<clinical_study>
  <!-- This xml conforms to an XML Schema at:
    https://clinicaltrials.gov/ct2/html/images/info/public.xsd -->
  <required_header>
    <download_date>ClinicalTrials.gov processed this data on September 20, 2023</download_date>
    <link_text>Link to the current ClinicalTrials.gov record.</link_text>
    <url>https://clinicaltrials.gov/ct2/show/NCT03264742</url>
  </required_header>
  <id_info>
    <org_study_id>ID 2017-00387</org_study_id>
    <nct_id>NCT03264742</nct_id>
  </id_info>
  <brief_title>Ghrelintrial With Patients With Stroke</brief_title>
  <official_title>Longitudinal Trial to Investigate a Neuroprotective Effect of Ghrelin After Acute Ischemic Stroke</official_title>
  <sponsors>
    <lead_sponsor>
      <agency>Kantonsspital Winterthur KSW</agency>
      <agency_class>Other</agency_class>
    </lead_sponsor>
  </sponsors>
  <source>Kantonsspital Winterthur KSW</source>
  <oversight_info>
    <has_dmc>Yes</has_dmc>
    <is_fda_regulated_drug>No</is_fda_regulated_drug>
    <is_fda_regulated_device>No</is_fda_regulated_device>
  </oversight_info>
  <brief_summary>
    <textblock>
      Patients are assigned to KSW's Stroke Unit as part of the emergency treatment. There the&#xD;
      patients are included in the study and treated according to the concept on the Stroke Unit&#xD;
      within the complex treatment. The patients are included after clarification and with the&#xD;
      consent of the patients. On the morning after the day of intake, the first determination of&#xD;
      the ghrelin takes place in the routine blood sampling. Similarly, 48 hours later and 3 months&#xD;
      after the stroke, a blood sampling is performed to determine ghrelin. The De Morton Mobility&#xD;
      Index (DEMMI), the 9-hole-peg assay and the modified Rankin Scale (mRS) are determined on the&#xD;
      day of admission, on the 3rd day, and three months after stroke. This is done within the&#xD;
      framework of the routine clarification and treatment on the Stroke Unit.&#xD;
    </textblock>
  </brief_summary>
  <detailed_description>
    <textblock>
      Ghreline is a peptide hormone which is produced particularly by cells of the stomach mucous&#xD;
      membrane and has an appetizing effect. Nevertheless, the last studies in the person as well&#xD;
      as in the animal model showed that ghreline as well as receptos of ghreline become exprimated&#xD;
      also in neurons. Antiapoptic effects of ghreline, an increase of the endogenous neuro genesis&#xD;
      and support of the formation of dendritic synapses could be proved. In a study in the animal&#xD;
      model (rats), for example, a neuroprotective effect from ghreline could be proved. Besides,&#xD;
      ghreline showed neuro-regenerative effects after a stroke. As a possible mechanism an&#xD;
      increased neuro genesis is accepted for this. Now the aim of our study is to be examined&#xD;
      whether the patients with an ischemic stroke who have a high ghreline concentration have a&#xD;
      better functional outcome. No interventions specific for study take place. It concerns with&#xD;
      this research project not a clinical attempt, but a pure blood withdrawal plus survey.&#xD;
      Besides, no special risks exist for the patient, because it is found in the routine treatment&#xD;
      on the stroke station (Stroke Unit) of the canton hospital of Winterthur and no measures&#xD;
      specific for study are carried out.&#xD;
&#xD;
      aims of Project: The aim of this study is to examine Ghrelin concerning his neuroprotective&#xD;
      and neuro-regenerative improvement of patients with acute stroke.&#xD;
&#xD;
      Aim dimensions of the project Improvement of the functional Outcomes with patients with acute&#xD;
      stroke measured in the De Morton Mobility Index (DEMMI), 9hole-peg-Test and the modified&#xD;
      Rankin-Scale (mRS) in relation to the ghreline-serum concentration. In the morning after the&#xD;
      admission day the decrease of the first Ghrelintest occurs within the scope of the blood&#xD;
