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OpenTrials
Completed

NCT Number: NCT00971607

Sevoflurane In Acute Myocardial Infarction

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.

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Key information

Conditions

Acute Myocardial Infarction

Age range

18 year–75 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 2

Primary location

London Health Sceinces Centre

London, Ontario, N6A5A5, Canada

About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Oxygen + Sevoflurane

Drug

Oxygen with end-tidal MAC of Sevoflurane 0.5 during PCI.

Oxygen (placebo)

Drug

Control will receive oxygen only.

Primary outcomes

  1. Infarct size by area under the curve of cardiac markers.

    Time frame: 3 days

Secondary outcomes

  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

Sponsors and collaborators

Lead sponsor

London Health Sciences Centre Research Institute OR Lawson Research Institute of St. Joseph's

Other

Registry information

Official study title

Sevoflurane Sedation During Primary Percutaneous Coronary Intervention.

Acronym: SIAMI

Important dates

Study start
2009
Primary completion
2013
Study completion
2013
First posted
Sep 3, 2009
Registry last updated
Sep 9, 2014

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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