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

This study has been completed.
Sponsor:
Information provided by (Responsible Party):
Shahar Lavi, Lawson Health Research Institute
ClinicalTrials.gov Identifier:
NCT00970827
First received: July 9, 2009
Last updated: September 8, 2014
Last verified: September 2014
  Purpose

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.


Condition Intervention Phase
Coronary Artery Disease
Procedure: remote ischemic postconditioning
Phase 2

Study Type: Interventional
Study Design: Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Double Blind (Caregiver, Outcomes Assessor)
Primary Purpose: Prevention
Official Title: Remote Ischemic Postconditioning During Percutaneous Coronary Interventions.

Further study details as provided by Lawson Health Research Institute:

Primary Outcome Measures:
  • Myocardial injury after PCI. [ Time Frame: 24 hours ] [ Designated as safety issue: No ]

Secondary Outcome Measures:
  • To study the effects of different degrees of remote ischemic postconditioning on myocardial necrosis and inflammation following PCI. [ Time Frame: 24 hours ] [ Designated as safety issue: No ]
  • Platelet function [ Time Frame: 24 hours ] [ Designated as safety issue: No ]
  • Cardiac events [ Time Frame: One year ] [ Designated as safety issue: No ]

Enrollment: 360
Study Start Date: May 2009
Study Completion Date: June 2014
Primary Completion Date: June 2014 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
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).

  Eligibility

Ages Eligible for Study:   18 Years and older
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
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
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT00970827

Locations
Canada, Ontario
London Health Sceinces Centre
London, Ontario, Canada, N6A5A5
Sponsors and Collaborators
Lawson Health Research Institute
Investigators
Principal Investigator: Shahar Lavi, MD Lawson Health Research Institute
  More Information

No publications provided by Lawson Health Research Institute

Additional publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):
Responsible Party: Shahar Lavi, Principal Investigator, Lawson Health Research Institute
ClinicalTrials.gov Identifier: NCT00970827     History of Changes
Other Study ID Numbers: R-09-015, 15664
Study First Received: July 9, 2009
Last Updated: September 8, 2014
Health Authority: Canada: Ethics Review Committee

Keywords provided by Lawson Health Research Institute:
Coronary artery disease
PCI
Postconditioning
Elective or urgent PCI

Additional relevant MeSH terms:
Coronary Artery Disease
Coronary Disease
Myocardial Ischemia
Arterial Occlusive Diseases
Arteriosclerosis
Cardiovascular Diseases
Heart Diseases
Vascular Diseases

ClinicalTrials.gov processed this record on October 20, 2014