Remote Ischemic Postconditioning During Percutaneous Coronary Interventions

Coronary Artery Disease Clinical Trial

— RIP-PCI  

Official title:

Remote Ischemic Postconditioning During Percutaneous Coronary Interventions.

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT00970827
• Other study ID #: R-09-015
• Secondary ID: 15664
• Status: Completed
• Phase: Phase 2
• First received: July 9, 2009
• Last updated: September 8, 2014
• Start date: May 2009
• Est. completion date: June 2014

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

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 360
• Est. completion date: June 2014
• Est. primary completion date: June 2014
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 18 Years and older

Eligibility

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

Allocation: Randomized, Intervention Model: Parallel Assignment, Masking: Double Blind (Caregiver, Outcomes Assessor), Primary Purpose: Prevention

Related Conditions & MeSH terms

• Coronary Artery Disease
• Coronary Disease
• Myocardial Ischemia

Intervention

Procedure:
• remote ischemic postconditioning
Three 5- minute cycles of blood pressure cuff inflation according to the assigned group. The cuff is inflated to 200 mm Hg (and at least 20 mmHg above the systolic blood pressure) for 5 minutes followed by a 5-minute deflation (reperfusion).

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	Myocardial injury after PCI.		24 hours	No
Secondary	To study the effects of different degrees of remote ischemic postconditioning on myocardial necrosis and inflammation following PCI.		24 hours	No
Secondary	Platelet function		24 hours	No
Secondary	Cardiac events		One year	No