Balloon Pump Assisted Coronary Intervention Study

Study Results

Results available

Outcome measurements, participant flow, baseline characteristics, and adverse events have been published for this study.

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Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

NA

Total Enrollment

301 participants

Study Classification

INTERVENTIONAL

Study Start Date

2005-12-31

Study Completion Date

2012-12-31

Brief Summary

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This study will test the hypothesis that elective use of the Intra-Aortic Balloon Pump (IABP) in patients undergoing high-risk Percutaneous Coronary Intervention (PCI) will reduce the rate of in-hospital major adverse cardiac and cerebrovascular events compared to patients who are managed without planned insertion of IABP.

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Detailed Description

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Conditions

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Coronary Artery Disease Left Ventricular Dysfunction

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

TREATMENT

Blinding Strategy

NONE

Study Groups

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Elective IABP Insertion

Group Type EXPERIMENTAL

Intra-Aortic Balloon Pump

Intervention Type DEVICE

Elective IABP insertion before PCI

No Planned IABP Insertion

Group Type NO_INTERVENTION

No interventions assigned to this group

Interventions

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Intra-Aortic Balloon Pump

Elective IABP insertion before PCI

Intervention Type DEVICE

Eligibility Criteria

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Inclusion Criteria

* impaired left ventricular function (Ejection Fraction \< 30%)
* large area of myocardium at risk (BCIS-1 Myocardial Jeopardy Score ≥ 8/12)

Exclusion Criteria

* cardiogenic shock
* acute STEMI within previous 48 hours
* complications of recent AMI (including ventricular septal defect, severe mitral regurgitation, intractable ventricular arrhythmias)
* contraindications to IABP use (including significant iliac or femoral arterial disease and more than mild aortic regurgitation)

Minimum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No