<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/NCT03001635</url>
  </required_header>
  <id_info>
    <org_study_id>2629-15-SMC</org_study_id>
    <nct_id>NCT03001635</nct_id>
  </id_info>
  <brief_title>Role of Oxytocin in Myocardial Infarction</brief_title>
  <official_title>The Impact of Oxytocin Administration on Short and Long Term Prognosis in Patients Undergoing ST Elevation Myocardial Infarction</official_title>
  <sponsors>
    <lead_sponsor>
      <agency>Sheba Medical Center</agency>
      <agency_class>Other</agency_class>
    </lead_sponsor>
  </sponsors>
  <source>Sheba Medical Center</source>
  <oversight_info>
    <has_dmc>Yes</has_dmc>
  </oversight_info>
  <brief_summary>
    <textblock>
      60 patients admitted to this ICCU at the Sheba medical Center will be randomly divided in to&#xD;
      2 groups. one group will receive the conventional treatment while the second group will&#xD;
      receive the conventional treatment plus oxytocin infusion for 48 hours. all participants will&#xD;
      undergo echo and cMRI during hospitalization.&#xD;
    </textblock>
  </brief_summary>
  <overall_status>Unknown status</overall_status>
  <last_known_status>Not yet recruiting</last_known_status>
  <start_date>January 2017</start_date>
  <primary_completion_date type="Anticipated">December 2018</primary_completion_date>
  <phase>Phase 2/Phase 3</phase>
  <study_type>Interventional</study_type>
  <has_expanded_access>No</has_expanded_access>
  <study_design_info>
    <allocation>Randomized</allocation>
    <intervention_model>Parallel Assignment</intervention_model>
    <primary_purpose>Treatment</primary_purpose>
    <masking>Single (Participant)</masking>
  </study_design_info>
  <primary_outcome>
    <measure>final infarction size</measure>
    <time_frame>1 week</time_frame>
    <description>all patients will undergo an cMRI after 7 days</description>
  </primary_outcome>
  <secondary_outcome>
    <measure>Ejection fraction</measure>
    <time_frame>48 hours</time_frame>
    <description>all patients will undergo echocardiography exam during the first 48 hours</description>
  </secondary_outcome>
  <other_outcome>
    <measure>number on events with ventricular arrythmia</measure>
    <time_frame>48 hours</time_frame>
    <description>all patients will be continually monitored for ventricular arrhythmia</description>
  </other_outcome>
  <number_of_arms>2</number_of_arms>
  <enrollment type="Anticipated">52</enrollment>
  <condition>Myocardial Infarction</condition>
  <arm_group>
    <arm_group_label>conventional treatment and oxytocin</arm_group_label>
    <arm_group_type>Experimental</arm_group_type>
    <description>26 patients admitted to the ICCU under a diagnosis of STEMI will receive treatment with oxytocin as an add on to the conventional treatment (e.g. primary PCI, aspirin, ADP receptor inhibitors, high dose statin, beta blockers &amp; ACE inhibitors). At admission, a continuance infusion with oxytocin will be initiated for a time period of 6 hours. 10 units of oxytocin will be diluted in 1 liter of 0.9% normal saline. the infusion will start at a rate of 2.5 milliunits/min. dosage will be increased at a rate of 5 milliuinits/min every 30 min if there are no side effect, up to a maximum dosage of 30 milliunits/min.</description>
  </arm_group>
  <arm_group>
    <arm_group_label>conventional treatment only</arm_group_label>
    <arm_group_type>Placebo Comparator</arm_group_type>
    <description>26 patients admitted to the ICCU under a diagnosis of STEMI will receive the conventional treatment (e.g. primary PCI, aspirin, ADP receptor inhibitors, high dose statin, beta blockers &amp; ACE inhibitors). On admission, an infusion of 0.9 normal saline will be stared as placebo.</description>
  </arm_group>
  <intervention>
    <intervention_type>Drug</intervention_type>
    <intervention_name>Oxytocin</intervention_name>
    <description>26 patients will receive Oxytocin infusion for 6h while 26 will receive placebo. all other treatments will be the same and up to date with the current guidelines.</description>
    <arm_group_label>conventional treatment and oxytocin</arm_group_label>
    <other_name>Pitocin</other_name>
  </intervention>
  <intervention>
    <intervention_type>Drug</intervention_type>
    <intervention_name>Placebos</intervention_name>
