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

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ClinicalTrials.gov Identifier: NCT00970827
Recruitment Status : Completed
First Posted : September 3, 2009
Last Update Posted : September 9, 2014
Sponsor:
Information provided by (Responsible Party):

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.


Condition or disease Intervention/treatment Phase
Coronary Artery Disease Procedure: remote ischemic postconditioning Phase 2

Study Design

Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 360 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Double (Care Provider, Outcomes Assessor)
Primary Purpose: Prevention
Official Title: Remote Ischemic Postconditioning During Percutaneous Coronary Interventions.
Study Start Date : May 2009
Primary Completion Date : June 2014
Study Completion Date : June 2014
Arms and Interventions

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).


Outcome Measures

Primary Outcome Measures :
  1. Myocardial injury after PCI. [ Time Frame: 24 hours ]

Secondary Outcome Measures :
  1. To study the effects of different degrees of remote ischemic postconditioning on myocardial necrosis and inflammation following PCI. [ Time Frame: 24 hours ]
  2. Platelet function [ Time Frame: 24 hours ]
  3. Cardiac events [ Time Frame: One year ]

Eligibility Criteria

Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years and older   (Adult, Senior)
Sexes Eligible for Study:   All
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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): 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

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 ( Other Identifier: REB )
First Posted: September 3, 2009    Key Record Dates
Last Update Posted: September 9, 2014
Last Verified: September 2014

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

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