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Myocardial InfarctionPhase 2/3NCT03001635

Role of Oxytocin in Myocardial Infarction

A Phase 2/3 study testing Oxytocin in people with Myocardial Infarction, run by Sheba Medical Center.

Unknown status

Status not confirmed. The sponsor has not verified this record for over two years, so it may be out of date.

Official record
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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. Read more about this study

Who is it for?
Ages 18 years and olderHealthy volunteers can take part
Conditions the study is for
Myocardial Infarction
What is being tested?
Oxytocin
Type of treatment
Injection or infusion
Could I receive a placebo?
Yes, some participants may receive a placebo
How many people
52 participants
Where
No sites listed yet
Study dates
Jan 2017to Dec 2018
Phase
Phase 2/3
Are there results?
None posted in the registry

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

  • Ages 18 years and older
  • All sexes
  • Healthy volunteers accepted
  • Adult, Older adult

Who may be able to join

  • age > 18 years
  • current diagnosis of ST elevation myocardial infarction
  • no previous episodes of acute coronary syndrome
  • agreed to enter research

Who cannot join

  • 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)
Show all 13Show fewer
  • 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 locations and contacts

No sites are listed yet.

Anat Berkovitch, resident contact

972545746277

anatberko@gmail.com

Shlomi matetzky, Head of ICCU contact

972526667122

Shlomi.Matetzky@sheba.health.gov.il

About this study

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

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.

Being tested
Oxytocin, Placebos
Medical subject headings
Myocardial Infarction

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • OxytocinDrug

    Also called Pitocin

    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.

  • PlacebosDrug

    26 patients will receive 0.9% normal saline infusion for 6h as placebo

Study groups in NCT03001635
Study groupRoleWhat they receive
conventional treatment and oxytocinExperimental26 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.
Receives: Drug: Oxytocin
conventional treatment onlyPlacebo comparator26 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.
Receives: Drug: Placebos

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. final infarction size

    all patients will undergo an cMRI after 7 days

    Measured: 1 week

Secondary outcomes (1)

  1. Ejection fraction

    all patients will undergo echocardiography exam during the first 48 hours

    Measured: 48 hours

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted23 Dec 2016 (estimated)
  2. Study startJan 2017
  3. Primary completionDec 2018 (estimated)

Resources

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design
Study type
Interventional
Phase
Phase 2/3
Primary purpose
Treatment
Allocation
Randomised
Intervention model
Parallel groups
Masking
Single blind
Who is masked
Participant
Enrolment
52 participants (estimated)
IDs, dates and publications
ClinicalTrials.gov ID
NCT03001635
Sponsor's protocol ID
2629-15-SMC
Status last verified
Dec 2016
First submitted
14 Dec 2016
Last updated
23 Dec 2016
Results posted
No
Data monitoring committee
Yes
Individual data sharing
No

Publications

  • 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;226:73-79. doi: 10.1016/j.jneumeth.2014.01.019. Epub 2014 Jan 28.

    PubMed 24485867

  • 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. doi: 10.1634/stemcells.2005-0610. Epub 2006 Nov 30.

    PubMed 17138963

  • 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.

    PubMed 21981277

  • 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.

    PubMed 10811917

  • 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. doi: 10.1016/j.peptides.2010.04.012. Epub 2010 Apr 22.

    PubMed 20417240

  • 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. doi: 10.1073/pnas.95.24.14558.

    PubMed 9826739

  • 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_030.

    PubMed 23047939

  • 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.

    PubMed 20012748

  • 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):137-41. doi: 10.1016/j.ejphar.2012.02.029. Epub 2012 Mar 3.

    PubMed 22406244

  • 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.

    PubMed 19858734

Questions about this trial

What is this clinical trial studying?

A Phase 2/3 study testing Oxytocin in people with Myocardial Infarction, run by Sheba Medical Center.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 4 inclusion and 13 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: status not confirmed, as of the sponsor's last update on 23 Dec 2016. Status can change between updates, so confirm with the study contact before making plans.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. Some participants in this study may receive a placebo. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

What does this combined phase mean?

Phase 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.

Phase 3 studies compare the treatment with the current standard treatment or a placebo in a large group, to confirm how well it works and watch for side effects.

Not every study follows the same path, and some studies (observational studies, device studies) have no phase.

Are results available for this study?

Results are not available in the source record.

How can a doctor refer a patient or contact the research team?

Contact Anat Berkovitch, resident (972545746277, anatberko@gmail.com), or a site near the patient. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

final infarction size (time frame: 1 week). It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT03001635, which also lists 10 linked publications.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 23 Dec 2016.

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