Remote Ischemic Postconditioning During Percutaneous Coronary Interventions

Study Overview
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Brief Summary
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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.

Official Title
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Remote Ischemic Postconditioning During Percutaneous Coronary Interventions.

Conditions
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Coronary Artery Disease

Intervention / Treatment
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* Procedure: remote ischemic postconditioning


Participation Criteria
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Eligibility Criteria
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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

Ages Eligible for Study
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Minimum Age: 18 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Prevention
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Double


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Active Comparator: 1<br>Leg postconditioning | Procedure: remote ischemic postconditioning<br>* 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).<br>|
| Active Comparator: 2<br>Arm postconditioning | Procedure: remote ischemic postconditioning<br>* 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).<br>|
| Placebo Comparator: 3<br>Control group | Procedure: remote ischemic postconditioning<br>* 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).<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Myocardial injury after PCI. |  | 24 hours | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| 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 | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Coronary artery disease, PCI, Postconditioning, Elective or urgent PCI