Role of Oxytocin in Myocardial Infarction

Study Overview
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Brief Summary
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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.

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

Conditions
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Myocardial Infarction

Intervention / Treatment
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* Drug: Oxytocin
* Drug: Placebos


Participation Criteria
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Eligibility Criteria
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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

Ages Eligible for Study
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Minimum Age: 18 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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Accepts Healthy Volunteers

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Single


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: conventional treatment and oxytocin<br>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<br>* 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.<br>* Other names: Pitocin;|
| Placebo Comparator: conventional treatment only<br>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<br>* 26 patients will receive 0.9% normal saline infusion for 6h as placebo<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| final infarction size | all patients will undergo an cMRI after 7 days | 1 week | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Ejection fraction | all patients will undergo echocardiography exam during the first 48 hours | 48 hours |