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Ischemic StrokeDYNASTROKENCT05273216

Reperfusion Injury After Endovascular Stroke Treatment

An observational study of Ischemic Stroke, run by Medical University of Graz at 3 sites in Austria.

Recruiting

Looking for participants now. Contact the study team or a site below to ask about taking part.

Sites and contacts
Official record
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Trial summary

Endovascular stroke treatment with mechanical thrombectomy (MT) has become the standard therapy for intracranial large vessel occlusion (LVO). The most serious MT-related complication is secondary intracranial hemorrhage (ICH) occurring in 20-25%. Read more about this study

Who is it for?
Ages 18 years and older
Conditions the study is for
Ischemic Stroke
What is being tested?
Transcranial Duplex Sonography, Brain MRI and Blood biomarkers
How many people
600 participants
Where
3 sitesAustria
Study dates
1 Oct 2021to Jul 2026
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 due to large vessel occlusion of the anterior cerebral circulation (internal carotid artery, middle cerebral artery) receiving mechanical thrombectomy.

Who may be able to join

  • stroke due to large vessel occlusion of the anterior cerebral circulation (internal carotid artery, middle cerebral artery) receiving mechanical thrombectomy.

Who cannot join

  • basilar artery occlusion
  • age below 18 years

Trial locations and contacts

3 sites in 1 country. Contact the study team or a site near you to ask about taking part.

Thomas Gattringer, MD, PhD contact

004331638580231

thomas.gattringer@medunigraz.at

Markus Kneihsl, MD, PhD contact

004331638582984

markus.kneihsl@medunigraz.at

Austria3 sites, 3 recruiting
  • Medical Univerity of Graz, Department of Neurology

    Graz, Styria, 8036

    Thomas Gattringer, MD, PhD, 004331638580231, thomas.gattringer@medunigraz.at

    Markus Kneihsl, MD, PhD, 004331638582984, markus.kneihsl@medunigraz.at

    Recruiting
  • Medical University of Innsbruck, Department of Neurology

    Innsbruck, Tyrol, 6020

    Michael Knoflach, MD, +43-512-504-81697, michael.knoflach@i-med.ac.at

    Not yet recruiting
  • Paracelsus Medical University, Department of Neurology

    Salzburg, 5020

    Sebastian Mutzenbach, MD, 00435725556039, j.mutzenbach@salk.at

    Not yet recruiting

Other trials in Austria

About this study

Official title: Hemodynamic Changes and Reperfusion Injury After Endovascular Stroke Treatment: Prospective Multicenter DYNASTROKE STUDY

Endovascular stroke treatment with mechanical thrombectomy (MT) has become the standard therapy for intracranial large vessel occlusion (LVO). The most serious MT-related complication is secondary intracranial hemorrhage (ICH) occurring in 20-25%. Post- recanalization hyperperfusion might be an important risk factor/mechanism of MT-related ICH. In pilot studies, bedside transcranial Duplex sonography (TCD) was identified as a promising screening tool for cerebral hyperperfusion predicting ICH - the hallmark feature of reperfusion injury.

There is an unmet need to identify risk factors for ICH after MT as it relates to poor prognosis, no proven treatment is available, and it delays/prohibits usage of anticoagulants/-thrombotics necessary for preventing recurrent stroke.

Read more

Main objectives:

To explore the range and clinical impact of hemodynamic changes after MT as detected on bedside TCD.

To assess whether patients with increased blood flow velocity in the recanalized middle cerebral artery (MCA) are at a higher risk to develop ICH / vasogenic brain edema (reperfusion injury) after MT.

To investigate if the underlying mechanism is cerebral hyperperfusion (confirmed by perfusion MRI).

To additionally study the role of blood biomarkers of blood-brain-barrier / endothelial dysfunction and neuroaxonal damage on reperfusion injury and short-term prognosis.

Approach / methods:

Prospective, longitudinal Austrian multicentre study conducted at three high-volume stroke centers (Graz, Innsbruck, Salzburg). The investigators will recruit consecutive stroke patients with anterior circulation L VO treated by MT. Immediately after MT, experienced sonographers will perform bedside TCD to determine MCA blood flow status, which will be repeated after 24-48h and on day 7. On day one after MT, brain MRI with perfusion serves to assess infarct size, secondary ICH, (vasogenic) brain edema and perfusion status. MRI will be centrally analyzed in the neuroimaging lab of Graz, blinded to clinical, laboratory and sonographic information. Blood samples for the analysis of biomarkers of endothelial (blood-brain barrier) dysfunction and neuroaxonal damage (neurofilament light) will be taken on day one and at three months post-MT. Neurological outcome will be rated according to the modified Rankin Scale at three months post-stroke.