      sample as a matter of routine to be carried out. Also 48 hours later and 3 months after the&#xD;
      blow attack a blood sample for testing the ghreline concentration is taken as a mater of&#xD;
      routine.&#xD;
&#xD;
      The patients are recruited within the scope of the treatment on the stroke station of the&#xD;
      canton hospital of Winterthur Duration of the project 2 Years intended time of the beginning&#xD;
      of the project (FPFV): 01/09/2016 prospective time of the end of the project (LPLV):&#xD;
      31/08/2018 The Stroke Unit (stroke station) of the canton hospital of Winterthur exists since&#xD;
      01.04. 2013 and looks meanwhile yearly after more than 400 patients with cerebrovaskulären&#xD;
      illnesses. To the-chance a qualified and experienced nursing staff stands beside the medical&#xD;
      care, neuro-logically experienced therapists as well as a suitable infrastructure which&#xD;
      enables to raise the data necessary for the study qualitatively on the highest level&#xD;
    </textblock>
  </detailed_description>
  <overall_status>Terminated</overall_status>
  <why_stopped>
    recruitment too low&#xD;
  </why_stopped>
  <start_date type="Actual">April 1, 2017</start_date>
  <completion_date type="Actual">February 28, 2019</completion_date>
  <primary_completion_date type="Actual">February 28, 2019</primary_completion_date>
  <study_type>Observational</study_type>
  <has_expanded_access>No</has_expanded_access>
  <study_design_info>
    <observational_model>Cohort</observational_model>
    <time_perspective>Prospective</time_perspective>
  </study_design_info>
  <primary_outcome>
    <measure>De Morton Mobility Index (DEMMI)</measure>
    <time_frame>On the first, the third day and 3 months after including in the study, the time for the DEMMI takes about 20 minutes</time_frame>
    <description>The de Morton Mobility Index (DEMMI) is an internationally well-established, unidimensional measure of mobility with good psychometric properties.</description>
  </primary_outcome>
  <enrollment type="Actual">6</enrollment>
  <condition>DEMMMI, Nine-Hole-PEG-Test, mRS</condition>
  <condition>Stroke, Acute</condition>
  <intervention>
    <intervention_type>Other</intervention_type>
    <intervention_name>Ghrelin</intervention_name>
    <description>The patients are assigned within the scope of the admission according to emergency to the treatment and clarification on the Stroke Unit of the KSW. There the patients are enclosed in the study and are examined according to the draught on the Stroke Unit within the scope of the complex treatment. The inclusion of the patients occurs after clarification and in the consent of the patients. In the morning after the admission day the decrease of the first blood test occurs within the scope of the blood sample as a matter of routine to be carried out for the Ghrelinbestimmung. Also 48 H occurs after the first withdrawal and 3 months after the stroke a blood sample to the regulation of Ghrelin.</description>
  </intervention>
  <eligibility>
    <study_pop>
      <textblock>
        Male and female patients with acute ischemic insult with functionally relevant motor&#xD;
        Hemisymptomatik up to 7 days after the event at the age from 18 to 90 years with written&#xD;
        approval of the participant after occurred clarification&#xD;
      </textblock>
    </study_pop>
    <sampling_method>Probability Sample</sampling_method>
    <criteria>
      <textblock>
        Inclusion Criteria:&#xD;
&#xD;
          -  Male and female patients&#xD;
&#xD;
          -  acute ischemic insult&#xD;
&#xD;
          -  functionally relevant motor hemisymptomatic&#xD;
&#xD;
          -  up to 7 days after the event&#xD;
&#xD;
          -  age from 18 to 90 years&#xD;
&#xD;
          -  written approval of the participant after occurred clarification&#xD;
&#xD;
        Exclusion Criteria:&#xD;
&#xD;
          -  Dysphagia&#xD;
&#xD;
          -  Nutritional-Risk-Screening (NRS) = 3&#xD;
&#xD;
          -  Neuro-degenerative illnesses&#xD;
