Sevoflurane In Acute Myocardial Infarction | NCT00971607

Studies
Sevoflurane In Acute Myocardial Infarction

NCT00971607

Sponsor

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

Status

Completed

Last Update Posted

Sep 9, 2014Estimated

Enrollment

50Actual

Phase

Phase 2

Conditions

Acute Myocardial Infarction

Interventions

Oxygen + Sevoflurane
Oxygen (placebo)

Countries

Canada

Protocol Section

Identification Module Status Module Sponsor/Collaborators Module Oversight Module Description Module Conditions Module Design Module Arms/Interventions Module Outcomes Module Eligibility Module Contacts/Locations Module References Module IPD Sharing Statement Module

Results Section

Participant Flow Module Baseline Characteristics Module Outcome Measures Module Adverse Events Module More Info Module

Annotation Section

Annotation Module

Document Section

Large Document Module

Derived Section

Miscellaneous Info Module Condition Browse Module Intervention Browse Module

Protocol Section

Identification Module

NCT ID

Results Section

No data available

No data is available for this block.

Annotation Section

No data available

No data is available for this block.

Document Section

No data available

No data is available for this block.

Derived Section

Miscellaneous Info Module

Version Holder

ID	Type	Description	Link
15793	Other Identifier	REB

Status Module

Record Verification Date

Sep 2014

Overall Recruitment Status or Expanded Access Status

Completed

Last Known Status

Not provided

Delayed Posting

Not provided

Why Stopped

Not provided

Expanded Access Info

Start Date

May 2009

Primary Completion Date

Dec 2013Actual

Completion Date

Dec 2013Actual

First Submitted Date

Jul 9, 2009

First Submission Date that Met QC Criteria

Sep 2, 2009

First Posted Date

Sep 3, 2009Estimated

Results Waived

Not provided

Results First Submitted Date

Not provided

Results First Submitted that Met QC Criteria

Not provided

Results First Posted Date

Not provided

Certification/Extension (aka Delayed Results) First Submitted Date

Not provided

Certification/Extension First Submitted that Passed QC Review

Not provided

Certification/Extension First Posted Date

Not provided

Last Update Submitted Date

Sep 8, 2014

Last Update Posted Date

Sep 9, 2014Estimated

Sponsor/Collaborators Module

Responsible Party, by Official Title

Shahar Lavi, Principal Investigator, London Health Sciences Centre Research Institute OR Lawson Research Institute of St. Joseph'sPrincipal Investigator

Lead Sponsor

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

Collaborators

Not provided

Oversight Module

Has Data Monitoring Committee (DMC)

Is FDA Regulated Drug

Not provided

Is FDA Regulated Device

Not provided

Is Unapproved Device

Not provided

Pediatric Postmarket Surveillance of a Device Product

Not provided

Product Exported from US

Not provided

FDAAA801 Violation

Not provided

Description Module

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.

Design Module

Study Type

Interventional

Number of References to an Expanded Access Study

Not provided

Expanded Access Types

Not provided

Patient Registry

Not provided

Target Follow-Up Duration

Not provided

Phases

Phase 2

Interventional Study Design

Allocation

Biospecimen

No data available

No data is available for this block.

Enrollment

50Actual

Arms/Interventions Module

Arm Groups

Label	Type	Description	Intervention Names
1	Active Comparator	Sevoflurane	Drug: Oxygen + Sevoflurane
2	Placebo Comparator	Oxygen	Drug: Oxygen (placebo)

Interventions

Name	Type	Description	Arm Group Labels	Other Names
Oxygen + Sevoflurane	Drug	Oxygen with end-tidal MAC of Sevoflurane 0.5 during PCI.	1

Outcomes Module

Primary Outcomes

Measure	Description	Time Frame
Infarct size by area under the curve of cardiac markers.		3 days

Secondary Outcomes

Measure	Description	Time Frame
Left ventricular function.		Six month
ST segment elevation resolution		90 minutes
TIMI flow

Other Outcomes

Not provided

Eligibility Module

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
Use of Glyburide

Accepts Healthy Volunteers

Sex

All

Sex/Gender Based

Not provided

Sex/Gender Description

Not provided

Minimum Age

18 Years

Maximum Age

75 Years

Standard Ages

AdultOlder Adult

Study Population

Not provided

Sampling Method

Not provided

Contacts/Locations Module

Central Contacts

Not provided

Overall Officials

Name	Affiliation	Role
Shahar Lavi, MD	London Health Sciences Centre Research Institute OR Lawson Research Institute of St. Joseph's	Principal Investigator

Locations

Facility	Status	City	State	ZIP	Country	Contacts
London Health Sceinces Centre		London	Ontario	N6A5A5	Canada

References Module

Citations

PubMed Identifier	Type	Citation	Retractions
26296299	Derived	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.

ID	Term
D018011	Chalcogens
D004602	Elements
D007287	Inorganic Chemicals
D005740	Gases
D008738