Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
Get a concise snapshot of the trial, including recruitment status, study phase, enrollment targets, and key timeline milestones.
UNKNOWN
PHASE2/PHASE3
52 participants
INTERVENTIONAL
2017-01-31
Brief Summary
Review the sponsor-provided synopsis that highlights what the study is about and why it is being conducted.
Detailed Description
Dive into the extended narrative that explains the scientific background, objectives, and procedures in greater depth.
Conditions
See the medical conditions and disease areas that this research is targeting or investigating.
Study Design
Understand how the trial is structured, including allocation methods, masking strategies, primary purpose, and other design elements.
RANDOMIZED
PARALLEL
TREATMENT
SINGLE
Study Groups
Review each arm or cohort in the study, along with the interventions and objectives associated with them.
conventional treatment and oxytocin
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.
Oxytocin
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.
conventional treatment only
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.
Placebos
26 patients will receive 0.9% normal saline infusion for 6h as placebo
Interventions
Learn about the drugs, procedures, or behavioral strategies being tested and how they are applied within this trial.
Oxytocin
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.
Placebos
26 patients will receive 0.9% normal saline infusion for 6h as placebo
Other Intervention Names
Discover alternative or legacy names that may be used to describe the listed interventions across different sources.
Eligibility Criteria
Check the participation requirements, including inclusion and exclusion rules, age limits, and whether healthy volunteers are accepted.
Inclusion Criteria
* current diagnosis of ST elevation myocardial infarction
* no previous episodes of acute coronary syndrome
* agreed to enter research
Exclusion Criteria
* 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
18 Years
ALL
Yes
Sponsors
Meet the organizations funding or collaborating on the study and learn about their roles.
Sheba Medical Center
OTHER_GOV
Responsible Party
Identify the individual or organization who holds primary responsibility for the study information submitted to regulators.
Principal Investigators
Learn about the lead researchers overseeing the trial and their institutional affiliations.
Anat Berkovitch, resident
Role: PRINCIPAL_INVESTIGATOR
Sheba Medical Center
Central Contacts
Reach out to these primary contacts for questions about participation or study logistics.
References
Explore related publications, articles, or registry entries linked to this study.
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.
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.
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.
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.
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.
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.
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.
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.
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.
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.
Other Identifiers
Review additional registry numbers or institutional identifiers associated with this trial.
2629-15-SMC
Identifier Type: -
Identifier Source: org_study_id