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

This study is ongoing, but not recruiting participants.
Sponsor:
Information provided by (Responsible Party):
Shahar Lavi, Lawson Health Research Institute
ClinicalTrials.gov Identifier:
NCT00970827
First received: July 9, 2009
Last updated: July 20, 2013
Last verified: July 2013

July 9, 2009
July 20, 2013
May 2009
June 2014   (final data collection date for primary outcome measure)
Myocardial injury after PCI. [ Time Frame: 24 hours ] [ Designated as safety issue: No ]
Same as current
Complete list of historical versions of study NCT00970827 on ClinicalTrials.gov Archive Site
  • 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 ]
  • 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 ]
  • Endothelial function [ Time Frame: 24 hours ] [ Designated as safety issue: No ]
Not Provided
Not Provided
 
Remote Ischemic Postconditioning During Percutaneous Coronary Interventions
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.

Not Provided
Interventional
Phase 2
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Double Blind (Caregiver, Outcomes Assessor)
Primary Purpose: Prevention
Coronary Artery Disease
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: 1
    Leg postconditioning
    Intervention: Procedure: remote ischemic postconditioning
  • Active Comparator: 2
    Arm postconditioning
    Intervention: Procedure: remote ischemic postconditioning
  • Placebo Comparator: 3
    Control group
    Intervention: Procedure: remote ischemic postconditioning
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.

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Active, not recruiting
360
June 2014
June 2014   (final data collection date for primary outcome measure)

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
Both
18 Years and older
No
Contact information is only displayed when the study is recruiting subjects
Canada
 
NCT00970827
R-09-015, 15664
No
Shahar Lavi, Lawson Health Research Institute
Lawson Health Research Institute
Not Provided
Principal Investigator: Shahar Lavi, MD Lawson Health Research Institute
Lawson Health Research Institute
July 2013

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP