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Sevoflurane In Acute Myocardial Infarction (SIAMI)

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ClinicalTrials.gov Identifier: NCT00971607
Recruitment Status : Completed
First Posted : September 3, 2009
Last Update Posted : September 9, 2014
Sponsor:
Information provided by (Responsible Party):
Shahar Lavi, Lawson Health Research Institute

Tracking Information
First Submitted Date  ICMJE July 9, 2009
First Posted Date  ICMJE September 3, 2009
Last Update Posted Date September 9, 2014
Study Start Date  ICMJE May 2009
Actual Primary Completion Date December 2013   (Final data collection date for primary outcome measure)
Current Primary Outcome Measures  ICMJE
 (submitted: September 2, 2009)
Infarct size by area under the curve of cardiac markers. [ Time Frame: 3 days ]
Original Primary Outcome Measures  ICMJE Same as current
Change History Complete list of historical versions of study NCT00971607 on ClinicalTrials.gov Archive Site
Current Secondary Outcome Measures  ICMJE
 (submitted: September 2, 2009)
  • Left ventricular function. [ Time Frame: Six month ]
  • ST segment elevation resolution [ Time Frame: 90 minutes ]
  • TIMI flow [ Time Frame: 60 minutes ]
  • Renal function [ Time Frame: 48 hours ]
  • CRP [ Time Frame: 24 hours ]
  • Patient satisfaction [ Time Frame: 1 hour ]
Original Secondary Outcome Measures  ICMJE Same as current
Current Other Pre-specified Outcome Measures Not Provided
Original Other Pre-specified Outcome Measures Not Provided
 
Descriptive Information
Brief Title  ICMJE Sevoflurane In Acute Myocardial Infarction
Official Title  ICMJE Sevoflurane Sedation During Primary Percutaneous Coronary Intervention.
Brief Summary

Ischemic postconditioning can reduce myocardial injury following myocardial infarction.

A potential pharmacological agent is the anesthetic Sevoflurane. The investigators' hypothesis is that sevoflurane during primary percutaneous coronary intervention (PCI) will reduce infarct size.

Detailed Description Patients with first STEMI that will be treated by primary PCI, will be randomized to sedation with Sevoflurane during the procedure or to usual care.
Study Type  ICMJE Interventional
Study Phase  ICMJE Phase 2
Study Design  ICMJE Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Primary Purpose: Treatment
Condition  ICMJE Acute Myocardial Infarction
Intervention  ICMJE
  • Drug: Oxygen + Sevoflurane
    Oxygen with end-tidal MAC of Sevoflurane 0.5 during PCI.
  • Drug: Oxygen (placebo)
    Control will receive oxygen only.
Study Arms  ICMJE
  • Active Comparator: 1
    Sevoflurane
    Intervention: Drug: Oxygen + Sevoflurane
  • Placebo Comparator: 2
    Oxygen
    Intervention: Drug: Oxygen (placebo)
Publications * Lavi S, Alemayehu M, McCarty D, Warrington J, Lavi R. One-year outcome of the sevoflurane in acute myocardial infarction randomized trial. Can J Anaesth. 2015 Dec;62(12):1279-86. doi: 10.1007/s12630-015-0456-2. Epub 2015 Aug 22.

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruitment Information
Recruitment Status  ICMJE Completed
Actual Enrollment  ICMJE
 (submitted: September 2, 2009)
50
Original Estimated Enrollment  ICMJE Same as current
Actual Study Completion Date  ICMJE December 2013
Actual Primary Completion Date December 2013   (Final data collection date for primary outcome measure)
Eligibility Criteria  ICMJE

Inclusion Criteria:

  • First STEMI, presenting within 6 hours after the onset of chest pain
  • Symptoms lasting > 30 minutes
  • Persistent ST-segment elevation > 0.1 mV in 2 or more contiguous leads

Exclusion Criteria:

  • Hypersensitivity to sevoflurane or other halogenated agents
  • Malignant hyperthermia
  • Cardiac arrest
  • Cardiogenic shock
  • Previous myocardial infarction or coronary bypass surgery
  • Pre-infarction angina
  • Heart failure (NYHA III/IV)
  • Chronic inflammatory disease
  • Severe renal impairment
  • Hepatic dysfunction
  • Use of Glyburide
Sex/Gender  ICMJE
Sexes Eligible for Study: All
Ages  ICMJE 18 Years to 75 Years   (Adult, Older Adult)
Accepts Healthy Volunteers  ICMJE No
Contacts  ICMJE Contact information is only displayed when the study is recruiting subjects
Listed Location Countries  ICMJE Canada
Removed Location Countries  
 
Administrative Information
NCT Number  ICMJE NCT00971607
Other Study ID Numbers  ICMJE R-09-165
15793 ( Other Identifier: REB )
Has Data Monitoring Committee No
U.S. FDA-regulated Product Not Provided
IPD Sharing Statement  ICMJE Not Provided
Responsible Party Shahar Lavi, Lawson Health Research Institute
Study Sponsor  ICMJE Lawson Health Research Institute
Collaborators  ICMJE Not Provided
Investigators  ICMJE
Principal Investigator: Shahar Lavi, MD Lawson Health Research Institute
PRS Account Lawson Health Research Institute
Verification Date September 2014

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP