Sevoflurane In Acute Myocardial Infarction (SIAMI)
Primary Purpose
Acute Myocardial Infarction
Status
Completed
Phase
Phase 2
Locations
Canada
Study Type
Interventional
Intervention
Oxygen + Sevoflurane
Oxygen (placebo)
Sponsored by
About this trial
This is an interventional treatment trial for Acute Myocardial Infarction focused on measuring Acute myocardial infarction, Postconditioning, Sevoflurane
Eligibility 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
Sites / Locations
- London Health Sceinces Centre
Arms of the Study
Arm 1
Arm 2
Arm Type
Active Comparator
Placebo Comparator
Arm Label
1
2
Arm Description
Sevoflurane
Oxygen
Outcomes
Primary Outcome Measures
Infarct size by area under the curve of cardiac markers.
Secondary Outcome Measures
Left ventricular function.
ST segment elevation resolution
TIMI flow
Renal function
CRP
Patient satisfaction
Full Information
NCT ID
NCT00971607
First Posted
July 9, 2009
Last Updated
September 8, 2014
Sponsor
Lawson Health Research Institute
1. Study Identification
Unique Protocol Identification Number
NCT00971607
Brief Title
Sevoflurane In Acute Myocardial Infarction
Acronym
SIAMI
Official Title
Sevoflurane Sedation During Primary Percutaneous Coronary Intervention.
Study Type
Interventional
2. Study Status
Record Verification Date
September 2014
Overall Recruitment Status
Completed
Study Start Date
May 2009 (undefined)
Primary Completion Date
December 2013 (Actual)
Study Completion Date
December 2013 (Actual)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Lawson Health Research Institute
4. Oversight
Data Monitoring Committee
No
5. Study Description
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.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Acute Myocardial Infarction
Keywords
Acute myocardial infarction, Postconditioning, Sevoflurane
7. Study Design
Primary Purpose
Treatment
Study Phase
Phase 2
Interventional Study Model
Parallel Assignment
Masking
ParticipantCare ProviderInvestigatorOutcomes Assessor
Allocation
Randomized
Enrollment
50 (Actual)
8. Arms, Groups, and Interventions
Arm Title
1
Arm Type
Active Comparator
Arm Description
Sevoflurane
Arm Title
2
Arm Type
Placebo Comparator
Arm Description
Oxygen
Intervention Type
Drug
Intervention Name(s)
Oxygen + Sevoflurane
Intervention Description
Oxygen with end-tidal MAC of Sevoflurane 0.5 during PCI.
Intervention Type
Drug
Intervention Name(s)
Oxygen (placebo)
Intervention Description
Control will receive oxygen only.
Primary Outcome Measure Information:
Title
Infarct size by area under the curve of cardiac markers.
Time Frame
3 days
Secondary Outcome Measure Information:
Title
Left ventricular function.
Time Frame
Six month
Title
ST segment elevation resolution
Time Frame
90 minutes
Title
TIMI flow
Time Frame
60 minutes
Title
Renal function
Time Frame
48 hours
Title
CRP
Time Frame
24 hours
Title
Patient satisfaction
Time Frame
1 hour
10. Eligibility
Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
75 Years
Accepts Healthy Volunteers
No
Eligibility 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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Shahar Lavi, MD
Organizational Affiliation
Lawson Health Research Institute
Official's Role
Principal Investigator
Facility Information:
Facility Name
London Health Sceinces Centre
City
London
State/Province
Ontario
ZIP/Postal Code
N6A5A5
Country
Canada
12. IPD Sharing Statement
Citations:
PubMed Identifier
26296299
Citation
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.
Results Reference
derived
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Sevoflurane In Acute Myocardial Infarction
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