NCT00971607

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.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
50

participants targeted

Target at P25-P50 for phase_2

Timeline
Completed

Started May 2009

Typical duration for phase_2

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

May 1, 2009

Completed
2 months until next milestone

First Submitted

Initial submission to the registry

July 9, 2009

Completed
2 months until next milestone

First Posted

Study publicly available on registry

September 3, 2009

Completed
4.2 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

December 1, 2013

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

December 1, 2013

Completed
Last Updated

September 9, 2014

Status Verified

September 1, 2014

Enrollment Period

4.6 years

First QC Date

July 9, 2009

Last Update Submit

September 8, 2014

Conditions

Acute Myocardial Infarction

Keywords

Acute myocardial infarctionPostconditioningSevoflurane

Outcome Measures

Primary Outcomes (1)

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

    3 days

Secondary Outcomes (6)

  • Left ventricular function.

    Six month

  • ST segment elevation resolution

    90 minutes

  • TIMI flow

    60 minutes

  • Renal function

    48 hours

  • CRP

    24 hours

  • +1 more secondary outcomes

Study Arms (2)

1

ACTIVE COMPARATOR

Sevoflurane

Drug: Oxygen + Sevoflurane

2

PLACEBO COMPARATOR

Oxygen

Drug: Oxygen (placebo)

Interventions

Oxygen + SevofluraneDRUG

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

1
Oxygen (placebo)DRUG

Control will receive oxygen only.

2

Eligibility Criteria

Age18 Years - 75 Years
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • 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

You may not qualify if:

  • 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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

London Health Sceinces Centre

London, Ontario, N6A5A5, Canada

Location

Related Publications (1)

  • Lavi S, Alemayehu M, McCarty D, Warrington J, Lavi R. One-year outcome of the sevoflurane in acute myocardial infarction randomized trial. Can J Anaesth. 2015 Dec;62(12):1279-86. doi: 10.1007/s12630-015-0456-2. Epub 2015 Aug 22.

    PMID: 26296299DERIVED

MeSH Terms

Interventions

OxygenSevoflurane

Intervention Hierarchy (Ancestors)

ChalcogensElementsInorganic ChemicalsGasesMethyl EthersEthersOrganic ChemicalsHydrocarbons, FluorinatedHydrocarbons, HalogenatedHydrocarbons

Study Officials

  • Shahar Lavi, MD

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

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
phase 2
Allocation
RANDOMIZED
Masking
QUADRUPLE
Who Masked
PARTICIPANT, CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Principal Investigator

Study Record Dates

First Submitted

July 9, 2009

First Posted

September 3, 2009

Study Start

May 1, 2009

Primary Completion

December 1, 2013

Study Completion

December 1, 2013

Last Updated

September 9, 2014

Record last verified: 2014-09

Locations

CA(1)