Clinical trial NCT00910481: Balloon Pump Assisted Coronary Intervention Study
Official title: Balloon Pump Assisted Coronary Intervention Study
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Coronary Artery Disease
Left Ventricular Dysfunction
Keywords: Coronary Artery Disease
Percutaneous Transluminal Coronary Angioplasty
Intraaortic Balloon Pumping
Left Ventricular Dysfunction
High Risk
Lead sponsor: British Cardiovascular Intervention Society
Sponsor class: OTHER
First posted: 2009-05-29
Enrollment: 301
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

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.


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)

Primary outcomes:
measure: Major Adverse Cardiac and Cerebrovascular Events
timeFrame: Hospital discharge or 28 days following PCI, whichever occurs sooner
Secondary outcomes:
measure: All-cause Mortality
timeFrame: 6-months following randomization
measure: Major Procedural Complications
timeFrame: Duration of PCI procedure
measure: Bleeding Complications (Major and Minor)
timeFrame: Hospital Discharge or 28 days following PCI (whichever occurs sooner)
measure: Access Site Complications
timeFrame: Hospital Discharge or 28 days following PCI (whichever occurs sooner)
measure: Transient Ischemic Attack
timeFrame: Hospital Discharge or 28 days following PCI (whichever occurs sooner)
measure: Length of Hospital Stay
timeFrame: Hospital Discharge
measure: Procedural Success
timeFrame: Duration of PCI procedure
Other outcomes:
Locations:
city: London
country: United Kingdom
facility: British Cardiovascular Intervention Society
Study officials:
affiliation: Guy's and St Thomas' Hospital NHSFT, London, UK
name: Divaka Perera, MRCP, MD
role: PRINCIPAL_INVESTIGATOR
affiliation: Guy's and St Thomas' Hospital NHSFT, London, UK
name: Simon Redwood, FRCP, MD
role: PRINCIPAL_INVESTIGATOR
affiliation: Liverpool Cardiothoracic Centre, Liverpool, UK
name: Rodney Stables, FRCP, DM
role: PRINCIPAL_INVESTIGATOR
affiliation: Guy's and St Thomas' Hospital NHSFT, London, UK
name: Martyn Thomas, FRCP, MD
role: PRINCIPAL_INVESTIGATOR
References:
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.
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.
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.