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

September 8, 2014 updated by: Shahar Lavi, Lawson Health Research Institute

Remote Ischemic Postconditioning During Percutaneous Coronary Interventions.

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.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Study Type

Interventional

Enrollment (Actual)

360

Phase

  • Phase 2

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • Canada
    • Ontario
      • London, Ontario, Canada, N6A5A5
        • London Health Sceinces Centre

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years and older (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

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 Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Prevention
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: Double

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Active Comparator: 1
Leg postconditioning
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).
Active Comparator: 2
Arm postconditioning
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).
Placebo Comparator: 3
Control group
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).

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Time Frame
Myocardial injury after PCI.
Time Frame: 24 hours
24 hours

Secondary Outcome Measures

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

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Lawson Health Research Institute

Investigators

  • Principal Investigator: Shahar Lavi, MD, Lawson Health Research Institute

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

May 1, 2009

Primary Completion (Actual)

June 1, 2014

Study Completion (Actual)

June 1, 2014

Study Registration Dates

First Submitted

July 9, 2009

First Submitted That Met QC Criteria

September 2, 2009

First Posted (Estimate)

September 3, 2009

Study Record Updates

Last Update Posted (Estimate)

September 9, 2014

Last Update Submitted That Met QC Criteria

September 8, 2014

Last Verified

September 1, 2014

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • R-09-015
  • 15664 (Other Identifier: REB)

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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