&#xD;
          -  Patients with strokes in the past&#xD;
&#xD;
          -  Patients with clinically relevant Polyneuropathy&#xD;
&#xD;
          -  Patients with walking disturbance on account of mikroangiopathic changes&#xD;
&#xD;
          -  Patients with psychiatric preillnesses (depression, schizophrenia) and anti-&#xD;
             depressive and neuroleptic medication&#xD;
&#xD;
          -  Patients with rheumatic illnesses with effects on the walking and Hand function&#xD;
&#xD;
          -  Patients with innate and/or acquired substance defects of the brain and/or spinal cord&#xD;
             (functionally relevant brain tumour, St. n. Encephalitis, brain damage as an infant)&#xD;
      </textblock>
    </criteria>
    <gender>All</gender>
    <minimum_age>18 Years</minimum_age>
    <maximum_age>90 Years</maximum_age>
    <healthy_volunteers>No</healthy_volunteers>
  </eligibility>
  <overall_official>
    <last_name>Peter Ballmer</last_name>
    <role>Principal Investigator</role>
    <affiliation>Kantonsspital Winterthur KSW</affiliation>
  </overall_official>
  <location>
    <facility>
      <name>Kantonsspital Winterthur</name>
      <address>
        <city>Winterthur</city>
        <zip>8400</zip>
        <country>Switzerland</country>
      </address>
    </facility>
  </location>
  <location_countries>
    <country>Switzerland</country>
  </location_countries>
  <reference>
    <citation>Cummings DE. Ghrelin and the short- and long-term regulation of appetite and body weight. Physiol Behav. 2006 Aug 30;89(1):71-84. doi: 10.1016/j.physbeh.2006.05.022. Epub 2006 Jul 21.</citation>
    <PMID>16859720</PMID>
  </reference>
  <reference>
    <citation>Spencer SJ, Miller AA, Andrews ZB. The role of ghrelin in neuroprotection after ischemic brain injury. Brain Sci. 2013 Mar 19;3(1):344-59. doi: 10.3390/brainsci3010344.</citation>
    <PMID>24961317</PMID>
  </reference>
  <verification_date>February 2019</verification_date>
  <study_first_submitted>August 17, 2017</study_first_submitted>
  <study_first_submitted_qc>August 24, 2017</study_first_submitted_qc>
  <study_first_posted type="Actual">August 29, 2017</study_first_posted>
  <last_update_submitted>February 28, 2019</last_update_submitted>
  <last_update_submitted_qc>February 28, 2019</last_update_submitted_qc>
  <last_update_posted type="Actual">March 1, 2019</last_update_posted>
  <responsible_party>
    <responsible_party_type>Sponsor</responsible_party_type>
  </responsible_party>
  <keyword>ghreline, stroke</keyword>
  <condition_browse>
    <!-- CAUTION:  The following MeSH terms are assigned with an imperfect algorithm            -->
    <mesh_term>Stroke</mesh_term>
  </condition_browse>
  <patient_data>
    <sharing_ipd>Undecided</sharing_ipd>
  </patient_data>
  <!-- Results have not yet been posted for this study                                          -->
</clinical_study>


download date: ClinicalTrials.gov processed this data on September 20, 2023
link text: Link to the current ClinicalTrials.gov record.
url: https://clinicaltrials.gov/ct2/show/NCT03264742
org study id: ID 2017-00387
nct id: NCT03264742
lead sponsor: 
has dmc: Yes
is fda regulated drug: No
is fda regulated device: No
Patients are assigned to KSW's Stroke Unit as part of the emergency treatment. There the
      patients are included in the study and treated according to the concept on the Stroke Unit
      within the complex treatment. The patients are included after clarification and with the
      consent of the patients. On the morning after the day of intake, the first determination of
      the ghrelin takes place in the routine blood sampling. Similarly, 48 hours later and 3 months
      after the stroke, a blood sampling is performed to determine ghrelin. The De Morton Mobility
      Index (DEMMI), the 9-hole-peg assay and the modified Rankin Scale (mRS) are determined on the
      day of admission, on the 3rd day, and three months after stroke. This is done within the
      framework of the routine clarification and treatment on the Stroke Unit.
