MedPath

Role of Oxytocin in Myocardial Infarction

Phase 2
Conditions
Myocardial Infarction
Interventions
Drug: Placebos
Registration Number
NCT03001635
Lead Sponsor
Sheba Medical Center
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.

Detailed Description

Not available

Recruitment & Eligibility

Status
UNKNOWN
Sex
All
Target Recruitment
52
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

Study Type
INTERVENTIONAL
Study Design
PARALLEL
Arm && Interventions
GroupInterventionDescription
conventional treatment onlyPlacebos26 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.
conventional treatment and oxytocinOxytocin26 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.
Primary Outcome Measures
NameTimeMethod
final infarction size1 week

all patients will undergo an cMRI after 7 days

Secondary Outcome Measures
NameTimeMethod
Ejection fraction48 hours

all patients will undergo echocardiography exam during the first 48 hours

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