational
The investigators recently identified Brain-derived tau (BD-tau) as a sensitive blood-based biomarker for brain injury in acute ischemic stroke: in patients with acute ischemic stroke, plasma BD-tau was associated with imaging-based metrics of brain injury upon admission, increased within the first 24 hours in correlation with infarct progression, and at 24 hours was superior to final infarct volume in predicting 90-day functional outcome. While informing on the relation of BD-tau with imaging-based metrics of brain injury, this cross-sectional study was restricted to BD-tau assessments upon admission and at day 2 and could not inform on key characteristics of the evolution of plasma BD-tau, including when exactly it starts to rise, how long it continues to rise, and how it is determined by infarct characteristics as well as comorbidities. Here, the investigators aim to assess plasma BD-tau every hour from admission to 48 hours after onset to evaluate the hypothesis that BD-tau rises immediately after onset and plateaus between three and 48 hours after onset.
Ischemic stroke remains a leading cause of death and long-term disability worldwide,1 despite major advancements in reperfusion therapies.2,3 While neuroimaging modalities have expanded patient eligibility for reperfusion therapies by estimating ischemic core and salvageable tissue,4-7 their assessments are mostly single-timed. Currently available clinical algorithms lack the capacity to continuously track the dynamic evolution of how the primary core progresses to a final infarct, which, however, is a major determinant of functional outcome.8-10 Monitoring infarct trajectories could support therapeutic decision-making in patients with large-vessel occlusion stroke and unveil determinants of stroke progression, aiding in patient selection for trials evaluating cytoprotection11 and targeting clinically ineffective reperfusion.12 Previously studied blood-based biomarkers such as Neurofilament Light Chain (NfL),13 neuron-specific enolase (NSE),14 glial fibrillary acidic protein (GFAP),15,16 and S 100 calcium-binding protein B (S100B)17 either failed to capture the extent of brain injury within the acute phase of stroke or lack specificity. Plasma levels of brain-derived tau (BD-tau) were recently found to show high value for monitoring brain injury in patients with acute ischemic stroke: In 502 patients with acute IS, plasma BD-tau was associated with imaging-based metrics of brain injury upon admission, increased within the first 24 hours in correlation with infarct progression, and at 24 hours was superior to final infarct volume in predicting 90-day functional outcome.18 While informing on the relation of BD-tau with imaging-based metrics of brain injury, this large cross-sectional study was restricted to BD-tau assessments upon admission (median time from onset: 4.4 hours) and at day 2 (median time from onset: 22.7 hours) and could not inform on key characteristics of the evolution of plasma BD-tau, including when exactly it starts to rise, how long it continues to rise, and how it is determined by infarct characteristics as well as comorbidities. That knowledge would be of great value to determine the responsiveness of plasma BD-tau to brain injury after onset and to evaluate whether BD-tau plateaus at different time points after onset indicating no further infarct progression. Here, the investigators hypothesize that BD-tau rises immediately after onset and plateaus between three and 48 hours after onset. PROMISE-BD-100 will thus assess BD-tau levels every hour from admission to 48 hours from stroke onset in patients that present with the clinical diagnosis of an acute ischemic stroke due to a large- or medium-vessel occlusion within 9 hours from symptom onset.
2,612 studies on the registry are indexed under Ischemic Stroke; 971 are open to participants now.
This study's planned enrollment of 100 is below the median of 300 across 771 observational studies indexed under Ischemic Stroke.
Browse Ischemic Stroke studies →Ludwig-Maximilians - University of Munich is the lead sponsor of 223 studies on the registry; 29 are open to participants now.
Compared within Ischemic Stroke, this study's primary condition as ClinicalTrials.gg classifies it; the registry's first condition term is Stroke. The counts are of registry records indexed under each term, refreshed daily. How we classify →
Patients will be recruited upon admission to a tertiary care hospital.
Go through the criteria one by one — yes, no or not sure — and take the list to your doctor or the study team. Kept in this browser only.
Exclusion Criteria:
Underlined terms in the criteria open these too. Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Before you join, the study team explains what taking part involves — its purpose, what happens, the risks and possible benefits — and answers your questions, so you can decide freely. Consent is usually recorded on a form (the informed consent form, ICF) signed by you or, where the law allows, by someone legally authorised to decide for you.
You can keep asking questions during the study, you are told of new information that matters, and you can choose to leave at any time.
Informed consent
Before you join, the study team explains what taking part involves — its purpose, what happens, the risks and possible benefits — and answers your questions, so you can decide freely. Consent is usually recorded on a form (the informed consent form, ICF) signed by you or, where the law allows, by someone legally authorised to decide for you.
You can keep asking questions during the study, you are told of new information that matters, and you can choose to leave at any time.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
100 patients admitted to a specialized stroke service because of an acute ischemic stroke due to large- or medium-vessel occlusion within 9 hours of stroke onset. BD-tau levels and other suggested markers of brain injury (e.g.. NfL) will be assessed every hour from admission to 48 hours after onset. Routinely collected clinical data including from neuroimaging will be collected throughout hospitalization. Clinical follow-up will be performed at 3 months.
