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| ID | Type | Description | Link |
|---|---|---|---|
| ISRCTN40553718 |
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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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Elective IABP Insertion | Experimental |
| |
| No Planned IABP Insertion | No Intervention |
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Intra-Aortic Balloon Pump | Device | Elective IABP insertion before PCI |
|
| Measure | Description | Time Frame |
|---|---|---|
| Major Adverse Cardiac and Cerebrovascular Events | (composite endpoint of death, acute myocardial infarction, further revascularization or cerebrovascular event) | Hospital discharge or 28 days following PCI, whichever occurs sooner |
| Measure | Description | Time Frame |
|---|---|---|
| All-cause Mortality | 6-months following randomization | |
| Major Procedural Complications | Duration of PCI procedure | |
| Bleeding Complications (Major and Minor) |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| 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 | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| British Cardiovascular Intervention Society | London | United Kingdom |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 23224207 | Result | 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. | |
| 20736470 |
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| ID | Title | Description |
|---|---|---|
| FG000 | Elective IABP Insertion | Intra-Aortic Balloon Pump: Elective IABP insertion before PCI |
| FG001 | No Planned IABP Insertion |
| Title | Milestones | Reasons Not Completed | ||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Overall Study |
|
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| ID | Title | Description |
|---|---|---|
| BG000 | Elective IABP Insertion | Left ventricular ejection fraction was 23.6% (SD, 5.2%) in the elective IABP group |
| BG001 | No Planned IABP Insertion | Left ventricular ejection fraction was 23.6% (SD, 5.5%) in the no planned IABP group |
| Units | Counts |
|---|---|
| Participants |
|
| Title | Description | Population Description | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Denominator Units Selected | Denominators | Classes |
|---|---|---|---|---|---|---|---|---|---|
| Age, Categorical | Count of Participants |
| Type | Title | Description | Population Description | Reporting Status | Anticipated Posting Date | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Time Frame | Units Analyzed | Denominator Units Selected | Arm/Group Information | Denominators | Classes | Analyses | ||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Primary | Major Adverse Cardiac and Cerebrovascular Events | (composite endpoint of death, acute myocardial infarction, further revascularization or cerebrovascular event) | All | Posted | Count of Participants | Participants | Hospital discharge or 28 days following PCI, whichever occurs sooner |
|
|
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| ID | Title | Description | Deaths (Affected) | Deaths (At Risk) | Serious Events (Affected) | Serious Events (At Risk) | Other Events (Affected) | Other Events (At Risk) |
|---|---|---|---|---|---|---|---|---|
| EG000 | Elective IABP Insertion | Intra-Aortic Balloon Pump: Elective IABP insertion before PCI |
| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| CVA | Nervous system disorders | Systematic Assessment |
| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Procedural Complications | Cardiac disorders | Systematic Assessment | Overall, rescue IABP insertion was required in 18 patients assigned to have no planned IABP insertion, including 13 for procedural hypotension, 1 for pulmonary edema, and 1 for sudden vessel closure. |
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| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| Professor Divaka Perera | King's College London | 02071887188 | divaka.perera@kcl.ac.uk |
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| ID | Term |
|---|---|
| D003324 | Coronary Artery Disease |
| D018487 | Ventricular Dysfunction, Left |
| ID | Term |
|---|---|
| D003327 | Coronary Disease |
| D017202 | Myocardial Ischemia |
| D006331 | Heart Diseases |
| D002318 | Cardiovascular Diseases |
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| ID | Term |
|---|---|
| D007423 | Intra-Aortic Balloon Pumping |
| ID | Term |
|---|---|
| D015908 | Counterpulsation |
| D001243 | Assisted Circulation |
| D013514 | Surgical Procedures, Operative |
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| Hospital Discharge or 28 days following PCI (whichever occurs sooner) |
| Access Site Complications | Hospital Discharge or 28 days following PCI (whichever occurs sooner) |
| Transient Ischemic Attack | Hospital Discharge or 28 days following PCI (whichever occurs sooner) |
| Length of Hospital Stay | Hospital Discharge |
| Procedural Success | Duration of PCI procedure |
| Result |
| 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. |
| 19958856 | Derived | 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. |
| BG002 | Total | Total of all reporting groups |
| Participants |
|
| Sex: Female, Male | Count of Participants | Participants |
|
| Counts |
|---|
| Participants |
|
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| Secondary | All-cause Mortality | Not Posted | 6-months following randomization | Participants |
| Secondary | Major Procedural Complications | Not Posted | Duration of PCI procedure | Participants |
| Secondary | Bleeding Complications (Major and Minor) | Not Posted | Hospital Discharge or 28 days following PCI (whichever occurs sooner) | Participants |
| Secondary | Access Site Complications | Not Posted | Hospital Discharge or 28 days following PCI (whichever occurs sooner) | Participants |
| Secondary | Transient Ischemic Attack | Not Posted | Hospital Discharge or 28 days following PCI (whichever occurs sooner) | Participants |
| Secondary | Length of Hospital Stay | Not Posted | Hospital Discharge | Participants |
| Secondary | Procedural Success | Not Posted | Duration of PCI procedure | Participants |
| 3 |
| 151 |
| 2 |
| 151 |
| 2 |
| 151 |
| EG001 | No Planned IABP Insertion | 1 | 150 | 0 | 150 | 16 | 150 |
|
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| D001161 |
| Arteriosclerosis |
| D001157 | Arterial Occlusive Diseases |
| D014652 | Vascular Diseases |
| D018754 | Ventricular Dysfunction |