Balloon pump assisted Coronary Intervention Study

ISRCTN	ISRCTN40553718
DOI	https://doi.org/10.1186/ISRCTN40553718
ClinicalTrials.gov (NCT)	NCT00910481
Protocol serial number	N/A
Sponsor	British Cardiovascular Intervention Society
Funders	Datascope (UK), Cordis - a Johnson and Johnson Company (UK), Eli Lilly and Company Limited (UK)

Submission date: 13/09/2006
Registration date: 13/02/2007
Last edited: 07/06/2023

Recruitment status: No longer recruiting
Overall study status: Completed
Condition category: Circulatory System

Prospectively registered

Protocol

Statistical analysis plan

Results

Individual participant data

Plain English summary of protocol

Not provided at time of registration

Contact information

Dr Rodney Stables
Scientific

Liverpool Cardiothoracic Centre
Thomas Drive
Liverpool
L14 3PE
United Kingdom

Study information

Primary study design	Interventional
Study design	Randomised controlled trial
Secondary study design	Randomised controlled trial
Scientific title	Balloon pump assisted Coronary Intervention Study
Study acronym	BCIS-1
Study objectives	Elective use of Intra-Aortic Balloon Pump (IABP) in high risk Percutaneous Coronary Intervention (PCI) patients will reduce the rate of in-hospital major adverse cardiovascular events compared to patients who are managed with no planned insertion of IABP.
Ethics approval(s)	Approval received from the UK MREC for Scotland on the 28th April 2005 (ref. no.: 05/MRE00/43).
Health condition(s) or problem(s) studied	Multi-vessel coronary artery disease
Intervention	In brief patients in the elective group will have the IABP inserted at the start of the procedure, before coronary intervention. Unless prolonged use is clinically indicated, the IABP will be removed four to 24 hours following PCI. An intravenous (iv) heparin infusion will be commenced on completion of the Abciximab infusion, with a target Activited Partial Thromboplastin Time (APTT) ratio between 1.5 and 2.5. When it is felt appropriate to remove the IABP, the heparin infusion will be discontinued and the balloon catheter removed when the Activated Clotting Time (ACT) falls below 160 seconds. Manual pressure haemostasis is recommended. In the No Planned group, bailout IABP insertion is at the discretion of the operator and would be considered acceptable if the following conditions occur during PCI: 1. Prolonged hypotension (relative to initial BP) 2. Refractory VT/VF 3. Pulmonary oedema Bailout IABP insertion will be recorded as a secondary outcome event and not as cross-over between treatment assignments, if inserted in the context of the above conditions.
Intervention type	Device
Phase	Not Specified
Drug / device / biological / vaccine name(s)	Balloon pump
Primary outcome measure(s)	Comparison of Major Adverse Cardiovascular Events (MACE) at hospital discharge or 28 days whichever is sooner. MACE includes death, myocardial infarction, cerebrovascular accident and repeat revascularisation.
Key secondary outcome measure(s)	1. Mortality at six months 2. Procedural success 3. Procedural complications 4. Bleeding complications 5. Access site complications 6. Transient ischaemic attacks 7. Length of hospital stay
Completion date	30/07/2006

Eligibility

Participant type(s)	Patient
Age group	Adult
Lower age limit	18 Years
Sex	All
Target sample size at registration	300
Key inclusion criteria	1. Patients at least 18 years of age 2. Proposed single or multi-vessel percutaneous intervention to native coronary arteries or coronary bypass grafts 3. Presence of BOTH the following high risk features: 3.1. Impaired Left Ventricular (LV) function: Ejection Fraction (EF) less than 30% (quantified by echocardiography or LV angiography) 3.2. Large area of myocardium at risk, either unprotected left main stem target lesion or Jeopardy Score more than or equal to eight, or target vessel provides collateral supply to an occluded second vessel which supplies more than 40% of myocardium 4. Written informed consent
Key exclusion criteria	1. Shock (systolic Blood Pressure [BP] less than 85 mmHg despite correction of hypovolaemia) 2. Acute myocardial infarction within previous 48 hours defined as: 2.1. chest pain or equivalent symptoms consistent with acute myocardial infarction, and 2.2. New ST segment elevation of at least 1 mm in two or more contiguous Electrocardiogram (ECG) leads, persisting for more than 15 minutes, or new left bundle branch block on ECG persisting for more than 15 minutes 3. Planned staged intervention procedure within 28 days of index PCI 4. Ventricular Septal Defect (VSD)/Mitral Regurgitation (MR) or intractable Ventricular Tachycardia and Ventricular Fibrillation (VT/VF) post Myocardial Infarction (MI) 5. Thoracic/abdominal aortic disease 6. Significant ilio-femoral artery disease (documented on Doppler studies or ilio-femoral angiography or absent femoral pulses bilaterally), the presence of clinical signs of acute leg ischaemia and previous bilateral femoral bypass graft surgery 7. More than mild aortic regurgitation on echocardiography 8. Bleeding diathesis or Warfarin therapy with International Normalised Ratio (INR) more than 2.5 9. Active internal bleeding (except menstruation) 10. Allergy to aspirin, clopidogrel, heparin or Glycoprotein (GP) IIb/IIIa inhibitors 11. Thrombocytopenia (platelet count less than 100,000 cells/mm^3) 12. Women who are pregnant 13. Patients who have previously been enrolled in this study
Date of first enrolment	01/12/2005
Date of final enrolment	30/07/2006

Locations

Countries of recruitment

United Kingdom
England

Study participating centre

Liverpool Cardiothoracic Centre

Liverpool
L14 3PE
United Kingdom

Results and Publications

Individual participant data (IPD) Intention to share	No
IPD sharing plan summary	Not provided at time of registration
IPD sharing plan	Not provided at time of registration

Study outputs

Output type	Details	Date created	Peer reviewed?	Patient-facing?
Results article	results	25/08/2010	Yes	No
Results article	results	15/01/2013	Yes	No
Protocol article	protocol	01/12/2009	Yes	No

Editorial Notes

07/06/2023: Internal review.