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Trial · Interventional

Status unknownPhase 2/3Registry data

Role of Oxytocin in Myocardial Infarction

NCTNCT03001635 (opens ClinicalTrials.gov in a new tab)Other id2629-15-SMC
Open at ClinicalTrials.govAsk about this trial

Overview

Status
Status unknown
Phase
Phase 2/3
Enrollment
52 participants (estimated)
Sponsor
Sheba Medical Center · Other gov
Design
Randomized · Single masking
Countries
Not stated
Start
Jan 2017
Primary completion
Dec 2018 (estimated)
Completion
Not stated
First posted
23 Dec 2016 (estimated)
Last update posted
23 Dec 2016 (estimated)
Conditions
Myocardial Infarction

Timeline

1 trial

  • Completed
  • Ongoing
  • Not yet recruiting
  • Stopped
  • Estimated dates (est.)
  • Results posted
201720182019
  1. Ph 2/3

    Role of Oxytocin in Myocardial Infarction

    NCT03001635

    Jan 2017 to est. Dec 2018 (primary)

Registry summary

Text and fields below are the sponsor's entries at ClinicalTrials.gov, shown as posted.

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.

Interventions

  • OxytocinDrug
  • PlacebosDrug

Arms2

  • Experimental

    conventional treatment and oxytocin

    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.

  • Placebo comparator

    conventional treatment only

    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.

Primary outcomes1

Outcomes the sponsor listed as primary.

  1. final infarction size

    Time frame · 1 week

    Registry description

    all patients will undergo an cMRI after 7 days

Secondary outcomes(1)

  1. Ejection fraction

    Time frame · 48 hours

    Registry description

    all patients will undergo echocardiography exam during the first 48 hours

Posted results

Values are shown as posted at ClinicalTrials.gov, with their units. PepBank has not converted, pooled or compared them.

No results are posted for this trial.

A trial that is still running, or that stopped early, may post results later.

Registry data comes from ClinicalTrials.gov. Study results come from studies, not from the registry. How PepBank works

Studies10

Studies that cite this trial.

Studies with results

1 study on this page

Indexing hint: Observational study · 2000

9 results

Oxytocin and its receptors are synthesized in the rat vasculature.

Jankowski et al. 2000Proceedings of the National Academy of Sciences of the United States of Americacited by 123

PMID 10811917PMC18583DOI 10.1073/pnas.110137497PUB-10811917

Rights unknown9 results
Source linkSee results (9)

More studies

9 studies on this page

Indexing hint: Animal study · 2014

Validation of an enzyme-linked immunoassay (ELISA) for plasma oxytocin in a novel mammal species reveals potential errors induced by sampling procedure.

Robinson et al. 2014Journal of neuroscience methodscited by 39

PMID 24485867DOI 10.1016/j.jneumeth.2014.01.019PUB-24485867

Full text at the publisher
Publisher page

Indexing hint: Review · 2012

Oxytocin revisited: its role in cardiovascular regulation.

Gutkowska et al. 2012Journal of neuroendocrinologycited by 149

PMID 21981277DOI 10.1111/j.1365-2826.2011.02235.xPUB-21981277

Full text at the publisher
Publisher page

Indexing hint: Animal study · 2012

The administration of oxytocin during early reperfusion, dose-dependently protects the isolated male rat heart against ischemia/reperfusion injury.

Anvari et al. 2012European journal of pharmacologycited by 22

PMID 22406244DOI 10.1016/j.ejphar.2012.02.029PUB-22406244

Full text at the publisher
Publisher page

Indexing hint: Animal study · 2012

Prolonged oxytocin treatment in rats affects intracellular signaling and induces myocardial protection against infarction.

Ondrejcakova et al. 2012General physiology and biophysicscited by 22

PMID 23047939DOI 10.4149/gpb_2012_030PUB-23047939

Full text at the publisher
Publisher page

Indexing hint: Animal study · 2010

Cardiovascular effects of oxytocin infusion in a porcine model of myocardial infarct.

Authier et al. 2010Journal of cardiovascular pharmacologycited by 12

PMID 19858734DOI 10.1097/fjc.0b013e3181c5e7d4PUB-19858734

Full text at the publisher
Publisher page

Indexing hint: Animal study · 2010

Anti-inflammatory effect of oxytocin in rat myocardial infarction.

Jankowski et al. 2010Basic research in cardiologycited by 110

PMID 20012748DOI 10.1007/s00395-009-0076-5PUB-20012748

Full text at the publisher
Publisher page

Indexing hint: Animal study · 2010

Oxytocin protects rat heart against ischemia-reperfusion injury via pathway involving mitochondrial ATP-dependent potassium channel.

Alizadeh et al. 2010Peptidescited by 38

PMID 20417240DOI 10.1016/j.peptides.2010.04.012PUB-20417240

Full text at the publisher
Publisher page

PubMed tag: none · 2007

Nitric oxide signaling in oxytocin-mediated cardiomyogenesis.

Danalache et al. 2007Stem cells (Dayton, Ohio)cited by 55

PMID 17138963DOI 10.1634/stemcells.2005-0610PUB-17138963

Rights unknown
Source link

Indexing hint: Animal study · 1998

Rat heart: a site of oxytocin production and action.

Jankowski et al. 1998Proceedings of the National Academy of Sciences of the United States of Americacited by 141

PMID 9826739PMC24412DOI 10.1073/pnas.95.24.14558PUB-09826739

Rights unknown
Source link

Eligibility

Who could join, as posted.

Sex
All
Age
from 18 Years
Healthy volunteers
Accepted
Inclusion and exclusion criteria, as posted
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

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