Diagnostic Test: Plasma levels of BD-tau
Plasma levels of BD-tau will be assessed using a single-molecule array assay.
The primary outcome are plasma BD-tau levels in acute ischemic stroke.
The evolution of BD-tau levels will be characterized by: * the time point when plasma BD-tau levels start to rise after onset (defined as the earliest time point \[in relation to onset\] that showed higher BD-tau levels compared with the previous assessment and lower levels compared with the next assessment), * the type of rise (e.g. linear, exponential, or logarithmic), and * until when plasma BD-tau levels continue to rise (defined as the time point \[in relation to onset\] compared to which BD-tau levels do not increase by ≥ 5 % compared to 1h, 2h, and 3h afterwards). 5 % were chosen without prior knowledge and in an attempt to account for assay-dependent variations of BD-tau quantifications (coefficient of variation 8-9 %)18 while keeping a biologically and clinically plausible value (rather than e.g. 10 %).
Time frame: Every hour from admission to 48 hours after onset.
ASPECTS on non-contrast CT
Time frame: Upon admission
Ischemic core volume on CT perfusion
Time frame: Upon admission
Regional leptomeningeal collateral score on CT angiography
Time frame: Upon admission
Final infarct volume
Final infarct volume will be assessed on delayed neuroimaging (CT or MRI), at least 48 after symptom onset.
Time frame: Between 48 hours after symptom onset and discharge (latest 10 days after onset)
Infarct progression
Infarct progression is defined as the difference between ischemic core volume quantified on admission CT perfusion scans and infarct volume quantified on delayed neuroimaging.
Time frame: Between admission and discharge (latest 10 days after onset)
90-day functional outcome
Functional outcome at 90 days (± 14 days) will be assessed using the modified Rankin Scale (mRS). The mRS is a valid and reliable clinician-reported measure of global disability that has been widely applied for evaluating recovery from stroke. It is a scale used to measure functional recovery (the degree of disability or dependence in daily activities) of people who have suffered a stroke. mRS scores range from 0 (best outcome) to 6 (worst outcome), with 0 indicating no residual symptoms; 5 indicating bedbound, requiring constant care; and 6 indicating death.
Time frame: 90 days (± 14 days) after onset
7-day functional outcome
Functional outcome at 7 days (or discharge if earlier) will be assessed using the modified Rankin Scale (mRS). The mRS is a valid and reliable clinician-reported measure of global disability that has been widely applied for evaluating recovery from stroke. It is a scale used to measure functional recovery (the degree of disability or dependence in daily activities) of people who have suffered a stroke. mRS scores range from 0 (best outcome) to 6 (worst outcome), with 0 indicating no residual symptoms; 5 indicating bedbound, requiring constant care; and 6 indicating death.
Time frame: 7 days after onset
Early recurrent ischemic stroke
The diagnosis of an early recurrent ischemic stroke will be based on i) sudden onset of a new focal neurological deficit within the first seven days after the index stroke that can not be explained by other non-ischemic causes such as seizure, metabolic derangement, or other systemic conditions, and ii) the presence of a new DWI-positive lesion on MRI or a new ischemic lesion on a delayed CT scan that is distinct from the index stroke lesion and that is consistent with the new clinical symptoms.
Time frame: Between admission and discharge (latest 10 days after onset)
Secondary intracerebral hemorrhage
Secondary intracerebral hemorrhage is defined as a new intracerebral hemorrhage independent of the primary ischemic lesion that is observed between the initial hemorrhage-free neuroimaging scan and discharge
Time frame: Between admission and discharge (latest 10 days after onset)
Hemorrhagic transformation
The occurrence of hemorrhagic transformation will be evaluated based on the morphological ECASS criteria.20
Time frame: Between admission and discharge (latest 10 days after onset)
Plasma levels of NfL
Plasma levels of NfL will be assessed at an hourly basis using a single-molecule array assay.
Time frame: Hourly from admission to 48 hours after onset
Plasma levels of GFAP
Plasma levels of GFAP will be assessed at an hourly basis using a single-molecule array assay.
Time frame: Hourly from admission to 48 hours after onset
Plasma proteome and metabolome composition
Plasma proteome and metabolome composition will be assessed using mass spectrometry or alternatives.
Time frame: Hourly from admission to 48 hours after onset
Plan to share: Yes — Anonymized individual participant data, including data dictionaries, that underlie results in a publication, will be made available.
Supporting information: Study protocol, Statistical analysis plan, Analytic code
Time frame: IPD and additional supporting information will become available starting 6 months after publication.
Access criteria: IPD and additional supporting information will be shared with academic researchers with a reasonable request to the corresponding author of the respective publication.
Started Mar 2023 (actual). Primary completion is estimated for Dec 2026, 45 months after the start.
Of 394 non-industry observational studies under Ischemic Stroke, half reached primary completion within 56 months of starting (the median), counting those still running; a quarter within 25 and three quarters within 140. This study's planned 45 months is below that.
Counting every sponsor, half of 436 studies reached it within 53 months; a quarter within 24 and three quarters within 127.
How these figures are worked out, and which studies are left out of them.
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