Ghreline is a peptide hormone which is produced particularly by cells of the stomach mucous
      membrane and has an appetizing effect. Nevertheless, the last studies in the person as well
      as in the animal model showed that ghreline as well as receptos of ghreline become exprimated
      also in neurons. Antiapoptic effects of ghreline, an increase of the endogenous neuro genesis
      and support of the formation of dendritic synapses could be proved. In a study in the animal
      model (rats), for example, a neuroprotective effect from ghreline could be proved. Besides,
      ghreline showed neuro-regenerative effects after a stroke. As a possible mechanism an
      increased neuro genesis is accepted for this. Now the aim of our study is to be examined
      whether the patients with an ischemic stroke who have a high ghreline concentration have a
      better functional outcome. No interventions specific for study take place. It concerns with
      this research project not a clinical attempt, but a pure blood withdrawal plus survey.
      Besides, no special risks exist for the patient, because it is found in the routine treatment
      on the stroke station (Stroke Unit) of the canton hospital of Winterthur and no measures
      specific for study are carried out.

      aims of Project: The aim of this study is to examine Ghrelin concerning his neuroprotective
      and neuro-regenerative improvement of patients with acute stroke.

      Aim dimensions of the project Improvement of the functional Outcomes with patients with acute
      stroke measured in the De Morton Mobility Index (DEMMI), 9hole-peg-Test and the modified
      Rankin-Scale (mRS) in relation to the ghreline-serum concentration. In the morning after the
      admission day the decrease of the first Ghrelintest occurs within the scope of the blood
      sample as a matter of routine to be carried out. Also 48 hours later and 3 months after the
      blow attack a blood sample for testing the ghreline concentration is taken as a mater of
      routine.

      The patients are recruited within the scope of the treatment on the stroke station of the
      canton hospital of Winterthur Duration of the project 2 Years intended time of the beginning
      of the project (FPFV): 01/09/2016 prospective time of the end of the project (LPLV):
      31/08/2018 The Stroke Unit (stroke station) of the canton hospital of Winterthur exists since
      01.04. 2013 and looks meanwhile yearly after more than 400 patients with cerebrovaskulären
      illnesses. To the-chance a qualified and experienced nursing staff stands beside the medical
      care, neuro-logically experienced therapists as well as a suitable infrastructure which
      enables to raise the data necessary for the study qualitatively on the highest level
observational model: Cohort
time perspective: Prospective
measure: De Morton Mobility Index (DEMMI)
time frame: On the first, the third day and 3 months after including in the study, the time for the DEMMI takes about 20 minutes
description: The de Morton Mobility Index (DEMMI) is an internationally well-established, unidimensional measure of mobility with good psychometric properties.
intervention type: Other
intervention name: Ghrelin
description: The patients are assigned within the scope of the admission according to emergency to the treatment and clarification on the Stroke Unit of the KSW. There the patients are enclosed in the study and are examined according to the draught on the Stroke Unit within the scope of the complex treatment. The inclusion of the patients occurs after clarification and in the consent of the patients. In the morning after the admission day the decrease of the first blood test occurs within the scope of the blood sample as a matter of routine to be carried out for the Ghrelinbestimmung. Also 48 H occurs after the first withdrawal and 3 months after the stroke a blood sample to the regulation of Ghrelin.
study pop: 
sampling method: Probability Sample
criteria: 
gender: All
minimum age: 18 Years
maximum age: 90 Years
healthy volunteers: No
last name: Peter Ballmer
role: Principal Investigator
affiliation: Kantonsspital Winterthur KSW
facility: 
country: Switzerland
citation: Cummings DE. Ghrelin and the short- and long-term regulation of appetite and body weight. Physiol Behav. 2006 Aug 30;89(1):71-84. doi: 10.1016/j.physbeh.2006.05.022. Epub 2006 Jul 21.
PMID: 16859720
citation: Spencer SJ, Miller AA, Andrews ZB. The role of ghrelin in neuroprotection after ischemic brain injury. Brain Sci. 2013 Mar 19;3(1):344-59. doi: 10.3390/brainsci3010344.
PMID: 24961317
responsible party type: Sponsor
mesh term: Stroke
sharing ipd: Undecided