Sevoflurane In Acute Myocardial Infarction (SIAMI)

This study has been completed.
Sponsor:
Information provided by (Responsible Party):
Shahar Lavi, Lawson Health Research Institute
ClinicalTrials.gov Identifier:
NCT00971607
First received: July 9, 2009
Last updated: September 8, 2014
Last verified: September 2014
  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
Endpoint Classification: Efficacy Study
Intervention Model: Parallel Assignment
Masking: Double Blind (Subject, Caregiver, 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 Lawson Health Research Institute:

Primary Outcome Measures:
  • Infarct size by area under the curve of cardiac markers. [ Time Frame: 3 days ] [ Designated as safety issue: No ]

Secondary Outcome Measures:
  • Left ventricular function. [ Time Frame: Six month ] [ Designated as safety issue: No ]
  • ST segment elevation resolution [ Time Frame: 90 minutes ] [ Designated as safety issue: No ]
  • TIMI flow [ Time Frame: 60 minutes ] [ Designated as safety issue: No ]
  • Renal function [ Time Frame: 48 hours ] [ Designated as safety issue: Yes ]
  • CRP [ Time Frame: 24 hours ] [ Designated as safety issue: No ]
  • Patient satisfaction [ Time Frame: 1 hour ] [ Designated as safety issue: No ]

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

Ages Eligible for Study:   18 Years to 75 Years
Genders Eligible for Study:   Both
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
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: 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

No publications provided

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
Study First Received: July 9, 2009
Last Updated: September 8, 2014
Health Authority: Canada: Ethics Review Committee

Keywords provided by 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
Hematologic Agents
Therapeutic Uses
Pharmacologic Actions
Anesthetics, Inhalation
Anesthetics, General
Anesthetics
Central Nervous System Depressants
Physiological Effects of Drugs
Central Nervous System Agents

ClinicalTrials.gov processed this record on September 30, 2014