- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT00971607
Sevoflurane In Acute Myocardial Infarction (SIAMI)
September 8, 2014 updated by: Shahar Lavi, Lawson Health Research Institute
Sevoflurane Sedation During Primary Percutaneous Coronary Intervention.
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.
Study Overview
Status
Completed
Conditions
Intervention / Treatment
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
Interventional
Enrollment (Actual)
50
Phase
- Phase 2
Contacts and Locations
This section provides the contact details for those conducting the study, and information on where this study is being conducted.
Study Locations
-
-
Ontario
-
London, Ontario, Canada, N6A5A5
- London Health Sceinces Centre
-
-
Participation Criteria
Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.
Eligibility Criteria
Ages Eligible for Study
18 years to 75 years (Adult, Older Adult)
Accepts Healthy Volunteers
No
Genders Eligible for Study
All
Description
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
Study Plan
This section provides details of the study plan, including how the study is designed and what the study is measuring.
How is the study designed?
Design Details
- Primary Purpose: Treatment
- Allocation: Randomized
- Interventional Model: Parallel Assignment
- Masking: Quadruple
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
---|---|
Active Comparator: 1
Sevoflurane
|
Oxygen with end-tidal MAC of Sevoflurane 0.5 during PCI.
|
Placebo Comparator: 2
Oxygen
|
Control will receive oxygen only.
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Time Frame |
---|---|
Infarct size by area under the curve of cardiac markers.
Time Frame: 3 days
|
3 days
|
Secondary Outcome Measures
Outcome Measure |
Time Frame |
---|---|
Left ventricular function.
Time Frame: Six month
|
Six month
|
ST segment elevation resolution
Time Frame: 90 minutes
|
90 minutes
|
TIMI flow
Time Frame: 60 minutes
|
60 minutes
|
Renal function
Time Frame: 48 hours
|
48 hours
|
CRP
Time Frame: 24 hours
|
24 hours
|
Patient satisfaction
Time Frame: 1 hour
|
1 hour
|
Collaborators and Investigators
This is where you will find people and organizations involved with this study.
Sponsor
Investigators
- Principal Investigator: Shahar Lavi, MD, Lawson Health Research Institute
Publications and helpful links
The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.
Study record dates
These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.
Study Major Dates
Study Start
May 1, 2009
Primary Completion (Actual)
December 1, 2013
Study Completion (Actual)
December 1, 2013
Study Registration Dates
First Submitted
July 9, 2009
First Submitted That Met QC Criteria
September 2, 2009
First Posted (Estimate)
September 3, 2009
Study Record Updates
Last Update Posted (Estimate)
September 9, 2014
Last Update Submitted That Met QC Criteria
September 8, 2014
Last Verified
September 1, 2014
More Information
Terms related to this study
Additional Relevant MeSH Terms
- Ischemia
- Pathologic Processes
- Necrosis
- Myocardial Ischemia
- Heart Diseases
- Cardiovascular Diseases
- Vascular Diseases
- Myocardial Infarction
- Infarction
- Physiological Effects of Drugs
- Central Nervous System Depressants
- Anesthetics, General
- Anesthetics
- Platelet Aggregation Inhibitors
- Anesthetics, Inhalation
- Sevoflurane
Other Study ID Numbers
- R-09-165
- 15793 (Other Identifier: REB)
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
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Chang, Steve S., M.D.Santa Barbara Cottage HospitalCompletedPostoperative AbscessUnited States
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Princess Margaret Hospital for ChildrenCompleted
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