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Sevoflurane In Acute Myocardial Infarction (SIAMI)

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

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.

Condition or disease Intervention/treatment Phase
Acute Myocardial Infarction Drug: Oxygen + Sevoflurane Drug: Oxygen (placebo) Phase 2

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.

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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 50 participants
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.
Study Start Date : May 2009
Actual Primary Completion Date : December 2013
Actual Study Completion Date : December 2013

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Heart Attack
Drug Information available for: Sevoflurane

Arm Intervention/treatment
Active Comparator: 1
Drug: Oxygen + Sevoflurane
Oxygen with end-tidal MAC of Sevoflurane 0.5 during PCI.

Placebo Comparator: 2
Drug: Oxygen (placebo)
Control will receive oxygen only.

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

Secondary Outcome Measures :
  1. Left ventricular function. [ Time Frame: Six month ]
  2. ST segment elevation resolution [ Time Frame: 90 minutes ]
  3. TIMI flow [ Time Frame: 60 minutes ]
  4. Renal function [ Time Frame: 48 hours ]
  5. CRP [ Time Frame: 24 hours ]
  6. Patient satisfaction [ Time Frame: 1 hour ]

Information from the National Library of Medicine

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

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

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 identifier (NCT number): NCT00971607

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

Publications automatically indexed to this study by Identifier (NCT Number):
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Responsible Party: Shahar Lavi, Principal Investigator, Lawson Health Research Institute Identifier: NCT00971607     History of Changes
Other Study ID Numbers: R-09-165
15793 ( Other Identifier: REB )
First Posted: September 3, 2009    Key Record Dates
Last Update Posted: September 9, 2014
Last Verified: September 2014
Keywords provided by Shahar Lavi, Lawson Health Research Institute:
Acute myocardial infarction
Additional relevant MeSH terms:
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Myocardial Infarction
Pathologic Processes
Myocardial Ischemia
Heart Diseases
Cardiovascular Diseases
Vascular Diseases
Platelet Aggregation Inhibitors
Anesthetics, Inhalation
Anesthetics, General
Central Nervous System Depressants
Physiological Effects of Drugs