Role of Oxytocin in Myocardial Infarction

Sheba Medical Center

Status and phase: Unknown; Phase 3; Phase 2

Conditions: Myocardial Infarction

Treatments: Drug: Placebos; Drug: Oxytocin

Study type: Interventional

Funder types: Other

Identifiers

NCT03001635

2629-15-SMC

Details and patient eligibility

About

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.

Enrollment: 52 estimated patients

Sex: All

Ages: 18+ years old

Volunteers: Accepts Healthy Volunteers

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

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Single Blind

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52 participants in 2 patient groups, including a placebo group

conventional treatment and oxytocin

Experimental group

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.

Treatment:

Drug: Oxytocin

conventional treatment only

Placebo Comparator group

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.

Treatment:

Drug: Placebos