Read the detailed description

Endovascular stroke treatment with mechanical thrombectomy (MT) has become the standard therapy for intracranial large vessel occlusion (LVO). The most serious MT-related complication is secondary intracranial hemorrhage (ICH) occurring in 20-25%. Post- recanalization hyperperfusion might be an important risk factor/mechanism of MT-related ICH. In pilot studies, bedside transcranial Duplex sonography (TCD) was identified as a promising screening tool for cerebral hyperperfusion predicting ICH - the hallmark feature of reperfusion injury.

There is an unmet need to identify risk factors for ICH after MT as it relates to poor prognosis, no proven treatment is available, and it delays/prohibits usage of anticoagulants/-thrombotics necessary for preventing recurrent stroke.

Main objectives:

To explore the range and clinical impact of hemodynamic changes after MT as detected on bedside TCD.

To assess whether patients with increased blood flow velocity in the recanalized middle cerebral artery (MCA) are at a higher risk to develop ICH / vasogenic brain edema (reperfusion injury) after MT.

To investigate if the underlying mechanism is cerebral hyperperfusion (confirmed by perfusion MRI).

To additionally study the role of blood biomarkers of blood-brain-barrier / endothelial dysfunction and neuroaxonal damage on reperfusion injury and short-term prognosis.

Approach / methods:

Prospective, longitudinal Austrian multicentre study conducted at three high-volume stroke centers (Graz, Innsbruck, Salzburg). The investigators will recruit consecutive stroke patients with anterior circulation L VO treated by MT. Immediately after MT, experienced sonographers will perform bedside TCD to determine MCA blood flow status, which will be repeated after 24-48h and on day 7. On day one after MT, brain MRI with perfusion serves to assess infarct size, secondary ICH, (vasogenic) brain edema and perfusion status. MRI will be centrally analyzed in the neuroimaging lab of Graz, blinded to clinical, laboratory and sonographic information. Blood samples for the analysis of biomarkers of endothelial (blood-brain barrier) dysfunction and neuroaxonal damage (neurofilament light) will be taken on day one and at three months post-MT. Neurological outcome will be rated according to the modified Rankin Scale at three months post-stroke.

Level of originality:

Human studies on reperfusion injury after MT are lacking. If the investigator's hypothesis would hold true and the investigators could show that cerebral hemodynamic changes after MT would increase the risk for post-interventional intracranial bleeding complications and poor outcome, the investigators would provide an easy-available, repeatable bedside screening and monitoring tool (TCD), which has the potential to guide individualized patient treatment in the early postinterventional period after MT.

The study was registered on Clinicaltrials.gov after start of recruitment.

Conditions
Ischemic Stroke
Being tested
Transcranial Duplex Sonography, Brain MRI, Blood biomarkers
Keywords
Endovascular Stroke Treatment, Mechanical Thrombectomy, Reperfusion Injury, Intracranial Hemorrhage, Transcranial Duplex Sonography, Perfusion MRI, Cerebral Hyperperfusion
Medical subject headings
Ischemic Stroke, Reperfusion Injury, Intracranial Hemorrhages

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • Transcranial Duplex SonographyDiagnostic test

    Immediately after mechanical thrombectomy, patients will be investigated with bedside neurosonography (including TCD) at the stroke unit or neurointensive care unit. Apart from routine assessment of brain-supplying vessels, experienced sonographers will especially focus on intracranial blood flow velocities and determine the MCA mean blood flow velocity index (recanalized divided by contralateral artery). To assess potential dynamic blood flow changes, these investigations will be repeated at 24-48 hours after thrombectomy and at day 7 when we expect a (more) stable stroke phase. During these neurosonographic assessments, other important and potentially influential (hemodynamic) parameters such as blood pressure, heart rate and use of vasoactive medications will be documented. Assessment of intracranial blood flow will be standardized to dedicated measuring points.

