Actively Recruiting

Age: 18Years +
All Genders
ID06121336

PRecisiOn Medicine In StrokE Study on the Evolution of Plasma Brain-Derived Tau in 100 Patients With Acute Ischemic Stroke

Led by Ludwig-Maximilians - University of Munich · Updated on 2025-09-04

100

Participants Needed

1

Research Sites

13 weeks

Total Duration

On this page

AI-Summary

What this Trial Is About

Researchers are investigating brain-derived tau (BD-tau) as a blood-based biomarker for brain injury in acute ischemic stroke. Previous studies showed BD-tau levels correlate with brain injury and can predict functional outcomes, but the timing and progression of BD-tau changes after stroke onset are not fully understood. This study aims to track BD-tau levels hourly from admission up to 48 hours after stroke onset to better understand when BD-tau rises and plateaus. The study will include 100 patients diagnosed with acute ischemic stroke caused by a large- or medium-vessel occlusion within 9 hours of symptom onset. BD-tau and other brain injury markers like Neurofilament Light Chain will be measured every hour from admission to 48 hours after stroke onset using a blood test. Clinical data and neuroimaging results will be collected during hospitalization, and patients will be followed up clinically at 3 months. Participants will undergo frequent blood sampling to monitor BD-tau levels and have imaging assessments upon admission. Researchers will evaluate brain injury and infarct progression using CT and MRI scans, along with functional outcomes at 7 and 90 days after stroke. The study focuses on understanding the evolution of BD-tau as a marker of brain injury and its relationship with stroke progression and recovery over time.

CONDITIONS

Brief Title

PRecisiOn Medicine In StrokE: Evolution of Plasma Brain-Derived Tau in Acute Stroke

Who Can Participate

Age: 18Years +
All Genders

Eligibility Criteria

Eligible

You may qualify if you...

  • Clinical diagnosis of acute ischemic stroke
  • Presentation within 9 hours of symptom onset
  • Large- or medium-vessel occlusion confirmed by CT or MRI angiography
  • At least 18 years of age
  • Written informed consent
Not Eligible

You will not qualify if you...

  • CT or MRI showing intracranial hemorrhage upon admission
  • History of ischemic stroke, subarachnoid hemorrhage, intracerebral hemorrhage, subdural hematoma, epidural hematoma, CNS tumor, meningitis, or encephalitis within the last three months
  • Severe renal dysfunction (eGFR < 30ml/min/1.73m2)
  • Dementia
  • Pre-stroke disability with a modified Rankin Scale score greater than 1

AI-Screening

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Your Study Journey

Screening

Duration - 2 to 4 weeks

Participants are screened for eligibility to participate in the trial.

Diagnostic Evaluation

Duration - Up to 9 hours from symptom onset

Participants undergo assessment including neuroimaging and blood tests upon admission to confirm acute ischemic stroke due to large- or medium-vessel occlusion.

1 visit (in-person) upon admission

Monitoring

Duration - 48 hours

Participants have plasma BD-tau levels and other markers of brain injury assessed every hour from admission to 48 hours after stroke onset to monitor stroke progression.

Hourly blood sampling for up to 48 hours

Long-term Monitoring

Duration - Up to 3 months

Participants are followed clinically to assess functional outcomes at 7 days and 90 days after stroke onset.

2 follow-up visits at 7 days and 90 days after onset

Trial Site Locations

Total: 1 location

1

LMU University hospital, LMU Munich

Munich, Bavaria, Germany, 81377

Actively Recruiting

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Research Team

S

Steffen Tiedt, MD PhD

How is the study designed?

Study Type

OBSERVATIONAL

Masking

N/A

Allocation

N/A

Model

N/A

Primary Purpose

N/A

Number of Arms

1

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Published Research Related To This Trial

Global, regional, and national burden of stroke and its risk factors, 1990-2019: a systematic analysis for the Global Burden of Disease Study 2019.

GBD 2019 Stroke Collaborators

https://pubmed.ncbi.nlm.nih.gov/34487721

Intravenous alteplase for stroke with unknown time of onset guided by advanced imaging: systematic review and meta-analysis of individual patient data.

Götz Thomalla, Florent Boutitie, Henry Ma...

https://pubmed.ncbi.nlm.nih.gov/33176180

Endovascular thrombectomy after large-vessel ischaemic stroke: a meta-analysis of individual patient data from five randomised trials.

Mayank Goyal, Bijoy K Menon, Wim H van Zwam...

https://pubmed.ncbi.nlm.nih.gov/26898852

Guidelines for the Early Management of Patients With Acute Ischemic Stroke: 2019 Update to the 2018 Guidelines for the Early Management of Acute Ischemic Stroke: A Guideline for Healthcare Professionals From the American Heart Association/American Stroke Association.

William J Powers, Alejandro A Rabinstein, Teri Ackerson...

https://pubmed.ncbi.nlm.nih.gov/31662037

European Stroke Organisation - European Society for Minimally Invasive Neurological Therapy expedited recommendation on indication for intravenous thrombolysis before mechanical thrombectomy in patients with acute ischaemic stroke and anterior circulation large vessel occlusion.

Guillaume Turc, Georgios Tsivgoulis, Heinrich J Audebert...

https://pubmed.ncbi.nlm.nih.gov/35300256

European Stroke Organisation (ESO) - European Society for Minimally Invasive Neurological Therapy (ESMINT) Guidelines on Mechanical Thrombectomy in Acute Ischaemic StrokeEndorsed by Stroke Alliance for Europe (SAFE).

Guillaume Turc, Pervinder Bhogal, Urs Fischer...

https://pubmed.ncbi.nlm.nih.gov/31165090

Clinical Imaging Factors Associated With Infarct Progression in Patients With Ischemic Stroke During Transfer for Mechanical Thrombectomy.

Gregoire Boulouis, Arne Lauer, Ahmer Khawdja Siddiqui...

https://pubmed.ncbi.nlm.nih.gov/28973081