Balloon Pump Assisted Coronary Intervention Study (BCIS-1)

The recruitment status of this study is unknown because the information has not been verified recently.
Verified May 2009 by British Cardiovascular Intervention Society.
Recruitment status was  Active, not recruiting
Sponsor:
Information provided by:
British Cardiovascular Intervention Society
ClinicalTrials.gov Identifier:
NCT00910481
First received: May 28, 2009
Last updated: NA
Last verified: May 2009
History: No changes posted
  Purpose

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.


Condition Intervention
Coronary Artery Disease
Left Ventricular Dysfunction
Device: Intra-Aortic Balloon Pump

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Parallel Assignment
Masking: Open Label
Primary Purpose: Treatment
Official Title: Balloon Pump Assisted Coronary Intervention Study

Further study details as provided by British Cardiovascular Intervention Society:

Primary Outcome Measures:
  • Major Adverse Cardiac and Cerebrovascular Events (composite endpoint of death, acute myocardial infarction, further revascularization or cerebrovascular event) [ Time Frame: Hospital discharge or 28 days following PCI, whichever occurs sooner ] [ Designated as safety issue: No ]

Secondary Outcome Measures:
  • All-cause mortality [ Time Frame: 6-months following randomization ] [ Designated as safety issue: No ]
  • Major Procedural Complications [ Time Frame: Duration of PCI procedure ] [ Designated as safety issue: No ]
  • Bleeding Complications (Major and Minor) [ Time Frame: Hospital Discharge or 28 days following PCI (whichever occurs sooner) ] [ Designated as safety issue: Yes ]
  • Access Site Complications [ Time Frame: Hospital Discharge or 28 days following PCI (whichever occurs sooner) ] [ Designated as safety issue: Yes ]
  • Transient Ischemic Attack [ Time Frame: Hospital Discharge or 28 days following PCI (whichever occurs sooner) ] [ Designated as safety issue: No ]
  • Length of Hospital Stay [ Time Frame: Hospital Discharge ] [ Designated as safety issue: No ]
  • Procedural Success [ Time Frame: Duration of PCI procedure ] [ Designated as safety issue: No ]

Enrollment: 301
Study Start Date: December 2005
Estimated Study Completion Date: September 2009
Estimated Primary Completion Date: June 2009 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: Elective IABP Insertion Device: Intra-Aortic Balloon Pump
Elective IABP insertion before PCI
No Intervention: No Planned IABP Insertion

  Eligibility

Ages Eligible for Study:   18 Years and older
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
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)
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT00910481

Locations
United Kingdom
British Cardiovascular Intervention Society
London, United Kingdom
Sponsors and Collaborators
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
  More Information

No publications provided by British Cardiovascular Intervention Society

Additional publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):
Responsible Party: Dr Simon Redwood (PI), British Cardiovascular Intervention Society
ClinicalTrials.gov Identifier: NCT00910481     History of Changes
Other Study ID Numbers: ISRCTN40553718, ISRCTN40553718
Study First Received: May 28, 2009
Last Updated: May 28, 2009
Health Authority: United Kingdom: Research Ethics Committee

Keywords provided by British Cardiovascular Intervention Society:
Coronary Artery Disease
Percutaneous Transluminal Coronary Angioplasty
Intraaortic Balloon Pumping
Left Ventricular Dysfunction
High Risk

Additional relevant MeSH terms:
Coronary Artery Disease
Coronary Disease
Myocardial Ischemia
Ventricular Dysfunction
Ventricular Dysfunction, Left
Arterial Occlusive Diseases
Arteriosclerosis
Cardiovascular Diseases
Heart Diseases
Vascular Diseases

ClinicalTrials.gov processed this record on October 20, 2014