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Balloon Pump Assisted Coronary Intervention Study (BCIS-1)

Primary Purpose

Coronary Artery Disease, Left Ventricular Dysfunction

Status
Completed
Phase
Not Applicable
Locations
United Kingdom
Study Type
Interventional
Intervention
Intra-Aortic Balloon Pump
Sponsored by
British Cardiovascular Intervention Society
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Coronary Artery Disease focused on measuring Coronary Artery Disease, Percutaneous Transluminal Coronary Angioplasty, Intraaortic Balloon Pumping, Left Ventricular Dysfunction, High Risk

Eligibility Criteria

18 Years - undefined (Adult, Older Adult)All SexesDoes not accept 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)

Sites / Locations

  • British Cardiovascular Intervention Society

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

No Intervention

Arm Label

Elective IABP Insertion

No Planned IABP Insertion

Arm Description

Outcomes

Primary Outcome Measures

Major Adverse Cardiac and Cerebrovascular Events
(composite endpoint of death, acute myocardial infarction, further revascularization or cerebrovascular event)

Secondary Outcome Measures

All-cause Mortality
Major Procedural Complications
Bleeding Complications (Major and Minor)
Access Site Complications
Transient Ischemic Attack
Length of Hospital Stay
Procedural Success

Full Information

First Posted
May 28, 2009
Last Updated
February 6, 2021
Sponsor
British Cardiovascular Intervention Society
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1. Study Identification

Unique Protocol Identification Number
NCT00910481
Brief Title
Balloon Pump Assisted Coronary Intervention Study
Acronym
BCIS-1
Official Title
Balloon Pump Assisted Coronary Intervention Study
Study Type
Interventional

2. Study Status

Record Verification Date
February 2021
Overall Recruitment Status
Completed
Study Start Date
December 2005 (undefined)
Primary Completion Date
January 2011 (Actual)
Study Completion Date
December 2012 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
British Cardiovascular Intervention Society

4. Oversight

Data Monitoring Committee
Yes

5. Study Description

Brief Summary
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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Coronary Artery Disease, Left Ventricular Dysfunction
Keywords
Coronary Artery Disease, Percutaneous Transluminal Coronary Angioplasty, Intraaortic Balloon Pumping, Left Ventricular Dysfunction, High Risk

7. Study Design

Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
None (Open Label)
Allocation
Randomized
Enrollment
301 (Actual)

8. Arms, Groups, and Interventions

Arm Title
Elective IABP Insertion
Arm Type
Experimental
Arm Title
No Planned IABP Insertion
Arm Type
No Intervention
Intervention Type
Device
Intervention Name(s)
Intra-Aortic Balloon Pump
Intervention Description
Elective IABP insertion before PCI
Primary Outcome Measure Information:
Title
Major Adverse Cardiac and Cerebrovascular Events
Description
(composite endpoint of death, acute myocardial infarction, further revascularization or cerebrovascular event)
Time Frame
Hospital discharge or 28 days following PCI, whichever occurs sooner
Secondary Outcome Measure Information:
Title
All-cause Mortality
Time Frame
6-months following randomization
Title
Major Procedural Complications
Time Frame
Duration of PCI procedure
Title
Bleeding Complications (Major and Minor)
Time Frame
Hospital Discharge or 28 days following PCI (whichever occurs sooner)
Title
Access Site Complications
Time Frame
Hospital Discharge or 28 days following PCI (whichever occurs sooner)
Title
Transient Ischemic Attack
Time Frame
Hospital Discharge or 28 days following PCI (whichever occurs sooner)
Title
Length of Hospital Stay
Time Frame
Hospital Discharge
Title
Procedural Success
Time Frame
Duration of PCI procedure

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
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)
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Divaka Perera, MRCP, MD
Organizational Affiliation
Guy's and St Thomas' Hospital NHSFT, London, UK
Official's Role
Principal Investigator
First Name & Middle Initial & Last Name & Degree
Simon Redwood, FRCP, MD
Organizational Affiliation
Guy's and St Thomas' Hospital NHSFT, London, UK
Official's Role
Principal Investigator
First Name & Middle Initial & Last Name & Degree
Rodney Stables, FRCP, DM
Organizational Affiliation
Liverpool Cardiothoracic Centre, Liverpool, UK
Official's Role
Principal Investigator
First Name & Middle Initial & Last Name & Degree
Martyn Thomas, FRCP, MD
Organizational Affiliation
Guy's and St Thomas' Hospital NHSFT, London, UK
Official's Role
Principal Investigator
Facility Information:
Facility Name
British Cardiovascular Intervention Society
City
London
Country
United Kingdom

12. IPD Sharing Statement

Citations:
PubMed Identifier
23224207
Citation
Perera D, Stables R, Clayton T, De Silva K, Lumley M, Clack L, Thomas M, Redwood S; BCIS-1 Investigators. Long-term mortality data from the balloon pump-assisted coronary intervention study (BCIS-1): a randomized, controlled trial of elective balloon counterpulsation during high-risk percutaneous coronary intervention. Circulation. 2013 Jan 15;127(2):207-12. doi: 10.1161/CIRCULATIONAHA.112.132209. Epub 2012 Dec 6.
Results Reference
result
PubMed Identifier
20736470
Citation
Perera D, Stables R, Thomas M, Booth J, Pitt M, Blackman D, de Belder A, Redwood S; BCIS-1 Investigators. Elective intra-aortic balloon counterpulsation during high-risk percutaneous coronary intervention: a randomized controlled trial. JAMA. 2010 Aug 25;304(8):867-74. doi: 10.1001/jama.2010.1190.
Results Reference
result
PubMed Identifier
19958856
Citation
Perera D, Stables R, Booth J, Thomas M, Redwood S; BCIS-1 Investigators. The balloon pump-assisted coronary intervention study (BCIS-1): rationale and design. Am Heart J. 2009 Dec;158(6):910-916.e2. doi: 10.1016/j.ahj.2009.09.015.
Results Reference
derived

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Balloon Pump Assisted Coronary Intervention Study

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