    <description>26 patients will receive 0.9% normal saline infusion for 6h as placebo</description>
    <arm_group_label>conventional treatment only</arm_group_label>
  </intervention>
  <eligibility>
    <criteria>
      <textblock>
        Inclusion Criteria:&#xD;
&#xD;
          -  age &gt; 18 years&#xD;
&#xD;
          -  current diagnosis of ST elevation myocardial infarction&#xD;
&#xD;
          -  no previous episodes of acute coronary syndrome&#xD;
&#xD;
          -  agreed to enter research&#xD;
&#xD;
        Exclusion Criteria:&#xD;
&#xD;
          -  age &lt; 18 years&#xD;
&#xD;
          -  congestive heart failure (acute or chronic)&#xD;
&#xD;
          -  cardiomyopathy&#xD;
&#xD;
          -  life threatening arrhythmia at presentation&#xD;
&#xD;
          -  previous LV dysfunction&#xD;
&#xD;
          -  hypotension (systolic &lt; 100mmHg, diastolic&lt;50mmHg, 15% less than patients normal&#xD;
             values)&#xD;
&#xD;
          -  tachycardia - pulse &gt; 100bpm&#xD;
&#xD;
          -  bradycardia - pulse &lt; 55 ppm&#xD;
&#xD;
          -  killip 3 or 4 at presentation&#xD;
&#xD;
          -  current use of nitrates&#xD;
&#xD;
          -  pregnancy&#xD;
&#xD;
          -  females - history of pathological GU bleeding&#xD;
&#xD;
          -  inability to give consent&#xD;
      </textblock>
    </criteria>
    <gender>All</gender>
    <minimum_age>18 Years</minimum_age>
    <maximum_age>N/A</maximum_age>
    <healthy_volunteers>Accepts Healthy Volunteers</healthy_volunteers>
  </eligibility>
  <overall_official>
    <last_name>Anat Berkovitch, resident</last_name>
    <role>Principal Investigator</role>
    <affiliation>Sheba Medical Center</affiliation>
  </overall_official>
  <overall_contact>
    <last_name>Anat Berkovitch, resident</last_name>
    <phone>972545746277</phone>
    <email>anatberko@gmail.com</email>
  </overall_contact>
  <overall_contact_backup>
    <last_name>Shlomi matetzky, Head of ICCU</last_name>
    <phone>972526667122</phone>
    <email>Shlomi.Matetzky@sheba.health.gov.il</email>
  </overall_contact_backup>
  <results_reference>
    <citation>Robinson KJ, Hazon N, Lonergan M, Pomeroy PP. Validation of an enzyme-linked immunoassay (ELISA) for plasma oxytocin in a novel mammal species reveals potential errors induced by sampling procedure. J Neurosci Methods. 2014 Apr 15;226:73-79. doi: 10.1016/j.jneumeth.2014.01.019. Epub 2014 Jan 28.</citation>
    <PMID>24485867</PMID>
  </results_reference>
  <results_reference>
    <citation>Danalache BA, Paquin J, Donghao W, Grygorczyk R, Moore JC, Mummery CL, Gutkowska J, Jankowski M. Nitric oxide signaling in oxytocin-mediated cardiomyogenesis. Stem Cells. 2007 Mar;25(3):679-88. doi: 10.1634/stemcells.2005-0610. Epub 2006 Nov 30.</citation>
    <PMID>17138963</PMID>
  </results_reference>
  <results_reference>
    <citation>Gutkowska J, Jankowski M. Oxytocin revisited: its role in cardiovascular regulation. J Neuroendocrinol. 2012 Apr;24(4):599-608. doi: 10.1111/j.1365-2826.2011.02235.x.</citation>
    <PMID>21981277</PMID>
  </results_reference>
  <results_reference>
    <citation>Jankowski M, Wang D, Hajjar F, Mukaddam-Daher S, McCann SM, Gutkowska J. Oxytocin and its receptors are synthesized in the rat vasculature. Proc Natl Acad Sci U S A. 2000 May 23;97(11):6207-11. doi: 10.1073/pnas.110137497.</citation>
    <PMID>10811917</PMID>
  </results_reference>
  <results_reference>
    <citation>Alizadeh AM, Faghihi M, Sadeghipour HR, Mohammadghasemi F, Imani A, Houshmand F, Khori V. Oxytocin protects rat heart against ischemia-reperfusion injury via pathway involving mitochondrial ATP-dependent potassium channel. Peptides. 2010 Jul;31(7):1341-5. doi: 10.1016/j.peptides.2010.04.012. Epub 2010 Apr 22.</citation>
    <PMID>20417240</PMID>
  </results_reference>
  <results_reference>
    <citation>Jankowski M, Hajjar F, Kawas SA, Mukaddam-Daher S, Hoffman G, McCann SM, Gutkowska J. Rat heart: a site of oxytocin production and action. Proc Natl Acad Sci U S A. 1998 Nov 24;95(24):14558-63. doi: 10.1073/pnas.95.24.14558.</citation>
    <PMID>9826739</PMID>
  </results_reference>
  <results_reference>
    <citation>Ondrejcakova M, Barancik M, Bartekova M, Ravingerova T, Jezova D. Prolonged oxytocin treatment in rats affects intracellular signaling and induces myocardial protection against infarction. Gen Physiol Biophys. 2012 Sep;31(3):261-70. doi: 10.4149/gpb_2012_030.</citation>
