Role of Oxytocin in Myocardial Infarction

Myocardial Infarction Clinical Trial

Official title:

The Impact of Oxytocin Administration on Short and Long Term Prognosis in Patients Undergoing ST Elevation Myocardial Infarction

Clinical Trial Details — Status: Not yet recruiting

Administrative data

• NCT number: NCT03001635
• Other study ID #: 2629-15-SMC
• Status: Not yet recruiting
• Phase: Phase 2/Phase 3
• First received: December 14, 2016
• Last updated: December 22, 2016
• Start date: January 2017

Study information

• Verified date: December 2016
• Source: Sheba Medical Center
• Contact: Anat Berkovitch, resident
• Phone: 972545746277
• Email: anatberko[@]gmail.com
• Is FDA regulated: No
• Health authority: Israel: Ministry of Health
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Not yet recruiting
• Enrollment: 52
• Est. primary completion date: December 2018
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: Both
• Age group: 18 Years and older

Eligibility

Inclusion Criteria:

• age > 18 years

• current diagnosis of ST elevation myocardial infarction

• no previous episodes of acute coronary syndrome

• agreed to enter research

Exclusion Criteria:

• 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

Study Design

Allocation: Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Parallel Assignment, Masking: Single Blind (Subject), Primary Purpose: Treatment

Related Conditions & MeSH terms

• Infarction
• Myocardial Infarction

Intervention

Drug:
• 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

Locations

Country	Name	City	State
n/a

Sponsors (1)

Lead Sponsor	Collaborator
Sheba Medical Center

References & Publications (10)

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. — View 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):1 — View 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. — View 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. — View 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. Review. — View 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- — View 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. — View 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. — View 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_ — View 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;226:73-9. doi: 10.1016/j — View Citation

Outcome

Type	Measure	Description	Time frame	Safety issue
Other	number on events with ventricular arrythmia	all patients will be continually monitored for ventricular arrhythmia	48 hours	No
Primary	final infarction size	all patients will undergo an cMRI after 7 days	1 week	No
Secondary	Ejection fraction	all patients will undergo echocardiography exam during the first 48 hours	48 hours	No