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Stroke, IschemicIMPreSTNCT04035746

Microcirculation and Plasticity After Stroke

An observational study of Stroke, Ischemic, run by University of Zurich at 1 site in Switzerland.

Unknown status

Status not confirmed. The sponsor has not verified this record for over two years, so it may be out of date.

Official record
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Trial summary

Reperfusion is the main goal of early medical interventions after stroke, such as thrombolysis and thrombectomy. Recanalization works only if applied early - the earlier the better, but with a statistical cutoff of 4.5 hours where risk of hemorrhage outweighs the benefit. Read more about this study

Who is it for?
Ages 18 years and older
Conditions the study is for
Stroke, Ischemic
What is being tested?
Observation of microcirculation and plasticity of the brain
How many people
49 participants
Where
1 siteSwitzerland
Study dates
7 Oct 2019to 31 Jan 2022
Phase
Observational
Are there results?
None posted in the registry

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: Consecutively admitted to the hospital

Who may be able to join

  • ≤72h First-ever clinical ischemic stroke at hospital admission
  • Occlusion of M1-segment of the middle cerebral artery, and/ or intracranial internal carotid artery, and perfusion deficits with cortical involvement
  • 18 years or above
  • Living independent before stroke (mRS ≤3)
  • Written informed consent of the patient or the when the patient is not able to participate in the consenting procedure, the written authorization of an independent doctor who is not involved in the research project to safeguard the interests of the patient; in that case, post-hoc written informed consent of the patient is needed, or when the patient remains unable to participate in the informed consent procedure, written informed consent of a next of kind

Who cannot join

  • Major cardiac, psychiatric and/ or neurological diseases
  • Early seizures
  • Known or suspected non-compliance, drug and/ or alcohol abuse
  • Contra-indications for Magnetic Resonance Imaging and Transcranial Magnetic Stimulation, such as a history of seizure, prior electroconvulsive therapy, deep brain stimulators or other metal in the head, skull defect, pacemaker; neuroleptic medication; known allergic reaction to contrast material
  • Documented evidence that the patient does not want to participate in any scientific study or, in case of lack of documented evidence, no behavior and/or expression(s) that indicate(s) refusal of the patient to participate in research

Trial locations and contacts

1 site in 1 country.

Andreas R Luft, Prof. MD contact

+41 (0)44 255 54 00

andreas.luft@uzh.ch

Switzerland1 site, 1 recruiting
  • University Hospital Zurich

    Zurich, 8091

    Andreas R. Luft, Prof. MD, +41 (0)44 255 54 00, andreas.luft@uzh.ch

    Recruiting

Other trials in Switzerland

About this study

Official title: The Interplay of Microcirculation and Plasticity After Ischemic Stroke

Reperfusion is the main goal of early medical interventions after stroke, such as thrombolysis and thrombectomy. Recanalization works only if applied early - the earlier the better, but with a statistical cutoff of 4.5 hours where risk of hemorrhage outweighs the benefit. Recently, this cutoff has been put into perspective using standardized perfusion measurements by magnetic resonance imaging (MRI) or computed tomography (CT). Two trials have shown that revascularization is beneficial up to 24 hours after stroke onset if patient selection is based on perfusion imaging. This suggests interindividual differences in the temporal evolution of an infarction. One explanation for interindividual differences is the variability of the collateral blood supply to the brain, which in turn can maintain different perfusion pressures around the infarct core, also called the penumbra region. Insufficient recruitment of these collateral pathways is an independent negative predictor of poor outcome; the insufficiency may in part be explained by insufficient dilatation of arterioles ("low dilator reserve"). So far, interventions to improve collateral perfusion, e.g., induced hypertension, have not demonstrated effectiveness, likely because our understanding of collateral perfusion, demand-dependent dilatation of arteries (cerebrovascular reserve, CVR) and their effect on microcirculation is insufficient.

