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Completed

NCT Number: NCT00970827

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.

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Key information

Conditions

Coronary Artery Disease Arterial Occlusive Diseases Arteriosclerosis Cardiovascular Diseases Coronary Disease Heart Diseases Myocardial Ischemia Vascular Diseases

Age range

18 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 2

Primary location

London Health Sceinces Centre

London, Ontario, N6A5A5, Canada

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Remote ischemic postconditioning

Procedure

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 outcomes

  1. Myocardial injury after PCI.

    Time frame: 24 hours

Secondary outcomes

  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

Sponsors and collaborators

Lead sponsor

London Health Sciences Centre Research Institute OR Lawson Research Institute of St. Joseph's

Other

Registry information

Official study title

Remote Ischemic Postconditioning During Percutaneous Coronary Interventions.

Acronym: RIP-PCI

Important dates

Study start
2009
Primary completion
2014
Study completion
2014
First posted
Sep 3, 2009
Registry last updated
Sep 9, 2014

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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