Back to resultsRole of Oxytocin in Myocardial Infarction
Primary Purpose
Myocardial Infarction
Status
Unknown status
Phase
Phase 2
Locations
Study Type
Interventional
Intervention
Oxytocin
Placebos
Sponsored by
About this trial
This is an interventional treatment trial for Myocardial Infarction
Eligibility Criteria
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
Sites / Locations
Arms of the Study
Arm 1
Arm 2
Arm Type
Experimental
Placebo Comparator
Arm Label
conventional treatment and oxytocin
conventional treatment only
Arm 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.
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.
Outcomes
Primary Outcome Measures
final infarction size
all patients will undergo an cMRI after 7 days
Secondary Outcome Measures
Ejection fraction
all patients will undergo echocardiography exam during the first 48 hours
Full Information
NCT ID
NCT03001635
First Posted
December 14, 2016
Last Updated
December 22, 2016
Sponsor
Sheba Medical Center
1. Study Identification
Unique Protocol Identification Number
NCT03001635
Brief Title
Role of Oxytocin in Myocardial Infarction
Official Title
The Impact of Oxytocin Administration on Short and Long Term Prognosis in Patients Undergoing ST Elevation Myocardial Infarction
Study Type
Interventional
2. Study Status
Record Verification Date
December 2016
Overall Recruitment Status
Unknown status
Study Start Date
January 2017 (undefined)
Primary Completion Date
December 2018 (Anticipated)
Study Completion Date
undefined (undefined)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Sheba Medical Center
4. Oversight
Data Monitoring Committee
Yes
5. Study Description
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.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Myocardial Infarction
7. Study Design
Primary Purpose
Treatment
Study Phase
Phase 2, Phase 3
Interventional Study Model
Parallel Assignment
Masking
Participant
Allocation
Randomized
Enrollment
52 (Anticipated)
8. Arms, Groups, and Interventions
Arm Title
conventional treatment and oxytocin
Arm Type
Experimental
Arm 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.
Arm Title
conventional treatment only
Arm Type
Placebo Comparator
Arm 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.
Intervention Type
Drug
Intervention Name(s)
Oxytocin
Other Intervention Name(s)
Pitocin
Intervention Description
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.
Intervention Type
Drug
Intervention Name(s)
Placebos
Intervention Description
26 patients will receive 0.9% normal saline infusion for 6h as placebo
Primary Outcome Measure Information:
Title
final infarction size
Description
all patients will undergo an cMRI after 7 days
Time Frame
1 week
Secondary Outcome Measure Information:
Title
Ejection fraction
Description
all patients will undergo echocardiography exam during the first 48 hours
Time Frame
48 hours
Other Pre-specified Outcome Measures:
Title
number on events with ventricular arrythmia
Description
all patients will be continually monitored for ventricular arrhythmia
Time Frame
48 hours
10. Eligibility
Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
Accepts Healthy Volunteers
Eligibility Criteria
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
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Anat Berkovitch, resident
Phone
972545746277
Email
anatberko@gmail.com
First Name & Middle Initial & Last Name or Official Title & Degree
Shlomi matetzky, Head of ICCU
Phone
972526667122
Email
Shlomi.Matetzky@sheba.health.gov.il
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Anat Berkovitch, resident
Organizational Affiliation
Sheba Medical Center
Official's Role
Principal Investigator
12. IPD Sharing Statement
Plan to Share IPD
No
Citations:
PubMed Identifier
24485867
Citation
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Citation
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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.
Results Reference
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PubMed Identifier
10811917
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. doi: 10.1073/pnas.110137497.
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Citation
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PubMed Identifier
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Citation
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PubMed Identifier
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Citation
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Results Reference
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PubMed Identifier
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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/s00395-009-0076-5. Epub 2009 Dec 12.
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Citation
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Citation
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Role of Oxytocin in Myocardial Infarction
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