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Balloon pump assisted Coronary Intervention Study
ISRCTN ISRCTN40553718
DOI 10.1186/ISRCTN40553718
ClinicalTrials.gov identifier NCT00910481
EudraCT number
Public title Balloon pump assisted Coronary Intervention Study
Scientific title
Acronym BCIS-1
Serial number at source N/A
Study hypothesis 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.
Lay summary Not provided at time of registration
Ethics approval Approval received from the UK MREC for Scotland on the 28th April 2005 (ref. no.: 05/MRE00/43).
Study design Randomised controlled trial
Countries of recruitment United Kingdom
Disease/condition/study domain Multi-vessel coronary artery disease
Participants - 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
Participants - 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
Anticipated start date 01/12/2005
Anticipated end date 30/07/2006
Status of trial Completed
Patient information material
Target number of participants 300
Interventions 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.
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.
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
Sources of funding 1. Datascope (UK)
2. Cordis - a Johnson and Johnson Company (UK)
3. Eli Lilly and Company Limited (UK)
Trial website
Publications 1. 2009 protocol in http://www.ncbi.nlm.nih.gov/pubmed/19958856
2. 2010 results in http://www.ncbi.nlm.nih.gov/pubmed/20736470
3. 2012 results in http://www.ncbi.nlm.nih.gov/pubmed/23224207
Contact name Dr  Rodney  Stables
  Address Liverpool Cardiothoracic Centre
Thomas Drive
  City/town Liverpool
  Zip/Postcode L14 3PE
  Country United Kingdom
Sponsor British Cardiovascular Interventional Society (UK)
  Address Kings College Hospital
Denmark Hill
  City/town London
  Zip/Postcode SE5 9RS
  Country United Kingdom
  Sponsor website: http://www.bcis.org.uk/
Date applied 13/09/2006
Last edited 18/12/2012
Date ISRCTN assigned 13/02/2007
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