    <PMID>23047939</PMID>
  </results_reference>
  <results_reference>
    <citation>Jankowski M, Bissonauth V, Gao L, Gangal M, Wang D, Danalache B, Wang Y, Stoyanova E, Cloutier G, Blaise G, Gutkowska J. Anti-inflammatory effect of oxytocin in rat myocardial infarction. Basic Res Cardiol. 2010 Mar;105(2):205-18. doi: 10.1007/s00395-009-0076-5. Epub 2009 Dec 12.</citation>
    <PMID>20012748</PMID>
  </results_reference>
  <results_reference>
    <citation>Anvari MA, Imani A, Faghihi M, Karimian SM, Moghimian M, Khansari M. The administration of oxytocin during early reperfusion, dose-dependently protects the isolated male rat heart against ischemia/reperfusion injury. Eur J Pharmacol. 2012 May 5;682(1-3):137-41. doi: 10.1016/j.ejphar.2012.02.029. Epub 2012 Mar 3.</citation>
    <PMID>22406244</PMID>
  </results_reference>
  <results_reference>
    <citation>Authier S, Tanguay JF, Geoffroy P, Gauvin D, Bichot S, Ybarra N, Otis C, Troncy E. Cardiovascular effects of oxytocin infusion in a porcine model of myocardial infarct. J Cardiovasc Pharmacol. 2010 Jan;55(1):74-82. doi: 10.1097/FJC.0b013e3181c5e7d4.</citation>
    <PMID>19858734</PMID>
  </results_reference>
  <verification_date>December 2016</verification_date>
  <study_first_submitted>December 14, 2016</study_first_submitted>
  <study_first_submitted_qc>December 22, 2016</study_first_submitted_qc>
  <study_first_posted type="Estimate">December 23, 2016</study_first_posted>
  <last_update_submitted>December 22, 2016</last_update_submitted>
  <last_update_submitted_qc>December 22, 2016</last_update_submitted_qc>
  <last_update_posted type="Estimate">December 23, 2016</last_update_posted>
  <responsible_party>
    <responsible_party_type>Sponsor</responsible_party_type>
  </responsible_party>
  <condition_browse>
    <!-- CAUTION:  The following MeSH terms are assigned with an imperfect algorithm            -->
    <mesh_term>Myocardial Infarction</mesh_term>
    <mesh_term>Infarction</mesh_term>
  </condition_browse>
  <intervention_browse>
    <!-- CAUTION:  The following MeSH terms are assigned with an imperfect algorithm            -->
    <mesh_term>Oxytocin</mesh_term>
  </intervention_browse>
  <patient_data>
    <sharing_ipd>No</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/NCT03001635
org study id: 2629-15-SMC
nct id: NCT03001635
lead sponsor: 
has dmc: Yes
60 patients admitted to this ICCU at the Sheba medical Center will be randomly divided in to
      2 groups. one group will receive the conventional treatment while the second group will
      receive the conventional treatment plus oxytocin infusion for 48 hours. all participants will
      undergo echo and cMRI during hospitalization.
allocation: Randomized
intervention model: Parallel Assignment
primary purpose: Treatment
masking: Single (Participant)
measure: final infarction size
time frame: 1 week
description: all patients will undergo an cMRI after 7 days
measure: Ejection fraction
time frame: 48 hours
description: all patients will undergo echocardiography exam during the first 48 hours
measure: number on events with ventricular arrythmia
time frame: 48 hours
description: all patients will be continually monitored for ventricular arrhythmia
arm group label: conventional treatment and oxytocin
arm group type: Experimental
description: 26 patients admitted to the ICCU under a diagnosis of STEMI will receive treatment with oxytocin as an add on to the conventional treatment (e.g. primary PCI, aspirin, ADP receptor inhibitors, high dose statin, beta blockers & ACE inhibitors). At admission, a continuance infusion with oxytocin will be initiated for a time period of 6 hours. 10 units of oxytocin will be diluted in 1 liter of 0.9% normal saline. the infusion will start at a rate of 2.5 milliunits/min. dosage will be increased at a rate of 5 milliuinits/min every 30 min if there are no side effect, up to a maximum dosage of 30 milliunits/min.
arm group label: conventional treatment only
arm group type: Placebo Comparator
description: 26 patients admitted to the ICCU under a diagnosis of STEMI will receive the conventional treatment (e.g. primary PCI, aspirin, ADP receptor inhibitors, high dose statin, beta blockers & ACE inhibitors). On admission, an infusion of 0.9 normal saline will be stared as placebo.
