Balloon Pump Assisted Coronary Intervention Study (BCIS-1)

British Cardiovascular Intervention Society

Status: Completed

Conditions: Coronary Artery Disease; Left Ventricular Dysfunction

Treatments: Device: Intra-Aortic Balloon Pump

Study type: Interventional

Funder types: Other

Identifiers

NCT00910481

ISRCTN40553718

Details and patient eligibility

About

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.

Enrollment: 301 patients

Sex: All

Ages: 18+ years old

Volunteers: No Healthy Volunteers

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)

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: None (Open label)

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301 participants in 2 patient groups

Elective IABP Insertion

Experimental group

Treatment:

Device: Intra-Aortic Balloon Pump

No Planned IABP Insertion

No Intervention group