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

  • Canada
    • 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
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.

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

Lawson Health Research Institute

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.

General Publications

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

Keywords

Additional Relevant MeSH Terms

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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