About the study

WAKE-IN is a clinical trial evaluating the use of mechanical thrombectomy in patients with acute ischemic stroke who do not meet current standard eligibility criteria for endovascular treatment.

The project focuses on patients with large vessel occlusion (LVO) in cerebral arteries whose symptom onset time is unknown or who are not eligible for treatment based on computed tomography criteria.

The aim of the study is to identify patients who may still benefit from mechanical thrombectomy despite not meeting current treatment eligibility criteria.

What is ischemic stroke?

Ischemic stroke occurs when blood flow to part of the brain is suddenly blocked, most commonly due to an artery being occluded by a blood clot.

In the case of large vessel occlusion, the risk of severe disability and death is particularly high because a large area of the brain is affected by the loss of blood supply.

Rapid restoration of blood flow is critical for limiting the extent of brain injury and improving patient outcomes.

Why is mechanical thrombectomy so important?

Mechanical thrombectomy is one of the most effective treatments for acute ischemic stroke caused by large vessel occlusion.

The procedure involves removing the clot from the blocked vessel and restoring blood flow to the affected area of the brain.

As a result, treatment can significantly increase the chances of avoiding severe long-term disability and improve functional recovery after stroke.

Why is this study needed?

Currently, eligibility for thrombectomy is determined mainly by the time since symptom onset and the extent of brain injury visible on computed tomography.

In practice, this means that some patients with acute ischemic stroke do not receive invasive treatment even though they may still benefit from it.

The WAKE-IN study investigates whether more precise patient selection based on magnetic resonance imaging can make treatment available to an additional group of patients.

The role of MRI and DWI-FLAIR mismatch

The project uses magnetic resonance imaging with assessment of the so-called DWI-FLAIR mismatch.

This parameter may help determine the relationship between brain tissue that has already suffered irreversible damage and tissue that may still be salvageable if blood flow is restored.

The study hypothesis assumes that among patients who do not meet current eligibility criteria, there is a significant group who can be effectively identified using a short MRI protocol.

Study design

WAKE-IN is a randomised clinical trial with blinded assessment of long-term clinical outcomes.

The study compares mechanical thrombectomy combined with standard stroke unit care and follow-up treatment against conservative treatment combined with standard stroke unit care.

Primary outcome measures include functional status at 90 days and changes in the volume of brain injury assessed by imaging studies.

Study population

Eligible participants include patients with acute ischemic stroke caused by large vessel occlusion who do not meet current eligibility criteria for endovascular treatment.

This includes patients with unknown symptom onset time, individuals outside the standard treatment time window and patients with low ASPECTS values on computed tomography.

Eligibility additionally requires the presence of a DWI-FLAIR mismatch on MRI, according to the study protocol.

Research team

The national coordinator and principal investigator is Bartosz Karaszewski, MD, PhD, Professor from the Department and Clinic of Adult Neurology, Medical University of Gdańsk and the University Clinical Centre in Gdańsk.

A co-principal investigator of the project is Adam Stępień, MD, PhD, Professor from the Department of Neurology at the Military Institute of Medicine – National Research Institute in Warsaw.

The project is conducted by the Medical University of Gdańsk as the coordinating institution in collaboration with the Military Institute of Medicine – National Research Institute.

Organisational information

The project is funded by the Polish state budget through the Medical Research Agency (MRA) under the funding call for non-commercial clinical trials in psychiatry and neurology (call number: ABM/2021/2).

Project number: 2021/ABM/02/00018.

Funding amount: PLN 9,995,731.70.

Project duration: 01 December 2021 – 30 November 2027.