intervention type: Drug
intervention name: Oxytocin
description: 26 patients will receive Oxytocin infusion for 6h while 26 will receive placebo. all other treatments will be the same and up to date with the current guidelines.
arm group label: conventional treatment and oxytocin
other name: Pitocin
intervention type: Drug
intervention name: Placebos
description: 26 patients will receive 0.9% normal saline infusion for 6h as placebo
arm group label: conventional treatment only
criteria: 
gender: All
minimum age: 18 Years
maximum age: N/A
healthy volunteers: Accepts Healthy Volunteers
last name: Anat Berkovitch, resident
role: Principal Investigator
affiliation: Sheba Medical Center
last name: Anat Berkovitch, resident
phone: 972545746277
email: anatberko@gmail.com
last name: Shlomi matetzky, Head of ICCU
phone: 972526667122
email: Shlomi.Matetzky@sheba.health.gov.il
citation: Robinson KJ, Hazon N, Lonergan M, Pomeroy PP. Validation of an enzyme-linked immunoassay (ELISA) for plasma oxytocin in a novel mammal species reveals potential errors induced by sampling procedure. J Neurosci Methods. 2014 Apr 15;226:73-79. doi: 10.1016/j.jneumeth.2014.01.019. Epub 2014 Jan 28.
PMID: 24485867
citation: Danalache BA, Paquin J, Donghao W, Grygorczyk R, Moore JC, Mummery CL, Gutkowska J, Jankowski M. Nitric oxide signaling in oxytocin-mediated cardiomyogenesis. Stem Cells. 2007 Mar;25(3):679-88. doi: 10.1634/stemcells.2005-0610. Epub 2006 Nov 30.
PMID: 17138963
citation: Gutkowska J, Jankowski M. Oxytocin revisited: its role in cardiovascular regulation. J Neuroendocrinol. 2012 Apr;24(4):599-608. doi: 10.1111/j.1365-2826.2011.02235.x.
PMID: 21981277
citation: Jankowski M, Wang D, Hajjar F, Mukaddam-Daher S, McCann SM, Gutkowska J. Oxytocin and its receptors are synthesized in the rat vasculature. Proc Natl Acad Sci U S A. 2000 May 23;97(11):6207-11. doi: 10.1073/pnas.110137497.
PMID: 10811917
citation: Alizadeh AM, Faghihi M, Sadeghipour HR, Mohammadghasemi F, Imani A, Houshmand F, Khori V. Oxytocin protects rat heart against ischemia-reperfusion injury via pathway involving mitochondrial ATP-dependent potassium channel. Peptides. 2010 Jul;31(7):1341-5. doi: 10.1016/j.peptides.2010.04.012. Epub 2010 Apr 22.
PMID: 20417240
citation: Jankowski M, Hajjar F, Kawas SA, Mukaddam-Daher S, Hoffman G, McCann SM, Gutkowska J. Rat heart: a site of oxytocin production and action. Proc Natl Acad Sci U S A. 1998 Nov 24;95(24):14558-63. doi: 10.1073/pnas.95.24.14558.
PMID: 9826739
citation: Ondrejcakova M, Barancik M, Bartekova M, Ravingerova T, Jezova D. Prolonged oxytocin treatment in rats affects intracellular signaling and induces myocardial protection against infarction. Gen Physiol Biophys. 2012 Sep;31(3):261-70. doi: 10.4149/gpb_2012_030.
PMID: 23047939
citation: Jankowski M, Bissonauth V, Gao L, Gangal M, Wang D, Danalache B, Wang Y, Stoyanova E, Cloutier G, Blaise G, Gutkowska J. Anti-inflammatory effect of oxytocin in rat myocardial infarction. Basic Res Cardiol. 2010 Mar;105(2):205-18. doi: 10.1007/s00395-009-0076-5. Epub 2009 Dec 12.
PMID: 20012748
citation: Anvari MA, Imani A, Faghihi M, Karimian SM, Moghimian M, Khansari M. The administration of oxytocin during early reperfusion, dose-dependently protects the isolated male rat heart against ischemia/reperfusion injury. Eur J Pharmacol. 2012 May 5;682(1-3):137-41. doi: 10.1016/j.ejphar.2012.02.029. Epub 2012 Mar 3.
PMID: 22406244
citation: Authier S, Tanguay JF, Geoffroy P, Gauvin D, Bichot S, Ybarra N, Otis C, Troncy E. Cardiovascular effects of oxytocin infusion in a porcine model of myocardial infarct. J Cardiovasc Pharmacol. 2010 Jan;55(1):74-82. doi: 10.1097/FJC.0b013e3181c5e7d4.
PMID: 19858734
responsible party type: Sponsor
mesh term: Myocardial Infarction
mesh term: Infarction
mesh term: Oxytocin
sharing ipd: No