Sevoflurane In Acute Myocardial Infarction

Acute Myocardial Infarction Clinical Trial

— SIAMI  

Official title:

Sevoflurane Sedation During Primary Percutaneous Coronary Intervention.

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT00971607
• Other study ID #: R-09-165
• Secondary ID: 15793
• Status: Completed
• Phase: Phase 2
• First received: July 9, 2009
• Last updated: September 8, 2014
• Start date: May 2009
• Est. completion date: December 2013

Study information

• Verified date: September 2014
• Source: Lawson Health Research Institute
• Contact: n/a
• Is FDA regulated: No
• Health authority: Canada: Ethics Review Committee
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 50
• Est. completion date: December 2013
• Est. primary completion date: December 2013
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 18 Years to 75 Years

Eligibility

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

Study Design

Allocation: Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Parallel Assignment, Masking: Double Blind (Subject, Caregiver, Investigator, Outcomes Assessor), Primary Purpose: Treatment

Related Conditions & MeSH terms

• Acute Myocardial Infarction
• Infarction
• Myocardial Infarction

Intervention

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

Locations

Country	Name	City	State
Canada	London Health Sceinces Centre	London	Ontario

Sponsors (1)

Lead Sponsor	Collaborator
Lawson Health Research Institute

Country where clinical trial is conducted

Canada, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Infarct size by area under the curve of cardiac markers.		3 days	No
Secondary	Left ventricular function.		Six month	No
Secondary	ST segment elevation resolution		90 minutes	No
Secondary	TIMI flow		60 minutes	No
Secondary	Renal function		48 hours	Yes
Secondary	CRP		24 hours	No
Secondary	Patient satisfaction		1 hour	No