Balloon pump assisted Coronary Intervention Study
| ISRCTN | ISRCTN40553718 |
|---|---|
| DOI | https://doi.org/10.1186/ISRCTN40553718 |
| ClinicalTrials.gov number | NCT00910481 |
| Secondary identifying numbers | N/A |
- 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
Not provided at time of registration
Contact information
Dr Rodney Stables
Scientific
Scientific
Liverpool Cardiothoracic Centre
Thomas Drive
Liverpool
L14 3PE
United Kingdom
Study information
| Study design | Randomised controlled trial |
|---|---|
| Primary study design | Interventional |
| Secondary study design | Randomised controlled trial |
| Study setting(s) | Hospital |
| Study type | Treatment |
| Scientific title | Balloon pump assisted Coronary Intervention Study |
| Study acronym | BCIS-1 |
| 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. |
| Ethics approval(s) | Approval received from the UK MREC for Scotland on the 28th April 2005 (ref. no.: 05/MRE00/43). |
| Condition | 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 |
| Pharmaceutical study type(s) | Not Applicable |
| Phase | Not Specified |
| Drug / device / biological / vaccine name(s) | Balloon pump |
| Primary outcome measure | 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 measures | 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 |
| Overall study start date | 01/12/2005 |
| Overall study end date | 30/07/2006 |
Eligibility
| Participant type(s) | Patient |
|---|---|
| Age group | Adult |
| Lower age limit | 18 Years |
| Sex | Both |
| Target number of participants | 300 |
| Participant 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 |
| Participant 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 |
| Recruitment start date | 01/12/2005 |
| Recruitment end date | 30/07/2006 |
Locations
Countries of recruitment
- England
- United Kingdom
Study participating centre
Liverpool Cardiothoracic Centre
Liverpool
L14 3PE
United Kingdom
L14 3PE
United Kingdom
Sponsor information
British Cardiovascular Intervention Society
Research organisation
Research organisation
Kings College Hospital
Denmark Hill
London
SE5 9RS
United Kingdom
| Website | http://www.bcis.org.uk/ |
|---|---|
"ROR" |
https://ror.org/03dnhfz27 |
Funders
Funder type
Industry
Datascope (UK)
No information available
Cordis - a Johnson and Johnson Company (UK)
No information available
Eli Lilly and Company Limited (UK)
No information available
Results and Publications
| Intention to publish date | |
|---|---|
| Individual participant data (IPD) Intention to share | No |
| IPD sharing plan summary | Not provided at time of registration |
| Publication and dissemination plan | Not provided at time of registration |
| IPD sharing plan | Not provided at time of registration |
Study outputs
| Output type | Details | Date created | Date added | Peer reviewed? | Patient-facing? |
|---|---|---|---|---|---|
| Protocol article | protocol | 01/12/2009 | Yes | No | |
| Results article | results | 25/08/2010 | Yes | No | |
| Results article | results | 15/01/2013 | Yes | No |
Editorial Notes
07/06/2023: Internal review.