  • Brain MRIDiagnostic test

    The investigators will use magnetic resonance imaging (MRI) and magnetic resonance angiography (MRA) routinely performed on day 1 after thrombectomy to assess (1) the size and location of acute ischemic damage including (vasogenic) cerebral edema formation, (2) hemorrhagic transformation, (3) concomitant chronic ischemic and hemorrhagic brain changes, and (4) patency of intracranial vessels. Contrast-enhanced or arterial spin labeling perfusion MRI will be used to (5) measure cerebral perfusion status. Findings from perfusion MRI will be correlated with blood flow information from TCD. MRI including MRA and perfusion sequences will be interpreted centrally in Graz as successfully demonstrated in previous large multicenter stroke studies.

  • Blood biomarkersDiagnostic test

    Apart from the assessment of outcome-relevant routine blood parameters of inflammation, coagulation, glucose metabolism, renal and liver function, the investigators will also investigate novel biomarkers of interest that could be indicative of endothelial damage / blood brain barrier disruption. Candidate markers for this purpose are interleukins (i.e., interleukin-6) and matrix metalloproteinases (i.e., MMP-9). Furthermore, the investigators will also measure neurofilament light chain protein as a marker for neuro-axonal damage that has been shown to indicate cerebral tissue destruction including vascular brain lesions with a very high sensitivity.

    For analysis, peripheral blood will be taken by venipuncture on day one and at follow- up three months after MT. Serum will be immediately stored at -80°C according to international consensus guidelines. Markers will be centrally analyzed in the neurological laboratory of the Department of Neurology, Medical University of Graz.

Study groups in NCT05273216
Study groupRoleWhat they receive
Observational Study (no different study arms)Prospective, longitudinal, multicenter, observational study to investigate hemodynamic changes (by TCD and perfusion MRI) and blood biomarkers as predictors of reperfusion injury / intracranial hemorrhage after stroke thrombectomy of the anterior cerebral circulation
Receives: Diagnostic Test: Transcranial Duplex Sonography; Diagnostic Test: Brain MRI; Diagnostic Test: Blood biomarkers

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. Rate of intracranial hemorrhage

    Rate of intracranial hemorrhage (indicator of reperfusion injury) on neuroimaging at day one after mechanical thrombectomy.

    Measured: Day one after mechanical thrombectomy

  2. Rate of (vasogenic) brain edema

    Rate of (vasogenic) brain edema (indicator of reperfusion injury) on neuroimaging at day one after mechanical thrombectomy.

    Measured: Day one after mechanical thrombectomy

Secondary outcomes (4)
  1. Cerebral blood flow changes on TCD

    The range of cerebral blood flow changes on TCD and its correlation with perfusion MRI.

    Measured: Immediately, 24-48 hours and 7 days post-thrombectomy, and after 3 months poststroke

  2. Change of symptomatic intracranial hemorrhage

    Rate of symptomatic intracranial hemorrhage post-thrombectomy.

    Measured: Immediately, 24-48 hours and 7 days post-thrombectomy.

  3. Inhospital mortality

    Early inhospital mortality

    Measured: Median inhospital stay of 7 days

  4. Change of functional neurological outcome

    Functional neurological outcome (according to the modified Rankin Scale with score of 0-6; higher scores indicating more severe disability) including mortality at three months post-stroke.

    Measured: Hospital discharge (median of 7 days) and after 3 months poststroke

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted10 Mar 2022
  2. Study start1 Oct 2021
  3. Primary completionJul 2026 (estimated)
  4. Study completionJul 2026 (estimated)

Resources

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
600 participants (estimated)
IDs, dates and publications
ClinicalTrials.gov ID
NCT05273216
Sponsor's protocol ID
EK 30-254 ex 17/18
Acronym
DYNASTROKE
Status last verified
Jun 2025
First submitted
15 Feb 2022
Last updated
13 Jun 2025
Results posted
No
Data monitoring committee
No
FDA-regulated drug
No
FDA-regulated device
No

Questions about this trial

What is this clinical trial studying?

An observational study of Ischemic Stroke, run by Medical University of Graz at 3 sites in Austria.

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 1 inclusion and 2 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: looking for participants now, as of the sponsor's last update on 13 Jun 2025. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 3 sites in Austria. 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?

Contact Thomas Gattringer, MD, PhD (004331638580231, thomas.gattringer@medunigraz.at), or a site near the patient. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Rate of intracranial hemorrhage (time frame: Day one after mechanical thrombectomy). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.

Where can I read the original study information?
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 13 Jun 2025.

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