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Clinical Trials/NCT00971607
NCT00971607
Completed
Phase 2

Sevoflurane Sedation During Primary Percutaneous Coronary Intervention.

Lawson Health Research Institute1 site in 1 country50 target enrollmentMay 2009
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ConditionsAcute Myocardial Infarction
InterventionsOxygen + SevofluraneOxygen (placebo)

Overview

Phase
Phase 2
Intervention
Oxygen + Sevoflurane
Conditions
Acute Myocardial Infarction
Sponsor
Lawson Health Research Institute
Enrollment
50
Locations
1
Primary Endpoint
Infarct size by area under the curve of cardiac markers.
Status
Completed
Last Updated
11 years ago
OverviewInvestigatorsEligibility CriteriaArms & InterventionsOutcomesSitesSimilar Trials

Overview

Brief Summary

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.

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.

Registry
clinicaltrials.gov
Start Date
May 2009
End Date
December 2013
Last Updated
11 years ago
Study Type
Interventional
Study Design
Parallel
Sex
All

Investigators

Responsible Party
Principal Investigator
Principal Investigator

Shahar Lavi

Principal Investigator

Lawson Health Research Institute

Eligibility 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

Arms & Interventions

1

Sevoflurane

Intervention: Oxygen + Sevoflurane

2

Oxygen

Intervention: Oxygen (placebo)

Outcomes

Primary Outcomes

Infarct size by area under the curve of cardiac markers.

Time Frame: 3 days

Secondary Outcomes

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

Study Sites (1)

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