Sevoflurane In Acute Myocardial Infarction

Overview

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.

Full Title of Study: “Sevoflurane Sedation During Primary Percutaneous Coronary Intervention.”

Study Type

• Study Type: Interventional
• Study Design
  • Allocation: Randomized
  • Intervention Model: Parallel Assignment
  • Primary Purpose: Treatment
  • Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
• Study Primary Completion Date: December 2013

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.

Interventions

• Drug: Oxygen + Sevoflurane
  • Oxygen with end-tidal MAC of Sevoflurane 0.5 during PCI.
• Drug: Oxygen (placebo)
  • Control will receive oxygen only.

Arms, Groups and Cohorts

• Active Comparator: 1
  • Sevoflurane
• Placebo Comparator: 2
  • Oxygen

Clinical Trial Outcome Measures

Primary Measures

• Infarct size by area under the curve of cardiac markers.
  • Time Frame: 3 days

Secondary Measures

• Left ventricular function.
  • Time Frame: Six month
• ST segment elevation resolution
  • Time Frame: 90 minutes
• TIMI flow
  • Time Frame: 60 minutes
• Renal function
  • Time Frame: 48 hours
• CRP
  • Time Frame: 24 hours
• Patient satisfaction
  • Time Frame: 1 hour

Participating in This Clinical Trial

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

Gender Eligibility: All

Minimum Age: 18 Years

Maximum Age: 75 Years

Are Healthy Volunteers Accepted: No

Investigator Details

• Lead Sponsor
  • Lawson Health Research Institute
• Provider of Information About this Clinical Study
  • Principal Investigator: Shahar Lavi, Principal Investigator – Lawson Health Research Institute
• Overall Official(s)
  • Shahar Lavi, MD, Principal Investigator, Lawson Health Research Institute