Functional recovery after a brain lesion is based on plasticity. Plasticity involves the creation of new synapses, fibers (axons and dendrites) and lasting modification to synaptic strength as well as the formation and migration of new neurons. In the cortex surrounding an infarct, plasticity is facilitated by ischemia via modification of gene expression, i.e. a certain time window after stroke, and is stimulated by activity and training. Tissue microcirculatory status and perfusion surrounding the stroke lesion may play a role in the formation of this plasticity. The investigators will analyze the contributions of pre-existing vascular networks, the impact of stroke-affected vessels, timing and degree of recanalization success, brain excitability, and short-term intra-cortical inhibition to better understand how these factors relate to functional recovery after stroke.

Being tested
Observation of microcirculation and plasticity of the brain
Keywords
Microcirculation, Plasticity, Cohort studies
Medical subject headings
Ischemic Stroke

What participants receive

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

  • Observation of microcirculation and plasticity of the brainOther

    Assessment of microcirculation, brain plasticity and clinical function

Study groups in NCT04035746
Study groupRoleWhat they receive
Single-group studyAssessment of microcirculation, brain plasticity and clinical function
Receives: Other: Observation of microcirculation and plasticity of the brain

What is being measured

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

  1. Change in brain microcirculation

    Change in microcirculation of the brain as measured by magnetic resonance imaging (MRI)

    Measured: <72 hours; 7, 45 and 90 days after stroke onset

  2. Change in brain plasticity

    Change in plasticity of the brain as measured by transcranial magnetic stimulation (TMS)

    Measured: 7, 45 and 90 days after stroke onset

Secondary outcomes (13)
  1. National Institutes of Health Stroke Scale

    Neurological impairments (scale range 0-42, higher values represent a worse outcome)

    Measured: <72 hours; 7, 45 and 90 days after stroke onset

  2. Fugl-Meyer Motor Assessment - Upper Extremity Subscale

    Upper limb motor function (scale range 0-66, higher values represent a better outcome)

    Measured: 7, 45 and 90 days after stroke onset

  3. Fugl-Meyer Motor Assessment - Lower Extremity Subscale

    Lower limb motor function (scale range 0-34, higher values represent a better outcome)

    Measured: 7, 45 and 90 days after stroke onset

  4. Finger extension 1

    Ability to extend the fingers (scale range 0-2, higher values represent a better outcome)

    Measured: <72 hours; 7, 45 and 90 days after stroke onset

  5. Finger extension 2

    Ability to extend the fingers (scale range 0-10, higher values represent a better outcome)

    Measured: <72 hours; 7, 45 and 90 days after stroke onset

  6. Finger extension 3

    Ability to extend the fingers (scale range 0-3, higher values represent a worse outcome)

    Measured: <72 hours; 7, 45 and 90 days after stroke onset

  7. Trunk Control Test

    Trunk ability (scale range 0-100, higher values represent a better outcome)

    Measured: 7 and 90 days after stroke onset

  8. Functional Ambulation Categories

    Walking ability (independence) (scale range 0-5, higher values represent a better outcome)

    Measured: <72 hours; 7, 45 and 90 days after stroke onset

  9. Ten-Meter Walk Test

    Gait speed and cadence (scale range is time in seconds, higher values represent a worse outcome)

    Measured: 7, 45 and 90 days after stroke onset

  10. Modified Rankin Scale

    Global disability (scale range 0-5, higher values represent a worse outcome)

    Measured: <72 hours; 7, 45 and 90 days after stroke onset

  11. Mobilization

    Amount of mobilization (scale range is time in minutes, higher values represent a better outcome)

    Measured: <72 hours; 7 days

  12. Concomitant movement therapy

    Intensity of therapy based on charts (scale range is time in minutes, higher values represent a better outcome)

    Measured: <72 hours; 7, 45 and 90 days after stroke onset

  13. Related Serious Events

    Serious Events (1. death; 2. life-threatening illness or injury; 3. in-patient or prolonged hospitalization; 4. medical or surgical intervention to prevent life threatening illness; 5. led to fetal distress, death or a congenital abnormality or birth defect)

