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

Primary Purpose

Coronary Artery Disease

Status
Completed
Phase
Phase 2
Locations
Canada
Study Type
Interventional
Intervention
remote ischemic postconditioning
Sponsored by
Lawson Health Research Institute
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional prevention trial for Coronary Artery Disease focused on measuring Coronary artery disease, PCI, Postconditioning, Elective or urgent PCI

Eligibility Criteria

18 Years - undefined (Adult, Older Adult)All SexesDoes not accept 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

Sites / Locations

  • London Health Sceinces Centre

Arms of the Study

Arm 1

Arm 2

Arm 3

Arm Type

Active Comparator

Active Comparator

Placebo Comparator

Arm Label

1

2

3

Arm Description

Leg postconditioning

Arm postconditioning

Control group

Outcomes

Primary Outcome Measures

Myocardial injury after PCI.

Secondary Outcome Measures

To study the effects of different degrees of remote ischemic postconditioning on myocardial necrosis and inflammation following PCI.
Platelet function
Cardiac events

Full Information

First Posted
July 9, 2009
Last Updated
September 8, 2014
Sponsor
Lawson Health Research Institute
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1. Study Identification

Unique Protocol Identification Number
NCT00970827
Brief Title
Remote Ischemic Postconditioning During Percutaneous Coronary Interventions
Acronym
RIP-PCI
Official Title
Remote Ischemic Postconditioning During Percutaneous Coronary Interventions.
Study Type
Interventional

2. Study Status

Record Verification Date
September 2014
Overall Recruitment Status
Completed
Study Start Date
May 2009 (undefined)
Primary Completion Date
June 2014 (Actual)
Study Completion Date
June 2014 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Lawson Health Research Institute

4. Oversight

Data Monitoring Committee
No

5. Study Description

Brief 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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Coronary Artery Disease
Keywords
Coronary artery disease, PCI, Postconditioning, Elective or urgent PCI

7. Study Design

Primary Purpose
Prevention
Study Phase
Phase 2
Interventional Study Model
Parallel Assignment
Masking
Care ProviderOutcomes Assessor
Allocation
Randomized
Enrollment
360 (Actual)

8. Arms, Groups, and Interventions

Arm Title
1
Arm Type
Active Comparator
Arm Description
Leg postconditioning
Arm Title
2
Arm Type
Active Comparator
Arm Description
Arm postconditioning
Arm Title
3
Arm Type
Placebo Comparator
Arm Description
Control group
Intervention Type
Procedure
Intervention Name(s)
remote ischemic postconditioning
Intervention Description
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).
Primary Outcome Measure Information:
Title
Myocardial injury after PCI.
Time Frame
24 hours
Secondary Outcome Measure Information:
Title
To study the effects of different degrees of remote ischemic postconditioning on myocardial necrosis and inflammation following PCI.
Time Frame
24 hours
Title
Platelet function
Time Frame
24 hours
Title
Cardiac events
Time Frame
One year

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Shahar Lavi, MD
Organizational Affiliation
Lawson Health Research Institute
Official's Role
Principal Investigator
Facility Information:
Facility Name
London Health Sceinces Centre
City
London
State/Province
Ontario
ZIP/Postal Code
N6A5A5
Country
Canada

12. IPD Sharing Statement

Citations:
PubMed Identifier
28075499
Citation
Lavi S, Abu-Romeh N, Wall S, Alemayehu M, Lavi R. Long-term outcome following remote ischemic postconditioning during percutaneous coronary interventions-the RIP-PCI trial long-term follow-up. Clin Cardiol. 2017 May;40(5):268-274. doi: 10.1002/clc.22668. Epub 2017 Jan 11.
Results Reference
derived
PubMed Identifier
24692535
Citation
Lavi S, D'Alfonso S, Diamantouros P, Camuglia A, Garg P, Teefy P, Jablonsky G, Sridhar K, Lavi R. Remote ischemic postconditioning during percutaneous coronary interventions: remote ischemic postconditioning-percutaneous coronary intervention randomized trial. Circ Cardiovasc Interv. 2014 Apr;7(2):225-32. doi: 10.1161/CIRCINTERVENTIONS.113.000948. Epub 2014 Apr 1.
Results Reference
derived

Learn more about this trial

Remote Ischemic Postconditioning During Percutaneous Coronary Interventions

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