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

L

Lawson Health Research Institute

Status and phase

Completed
Phase 2

Conditions

Coronary Artery Disease

Treatments

Procedure: remote ischemic postconditioning

Study type

Interventional

Funder types

Other

Identifiers

NCT00970827
15664 (Other Identifier)
R-09-015

Details and patient eligibility

About

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.

Enrollment

360 patients

Sex

All

Ages

18+ years old

Volunteers

No 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

Trial design

Primary purpose

Prevention

Allocation

Randomized

Interventional model

Parallel Assignment

Masking

Double Blind

360 participants in 3 patient groups, including a placebo group

1
Active Comparator group
Description:
Leg postconditioning
Treatment:
Procedure: remote ischemic postconditioning
2
Active Comparator group
Description:
Arm postconditioning
Treatment:
Procedure: remote ischemic postconditioning
3
Placebo Comparator group
Description:
Control group
Treatment:
Procedure: remote ischemic postconditioning

Trial contacts and locations

1

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Data sourced from clinicaltrials.gov

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