NCT00970827

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.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
360

participants targeted

Target at P75+ for phase_2 coronary-artery-disease

Timeline
Completed

Started May 2009

Longer than P75 for phase_2 coronary-artery-disease

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

May 1, 2009

Completed
2 months until next milestone

First Submitted

Initial submission to the registry

July 9, 2009

Completed
2 months until next milestone

First Posted

Study publicly available on registry

September 3, 2009

Completed
4.7 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

June 1, 2014

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

June 1, 2014

Completed
Last Updated

September 9, 2014

Status Verified

September 1, 2014

Enrollment Period

5.1 years

First QC Date

July 9, 2009

Last Update Submit

September 8, 2014

Conditions

Coronary Artery Disease

Keywords

Coronary artery diseasePCIPostconditioningElective or urgent PCI

Outcome Measures

Primary Outcomes (1)

  • Myocardial injury after PCI.

    24 hours

Secondary Outcomes (3)

  • To study the effects of different degrees of remote ischemic postconditioning on myocardial necrosis and inflammation following PCI.

    24 hours

  • Platelet function

    24 hours

  • Cardiac events

    One year

Study Arms (3)

1

ACTIVE COMPARATOR

Leg postconditioning

Procedure: remote ischemic postconditioning

2

ACTIVE COMPARATOR

Arm postconditioning

Procedure: remote ischemic postconditioning

3

PLACEBO COMPARATOR

Control group

Procedure: remote ischemic postconditioning

Interventions

remote ischemic postconditioningPROCEDURE

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).

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Eligibility Criteria

Age18 Years+
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • Patients scheduled for PCI

You may not qualify if:

  • 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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

London Health Sceinces Centre

London, Ontario, N6A5A5, Canada

Location

Related Publications (2)

  • Lavi S, Abu-Romeh N, Wall S, Alemayehu M, Lavi R. Long-term outcome following remote ischemic postconditioning during percutaneous coronary interventions-the RIP-PCI trial long-term follow-up. Clin Cardiol. 2017 May;40(5):268-274. doi: 10.1002/clc.22668. Epub 2017 Jan 11.

    PMID: 28075499DERIVED

  • 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.

    PMID: 24692535DERIVED

MeSH Terms

Conditions

Coronary Artery Disease

Condition Hierarchy (Ancestors)

Coronary DiseaseMyocardial IschemiaHeart DiseasesCardiovascular DiseasesArteriosclerosisArterial Occlusive DiseasesVascular Diseases

Study Officials

  • Shahar Lavi, MD

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

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
phase 2
Allocation
RANDOMIZED
Masking
DOUBLE
Who Masked
CARE PROVIDER, OUTCOMES ASSESSOR
Purpose
PREVENTION
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Principal Investigator

Study Record Dates

First Submitted

July 9, 2009

First Posted

September 3, 2009

Study Start

May 1, 2009

Primary Completion

June 1, 2014

Study Completion

June 1, 2014

Last Updated

September 9, 2014

Record last verified: 2014-09

Locations

CA(1)