    Measured: <72 hours; 7, 45 and 90 days after stroke onset

Timeline

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

  1. First posted29 Jul 2019
  2. Study start7 Oct 2019
  3. Primary completion31 Jan 2022 (estimated)
  4. Study completion31 Jan 2022 (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
49 participants (estimated)
IDs, dates and publications
ClinicalTrials.gov ID
NCT04035746
Sponsor's protocol ID
BASEC-Nr. 2019-00750
Acronym
IMPreST
Status last verified
Nov 2019
First submitted
15 Jul 2019
Last updated
25 Aug 2020
Results posted
No
Data monitoring committee
No
FDA-regulated drug
No
FDA-regulated device
No
Individual data sharing
Undecided

Publications

  • Albers GW, Marks MP, Kemp S, Christensen S, Tsai JP, Ortega-Gutierrez S, McTaggart RA, Torbey MT, Kim-Tenser M, Leslie-Mazwi T, Sarraj A, Kasner SE, Ansari SA, Yeatts SD, Hamilton S, Mlynash M, Heit JJ, Zaharchuk G, Kim S, Carrozzella J, Palesch YY, Demchuk AM, Bammer R, Lavori PW, Broderick JP, Lansberg MG; DEFUSE 3 Investigators. Thrombectomy for Stroke at 6 to 16 Hours with Selection by Perfusion Imaging. N Engl J Med. 2018 Feb 22;378(8):708-718. doi: 10.1056/NEJMoa1713973. Epub 2018 Jan 24.

    PubMed 29364767
  • Carmichael ST, Kathirvelu B, Schweppe CA, Nie EH. Molecular, cellular and functional events in axonal sprouting after stroke. Exp Neurol. 2017 Jan;287(Pt 3):384-394. doi: 10.1016/j.expneurol.2016.02.007. Epub 2016 Feb 10.

    PubMed 26874223
  • Cortes JC, Goldsmith J, Harran MD, Xu J, Kim N, Schambra HM, Luft AR, Celnik P, Krakauer JW, Kitago T. A Short and Distinct Time Window for Recovery of Arm Motor Control Early After Stroke Revealed With a Global Measure of Trajectory Kinematics. Neurorehabil Neural Repair. 2017 Jun;31(6):552-560. doi: 10.1177/1545968317697034. Epub 2017 Mar 16.

    PubMed 28506149
  • El Amki M, Wegener S. Improving Cerebral Blood Flow after Arterial Recanalization: A Novel Therapeutic Strategy in Stroke. Int J Mol Sci. 2017 Dec 9;18(12):2669. doi: 10.3390/ijms18122669.

    PubMed 29232823
  • Goyal M, Menon BK, van Zwam WH, Dippel DW, Mitchell PJ, Demchuk AM, Davalos A, Majoie CB, van der Lugt A, de Miquel MA, Donnan GA, Roos YB, Bonafe A, Jahan R, Diener HC, van den Berg LA, Levy EI, Berkhemer OA, Pereira VM, Rempel J, Millan M, Davis SM, Roy D, Thornton J, Roman LS, Ribo M, Beumer D, Stouch B, Brown S, Campbell BC, van Oostenbrugge RJ, Saver JL, Hill MD, Jovin TG; HERMES collaborators. Endovascular thrombectomy after large-vessel ischaemic stroke: a meta-analysis of individual patient data from five randomised trials. Lancet. 2016 Apr 23;387(10029):1723-31. doi: 10.1016/S0140-6736(16)00163-X. Epub 2016 Feb 18.

    PubMed 26898852
  • Ginsberg MD. Expanding the concept of neuroprotection for acute ischemic stroke: The pivotal roles of reperfusion and the collateral circulation. Prog Neurobiol. 2016 Oct-Nov;145-146:46-77. doi: 10.1016/j.pneurobio.2016.09.002. Epub 2016 Sep 13.

