Remote Ischemic Postconditioning During Percutaneous Coronary Interventions

Overview

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.

Full Title of Study: “Remote Ischemic Postconditioning During Percutaneous Coronary Interventions.”

Study Type

  • Study Type: Interventional
  • Study Design
    • Allocation: Randomized
    • Intervention Model: Parallel Assignment
    • Primary Purpose: Prevention
    • Masking: Double (Care Provider, Outcomes Assessor)
  • Study Primary Completion Date: June 2014

Interventions

  • 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).

Arms, Groups and Cohorts

  • Active Comparator: 1
    • Leg postconditioning
  • Active Comparator: 2
    • Arm postconditioning
  • Placebo Comparator: 3
    • Control group

Clinical Trial Outcome Measures

Primary Measures

  • Myocardial injury after PCI.
    • Time Frame: 24 hours

Secondary Measures

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

Participating in This Clinical Trial

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

Gender Eligibility: All

Minimum Age: 18 Years

Maximum Age: N/A

Are Healthy Volunteers Accepted: No

Investigator Details

  • Lead Sponsor
    • Lawson Health Research Institute
  • Provider of Information About this Clinical Study
    • Principal Investigator: Shahar Lavi, Principal Investigator – Lawson Health Research Institute
  • Overall Official(s)
    • Shahar Lavi, MD, Principal Investigator, Lawson Health Research Institute

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