Remote Ischemic Postconditioning During Percutaneous Coronary Interventions (RIP-PCI)

Lawson Health Research Institute

Status and phase: Completed; Phase 2

Conditions: Coronary Artery Disease

Treatments: Procedure: remote ischemic postconditioning

Study type: Interventional

Funder types: Other

Identifiers

NCT00970827

15664 (Other Identifier)

R-09-015

Details and patient eligibility

About

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.

Enrollment: 360 patients

Sex: All

Ages: 18+ years old

Volunteers: No Healthy Volunteers

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

Trial design

Primary purpose: Prevention

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Double Blind

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360 participants in 3 patient groups, including a placebo group

1

Active Comparator group

Description:

Leg postconditioning

Treatment:

Procedure: remote ischemic postconditioning

2

Active Comparator group

Description:

Arm postconditioning

Treatment:

Procedure: remote ischemic postconditioning

3

Placebo Comparator group

Description:

Control group

Treatment:

Procedure: remote ischemic postconditioning