    PubMed 27637159
  • Mostany R, Chowdhury TG, Johnston DG, Portonovo SA, Carmichael ST, Portera-Cailliau C. Local hemodynamics dictate long-term dendritic plasticity in peri-infarct cortex. J Neurosci. 2010 Oct 20;30(42):14116-26. doi: 10.1523/JNEUROSCI.3908-10.2010.

    PubMed 20962232
  • Nogueira RG, Jadhav AP, Haussen DC, Bonafe A, Budzik RF, Bhuva P, Yavagal DR, Ribo M, Cognard C, Hanel RA, Sila CA, Hassan AE, Millan M, Levy EI, Mitchell P, Chen M, English JD, Shah QA, Silver FL, Pereira VM, Mehta BP, Baxter BW, Abraham MG, Cardona P, Veznedaroglu E, Hellinger FR, Feng L, Kirmani JF, Lopes DK, Jankowitz BT, Frankel MR, Costalat V, Vora NA, Yoo AJ, Malik AM, Furlan AJ, Rubiera M, Aghaebrahim A, Olivot JM, Tekle WG, Shields R, Graves T, Lewis RJ, Smith WS, Liebeskind DS, Saver JL, Jovin TG; DAWN Trial Investigators. Thrombectomy 6 to 24 Hours after Stroke with a Mismatch between Deficit and Infarct. N Engl J Med. 2018 Jan 4;378(1):11-21. doi: 10.1056/NEJMoa1706442. Epub 2017 Nov 11.

    PubMed 29129157
  • Wahl AS, Omlor W, Rubio JC, Chen JL, Zheng H, Schroter A, Gullo M, Weinmann O, Kobayashi K, Helmchen F, Ommer B, Schwab ME. Neuronal repair. Asynchronous therapy restores motor control by rewiring of the rat corticospinal tract after stroke. Science. 2014 Jun 13;344(6189):1250-5. doi: 10.1126/science.1253050.

    PubMed 24926013
  • Dufour JP, Inauen C, Hobner L, Bellomo J, Schubert T, Sebok M, Fierstra J, Colombo E, van Niftrik CHB, Piccirelli M, Globas C, Kulcsar Z, Luft A, Wegener S, Regli L, Esposito G. Serial Intracranial Flow Rate Measurements Using Quantitative Magnetic Resonance Angiography Following Large-Vessel Occlusion Stroke. Brain Sci. 2026 Jan 31;16(2):171. doi: 10.3390/brainsci16020171.

    PubMed 41750172
  • Barbagallo M, Zahn M, Zimmermann J, Klovekorn R, Held J, Nemeth B, Reolon B, Bellomo J, Schwarz A, Veerbeek JM, Van Niftrik CHB, Sebok M, Piccirelli M, Michels L, Luft AR, Kulcsar Z, Regli L, Esposito G, Fierstra J, Thurner P, Schubert T, Wegener S. Reperfusion failure after successful thrombectomy of large vessel occlusion stroke: clinical and imaging evidence. Front Neurol. 2025 Aug 22;16:1639880. doi: 10.3389/fneur.2025.1639880. eCollection 2025.

    PubMed 40917674

Questions about this trial

What is this clinical trial studying?

An observational study of Stroke, Ischemic, run by University of Zurich at 1 site in Switzerland.

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 5 inclusion and 5 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: status not confirmed, as of the sponsor's last update on 25 Aug 2020. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 1 site in Switzerland. 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?

Results are not available in the source record.

How can a doctor refer a patient or contact the research team?

Contact Andreas R Luft, Prof. MD (+41 (0)44 255 54 00, andreas.luft@uzh.ch), or a site near the patient. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Change in brain microcirculation (time frame: <72 hours; 7, 45 and 90 days after stroke onset). 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?

On the ClinicalTrials.gov record for NCT04035746, which also lists 11 linked publications.

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 25 Aug 2020.

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