Balloon Pump Assisted Coronary Intervention Study (BCIS-1)

February 6, 2021 updated by: Dr Divaka Perera, British Cardiovascular Intervention Society
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.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Study Type

Interventional

Enrollment (Actual)

301

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • United Kingdom
      • London, United Kingdom
        • British Cardiovascular Intervention Society

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years and older (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

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)

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: Elective IABP Insertion
Device: Intra-Aortic Balloon Pump
Elective IABP insertion before PCI
No Intervention: No Planned IABP Insertion

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Major Adverse Cardiac and Cerebrovascular Events
Time Frame: Hospital discharge or 28 days following PCI, whichever occurs sooner
(composite endpoint of death, acute myocardial infarction, further revascularization or cerebrovascular event)
Hospital discharge or 28 days following PCI, whichever occurs sooner

Secondary Outcome Measures

Outcome Measure
Time Frame
All-cause Mortality
Time Frame: 6-months following randomization
6-months following randomization
Major Procedural Complications
Time Frame: Duration of PCI procedure
Duration of PCI procedure
Bleeding Complications (Major and Minor)
Time Frame: Hospital Discharge or 28 days following PCI (whichever occurs sooner)
Hospital Discharge or 28 days following PCI (whichever occurs sooner)
Access Site Complications
Time Frame: Hospital Discharge or 28 days following PCI (whichever occurs sooner)
Hospital Discharge or 28 days following PCI (whichever occurs sooner)
Transient Ischemic Attack
Time Frame: Hospital Discharge or 28 days following PCI (whichever occurs sooner)
Hospital Discharge or 28 days following PCI (whichever occurs sooner)
Length of Hospital Stay
Time Frame: Hospital Discharge
Hospital Discharge
Procedural Success
Time Frame: Duration of PCI procedure
Duration of PCI procedure

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

British Cardiovascular Intervention Society

Investigators

  • Principal Investigator: Divaka Perera, MRCP, MD, Guy's and St Thomas' Hospital NHSFT, London, UK
  • Principal Investigator: Simon Redwood, FRCP, MD, Guy's and St Thomas' Hospital NHSFT, London, UK
  • Principal Investigator: Rodney Stables, FRCP, DM, Liverpool Cardiothoracic Centre, Liverpool, UK
  • Principal Investigator: Martyn Thomas, FRCP, MD, Guy's and St Thomas' Hospital NHSFT, London, UK

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

December 1, 2005

Primary Completion (Actual)

January 1, 2011

Study Completion (Actual)

December 1, 2012

Study Registration Dates

First Submitted

May 28, 2009

First Submitted That Met QC Criteria

May 28, 2009

First Posted (Estimate)

May 29, 2009

Study Record Updates

Last Update Posted (Actual)

February 25, 2021

Last Update Submitted That Met QC Criteria

February 6, 2021

Last Verified

February 1, 2021

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • ISRCTN40553718

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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