NCT06121336 PRecisiOn Medicine In StrokE: Evolution of Plasma Brain-Derived Tau in Acute Stroke
| NCT ID | NCT06121336 |
| Status | Recruiting |
| Phase | — |
| Sponsor | Ludwig-Maximilians - University of Munich |
| Condition | Stroke |
| Study Type | OBSERVATIONAL |
| Enrollment | 100 participants |
| Start Date | 2023-03-01 |
| Primary Completion | 2026-06-30 |
Eligibility & Interventions
Eligibility Fast-Check
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What to Expect as a Participant
This is an observational study. You will not receive an experimental treatment; researchers will collect data based on your existing condition or standard treatment.
This trial targets 100 participants in total. It began in 2023-03-01 with a primary completion date of 2026-06-30.
⚠ This information is for research awareness only. Always consult your physician before joining any clinical trial. Participation is voluntary and you may withdraw at any time.
Brief Summary
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.
Eligibility Criteria
Inclusion Criteria: * clinical diagnosis of acute ischemic stroke * presentation within 9 hours of symptom onset * large- or medium-vessel occlusion (i.e. an occlusion of the ICA, MCA \[segments M1-M4\], ACA \[segments A1-A3\], basilar artery, or PCA \[segments P1 to P3\]) confirmed by CT or MRI angiography * at least 18 years of age * written informed consent Exclusion Criteria: * CT or MRI showing intracranial hemorrhage upon admission * A 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 defined as a premorbid modified Rankin Scale score \> 1
Contact & Investigator
Frequently Asked Questions
Who can join the NCT06121336 clinical trial?
This trial is open to participants of all sexes, aged 18 Years or older, studying Stroke. Full inclusion and exclusion criteria are listed in the Eligibility Criteria section. Always confirm your eligibility with the research team before applying.
Is NCT06121336 currently recruiting?
Yes, NCT06121336 is actively recruiting participants. Contact the research team at steffen.tiedt@med.uni-muenchen.de for enrollment information.
Where is the NCT06121336 trial being conducted?
This trial is being conducted at Munich, Germany.
Who is sponsoring the NCT06121336 clinical trial?
NCT06121336 is sponsored by Ludwig-Maximilians - University of Munich. The trial plans to enroll 100 participants.
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