NCT03001635

Brief Summary

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.

Trial Health

50
Monitor

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
52

participants targeted

Target at P25-P50 for phase_2

Status
unknown

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

December 14, 2016

Completed
9 days until next milestone

First Posted

Study publicly available on registry

December 23, 2016

Completed
9 days until next milestone

Study Start

First participant enrolled

January 1, 2017

Completed
1.9 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

December 1, 2018

Completed
Last Updated

December 23, 2016

Status Verified

December 1, 2016

Enrollment Period

1.9 years

First QC Date

December 14, 2016

Last Update Submit

December 22, 2016

Conditions

Myocardial Infarction

Outcome Measures

Primary Outcomes (1)

  • final infarction size

    all patients will undergo an cMRI after 7 days

    1 week

Secondary Outcomes (1)

  • Ejection fraction

    48 hours

Other Outcomes (1)

  • number on events with ventricular arrythmia

    48 hours

Study Arms (2)

conventional treatment and oxytocin

EXPERIMENTAL

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.

Drug: Oxytocin

conventional treatment only

PLACEBO COMPARATOR

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.

Drug: Placebos

Interventions

OxytocinDRUG

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.

Also known as: Pitocin
conventional treatment and oxytocin
PlacebosDRUG

26 patients will receive 0.9% normal saline infusion for 6h as placebo

conventional treatment only

Eligibility Criteria

Age18 Years+
Sexall
Healthy VolunteersYes
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • age \> 18 years
  • current diagnosis of ST elevation myocardial infarction
  • no previous episodes of acute coronary syndrome
  • agreed to enter research

You may not qualify if:

  • age \< 18 years
  • congestive heart failure (acute or chronic)
  • cardiomyopathy
  • life threatening arrhythmia at presentation
  • previous LV dysfunction
  • hypotension (systolic \< 100mmHg, diastolic\<50mmHg, 15% less than patients normal values)
  • tachycardia - pulse \> 100bpm
  • bradycardia - pulse \< 55 ppm
  • killip 3 or 4 at presentation
  • current use of nitrates
  • pregnancy
  • females - history of pathological GU bleeding
  • inability to give consent

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Related Publications (10)

  • 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: 24485867RESULT

  • 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: 17138963RESULT

  • 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: 21981277RESULT

  • 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: 10811917RESULT

  • 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: 20417240RESULT

  • 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: 9826739RESULT

  • 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: 23047939RESULT

  • 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: 20012748RESULT

  • 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: 22406244RESULT

  • 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: 19858734RESULT

MeSH Terms

Conditions

Myocardial Infarction

Interventions

Oxytocin

Condition Hierarchy (Ancestors)

Myocardial IschemiaHeart DiseasesCardiovascular DiseasesVascular DiseasesInfarctionIschemiaPathologic ProcessesPathological Conditions, Signs and SymptomsNecrosis

Intervention Hierarchy (Ancestors)

Pituitary Hormones, PosteriorPituitary HormonesPeptide HormonesHormonesHormones, Hormone Substitutes, and Hormone AntagonistsPeptidesAmino Acids, Peptides, and Proteins

Study Officials

  • Anat Berkovitch, resident

    Sheba Medical Center

    PRINCIPAL INVESTIGATOR

Central Study Contacts

Anat Berkovitch, resident

CONTACT

972545746277anatberko@gmail.com

Shlomi matetzky, Head of ICCU

CONTACT

972526667122Shlomi.Matetzky@sheba.health.gov.il

Study Design

Study Type
interventional
Phase
phase 2
Allocation
RANDOMIZED
Masking
SINGLE
Who Masked
PARTICIPANT
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
OTHER GOV
Responsible Party
SPONSOR

Study Record Dates

First Submitted

December 14, 2016

First Posted

December 23, 2016

Study Start

January 1, 2017

Primary Completion

December 1, 2018

Last Updated

December 23, 2016

Record last verified: 2016-12

Data Sharing

IPD Sharing
Will not share