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Trial record 3 of 4 for:    26898852 [PUBMED-IDS]

Microcirculation and Plasticity After Stroke (IMPreST)

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ClinicalTrials.gov Identifier: NCT04035746
Recruitment Status : Not yet recruiting
First Posted : July 29, 2019
Last Update Posted : July 29, 2019
Sponsor:
Information provided by (Responsible Party):
University of Zurich

Brief 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. 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.


Condition or disease Intervention/treatment
Stroke, Ischemic Other: Observation of microcirculation and plasticity of the brain

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Study Type : Observational
Estimated Enrollment : 49 participants
Observational Model: Cohort
Time Perspective: Prospective
Official Title: The Interplay of Microcirculation and Plasticity After Ischemic Stroke
Estimated Study Start Date : August 1, 2019
Estimated Primary Completion Date : January 31, 2022
Estimated Study Completion Date : January 31, 2022

Group/Cohort Intervention/treatment
Single-group study
Assessment of microcirculation, brain plasticity and clinical function
Other: Observation of microcirculation and plasticity of the brain
Assessment of microcirculation, brain plasticity and clinical function




Primary Outcome Measures :
  1. Change in brain microcirculation [ Time Frame: <36 and 50 hours; 7, 45 and 90 days after stroke onset ]
    Change in microcirculation of the brain as measured by magnetic resonance imaging (MRI)

  2. Change in brain plasticity [ Time Frame: 7, 45 and 90 days after stroke onset ]
    Change in plasticity of the brain as measured by transcranial magnetic stimulation (TMS)


Secondary Outcome Measures :
  1. National Institutes of Health Stroke Scale [ Time Frame: <36 and 50 hours; 7, 45 and 90 days after stroke onset ]
    Neurological impairments (scale range 0-42, higher values represent a worse outcome)

  2. Fugl-Meyer Motor Assessment - Upper Extremity Subscale [ Time Frame: 50 hours; 7, 45 and 90 days after stroke onset ]
    Upper limb motor function (scale range 0-66, higher values represent a better outcome)

  3. Fugl-Meyer Motor Assessment - Lower Extremity Subscale [ Time Frame: 50 hours; 7, 45 and 90 days after stroke onset ]
    Lower limb motor function (scale range 0-34, higher values represent a better outcome)

  4. Finger extension 1 [ Time Frame: <36 and 50 hours; 7, 45 and 90 days after stroke onset ]
    Ability to extend the fingers (scale range 0-2, higher values represent a better outcome)

  5. Finger extension 2 [ Time Frame: <36 and 50 hours; 7, 45 and 90 days after stroke onset ]
    Ability to extend the fingers (scale range 0-10, higher values represent a better outcome)

  6. Finger extension 3 [ Time Frame: <36 and 50 hours; 7, 45 and 90 days after stroke onset ]
    Ability to extend the fingers (scale range 0-3, higher values represent a worse outcome)

  7. Trunk Control Test [ Time Frame: 50 hours; 7 and 90 days after stroke onset ]
    Trunk ability (scale range 0-100, higher values represent a better outcome)

  8. Functional Ambulation Categories [ Time Frame: <36 and 50 hours; 7, 45 and 90 days after stroke onset ]
    Walking ability (independence) (scale range 0-5, higher values represent a better outcome)

  9. Ten-Meter Walk Test [ Time Frame: 7, 45 and 90 days after stroke onset ]
    Gait speed and cadence (scale range is time in seconds, higher values represent a worse outcome)

  10. Modified Rankin Scale [ Time Frame: <36 and 50 hours; 7, 45 and 90 days after stroke onset ]
    Global disability (scale range 0-5, higher values represent a worse outcome)

  11. Mobilization [ Time Frame: <36 and 50 hours; 7 days ]
    Amount of mobilization (scale range is time in minutes, higher values represent a better outcome)

  12. Concomitant movement therapy [ Time Frame: <36 and 50 hours; 7, 45 and 90 days after stroke onset ]
    Intensity of therapy based on charts (scale range is time in minutes, higher values represent a better outcome)

  13. Related Serious Events [ Time Frame: <36 and 50 hours; 7, 45 and 90 days after stroke onset ]
    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)



Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Sampling Method:   Probability Sample
Study Population
Consecutively admitted to the hospital
Criteria

Inclusion Criteria:

  • ≤36h First-ever clinical ischemic stroke at hospital admission
  • Occlusion of M1-segment of the middle cerebral artery, and/ or intracranial internal carotid artery
  • 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

Exclusion Criteria:

  • 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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT04035746


Contacts
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Contact: Janne M Veerbeek, PhD +41 (0)43 253 01 54 janne.veerbeek@uzh.ch
Contact: Jeremia PO Held, PhD +41 (0)44 255 56 45 jeremia.held@uzh.ch

Sponsors and Collaborators
University of Zurich
Investigators
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Study Chair: Andreas R Luft, Prof. MD University of Zurich, University Hospital Zurich

Publications:

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Responsible Party: University of Zurich
ClinicalTrials.gov Identifier: NCT04035746     History of Changes
Other Study ID Numbers: BASEC-Nr. 2019-00750
First Posted: July 29, 2019    Key Record Dates
Last Update Posted: July 29, 2019
Last Verified: July 2019
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: Undecided

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
Keywords provided by University of Zurich:
Microcirculation
Plasticity
Cohort studies
Additional relevant MeSH terms:
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Stroke
Ischemia
Cerebrovascular Disorders
Brain Diseases
Central Nervous System Diseases
Nervous System Diseases
Vascular Diseases
Cardiovascular Diseases
Pathologic Processes