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Sevoflurane In Acute Myocardial Infarction (SIAMI)

This study has been completed.
Sponsor:
ClinicalTrials.gov Identifier:
NCT00971607
First Posted: September 3, 2009
Last Update Posted: September 9, 2014
The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
Information provided by (Responsible Party):
Shahar Lavi, Lawson Health Research Institute
  Purpose

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.


Condition Intervention Phase
Acute Myocardial Infarction Drug: Oxygen + Sevoflurane Drug: Oxygen (placebo) Phase 2

Study Type: Interventional
Study Design: Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Primary Purpose: Treatment
Official Title: Sevoflurane Sedation During Primary Percutaneous Coronary Intervention.

Resource links provided by NLM:


Further study details as provided by Shahar Lavi, Lawson Health Research Institute:

Primary Outcome Measures:
  • Infarct size by area under the curve of cardiac markers. [ Time Frame: 3 days ]

Secondary Outcome Measures:
  • 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 ]

Enrollment: 50
Study Start Date: May 2009
Study Completion Date: December 2013
Primary Completion Date: December 2013 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Active Comparator: 1
Sevoflurane
Drug: Oxygen + Sevoflurane
Oxygen with end-tidal MAC of Sevoflurane 0.5 during PCI.
Placebo Comparator: 2
Oxygen
Drug: Oxygen (placebo)
Control will receive oxygen only.

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.
  Eligibility

Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years to 75 Years   (Adult, Senior)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

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
  Contacts and Locations
Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT00971607


Locations
Canada, Ontario
London Health Sceinces Centre
London, Ontario, Canada, N6A5A5
Sponsors and Collaborators
Lawson Health Research Institute
Investigators
Principal Investigator: Shahar Lavi, MD Lawson Health Research Institute
  More Information

Publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):
Responsible Party: Shahar Lavi, Principal Investigator, Lawson Health Research Institute
ClinicalTrials.gov Identifier: NCT00971607     History of Changes
Other Study ID Numbers: R-09-165
15793 ( Other Identifier: REB )
First Submitted: July 9, 2009
First Posted: September 3, 2009
Last Update Posted: September 9, 2014
Last Verified: September 2014

Keywords provided by Shahar Lavi, Lawson Health Research Institute:
Acute myocardial infarction
Postconditioning
Sevoflurane

Additional relevant MeSH terms:
Infarction
Myocardial Infarction
Ischemia
Pathologic Processes
Necrosis
Myocardial Ischemia
Heart Diseases
Cardiovascular Diseases
Vascular Diseases
Sevoflurane
Platelet Aggregation Inhibitors
Anesthetics, Inhalation
Anesthetics, General
Anesthetics
Central Nervous System Depressants
Physiological Effects of Drugs