Remote Ischemic Postconditioning During Percutaneous Coronary Interventions

Phase 2

Completed

• Conditions: Coronary Artery Disease
• Interventions: Procedure: remote ischemic postconditioning

• Registration Number: NCT00970827
• Lead Sponsor: Lawson Health Research Institute

Brief Summary

Angioplasty is a commonly performed procedure for treating blockage of the blood vessels in the heart. Although this procedure is usually successful, it is often accompanied by a small degree of damage to the heart (i.e., small heart attack).

The purpose of this study is to find out if inflating a blood pressure cuff on the arm or the leg at the time of angioplasty for several minutes has a beneficial effect.

Patients will be assigned to one of three treatment groups: inflating blood pressure cuff on the arm, inflating blood pressure cuff on the leg and a control group.

Detailed Description

Not available

Study Timeline

• Study Start: 2009-05
• Study First Submitted: 2009-07-09
• Study First Submitted QC: 2009-09-02
• Study First Posted: 2009-09-03
• Primary Completion: 2014-06
• Study Completion: 2014-06
• Status Verified: 2014-09
• Last Update Submitted: 2014-09-08
• Last Update Posted: 2014-09-09

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 360

Inclusion Criteria

• Patients scheduled for PCI

Exclusion Criteria

• Acute myocardial infarction
• Myocardial infarction or coronary bypass surgery during the last 4 weeks before PCI
• Use of Glyburide
• Heart failure (NYHA III/IV)
• Chronic inflammatory disease
• Severe renal impairment
• Significant peripheral vascular disease
• Unsuitable for use of an embolic protection device for PCI to SVG

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
2	remote ischemic postconditioning	Arm postconditioning
3	remote ischemic postconditioning	Control group
1	remote ischemic postconditioning	Leg postconditioning

Primary Outcome Measures

Name	Time	Method
Myocardial injury after PCI.	24 hours

Secondary Outcome Measures

Name	Time	Method
To study the effects of different degrees of remote ischemic postconditioning on myocardial necrosis and inflammation following PCI.	24 hours
Platelet function	24 hours
Cardiac events	One year

Trial Locations

Locations (1)

London Health Sceinces Centre; 🇨🇦 London, Ontario, Canada