Coronary Artery DiseaseBCIS-1NCT00910481

Balloon Pump Assisted Coronary Intervention Study

A study testing Intra-Aortic Balloon Pump in people with Coronary Artery Disease and Left Ventricular Dysfunction, run by British Cardiovascular Intervention Society at 1 site in United Kingdom.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record

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Trial 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… Read more about this study

Who is it for?: Ages 18 years and older
Conditions the study is for: Coronary Artery Disease, Left Ventricular Dysfunction
What is being tested?: Intra-Aortic Balloon Pump
Type of treatment: Medical device
Could I receive a placebo?: No, everyone receives an active treatment
How many people: 301 participants
Where: 1 siteUnited Kingdom
Study dates: Dec 2005to Dec 2012
Phase: Interventional
Are there results?: Yes, posted in the registrySummary in the doctors' view

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

Ages 18 years and older
All sexes
No healthy volunteers
Adult, Older adult

Who may be able to join

impaired left ventricular function (Ejection Fraction < 30%)
large area of myocardium at risk (BCIS-1 Myocardial Jeopardy Score ≥ 8/12)

Who cannot join

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)

Trial locations and contacts

1 site in 1 country.

United Kingdom1 site

British Cardiovascular Intervention Society
London

Other trials in United Kingdom

About this study

Conditions: Coronary Artery Disease, Left Ventricular Dysfunction
Being tested: Intra-Aortic Balloon Pump
Keywords: Coronary Artery Disease, Percutaneous Transluminal Coronary Angioplasty, Intraaortic Balloon Pumping, Left Ventricular Dysfunction, High Risk
Medical subject headings: Coronary Artery Disease, Ventricular Dysfunction, Left

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

Intra-Aortic Balloon PumpDevice
Elective IABP insertion before PCI

Study groups in NCT00910481
Study group	Role	What they receive
Elective IABP Insertion	Experimental	Not described Receives: Device: Intra-Aortic Balloon Pump
No Planned IABP Insertion	No intervention	Not described

What is being measured

The primary outcome is the main question the study is designed to answer.

Major Adverse Cardiac and Cerebrovascular Events
(composite endpoint of death, acute myocardial infarction, further revascularization or cerebrovascular event)
Measured: Hospital discharge or 28 days following PCI, whichever occurs sooner

Secondary outcomes (7)

All-cause Mortality
Measured: 6-months following randomization
Major Procedural Complications
Measured: Duration of PCI procedure
Bleeding Complications (Major and Minor)
Measured: Hospital Discharge or 28 days following PCI (whichever occurs sooner)
Access Site Complications
Measured: Hospital Discharge or 28 days following PCI (whichever occurs sooner)
Transient Ischemic Attack
Measured: Hospital Discharge or 28 days following PCI (whichever occurs sooner)
Length of Hospital Stay
Measured: Hospital Discharge
Procedural Success
Measured: Duration of PCI procedure

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

Dec 2005Dec 2012

First posted29 May 2009 (estimated)
Study startDec 2005
Primary completionJan 2011
Study completionDec 2012

Resources

Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
Posted resultsParticipant flow, outcome measures and adverse events reported by the sponsor.
Publications (3)Papers the sponsor has linked to this study.
Other trials for Coronary Artery DiseaseStudies of the same condition, open and under way.
What the trial phases meanHow a treatment moves from first tests in people to approval.

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design

Study type: Interventional
Phase: Phase N/A
Primary purpose: Treatment
Allocation: Randomised
Intervention model: Parallel groups
Masking: None (open label)
Enrolment: 301 participants (actual)

IDs, dates and publications

ClinicalTrials.gov ID: NCT00910481
Sponsor's protocol ID: ISRCTN40553718
Other IDs: ISRCTN40553718
Acronym: BCIS-1
Status last verified: Aug 2024
First submitted: 28 May 2009
Last updated: 7 Aug 2024
Results posted: Yes, on ClinicalTrials.gov
Data monitoring committee: Yes

Publications

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.
PubMed 23224207
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.
PubMed 20736470
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.
PubMed 19958856

Want to know more?

The sponsor has not listed a contact. The official record may have more details.

Talk to your doctor first and take this page with you. Only the study team can confirm whether you can join.

Questions to ask the study team

What is the study trying to find out?
What would I need to do, and how often would I visit?
Could I receive a placebo instead of the treatment?
What are the possible risks and benefits for me?
Will it cost me anything? Are travel or time paid for?
Can I keep seeing my own doctor during the study?
What happens when the study ends?

See locations

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Study at a glance

From the registry record, last updated by the sponsor on 7 Aug 2024. Recruitment status is as the sponsor reported it: confirm with the study team.

Official title: Balloon Pump Assisted Coronary Intervention Study
ClinicalTrials.gov ID: NCT00910481
Acronym / sponsor ID: BCIS-1 / ISRCTN40553718
Conditions: Coronary Artery Disease, Left Ventricular Dysfunction
Keywords: Coronary Artery Disease, Percutaneous Transluminal Coronary Angioplasty, Intraaortic Balloon Pumping, Left Ventricular Dysfunction, High Risk
Study type: Interventional
Recruitment status: Completed
Enrolment: 301 participants (actual)
Lead sponsor: British Cardiovascular Intervention SocietyUniversity, hospital or other
Study start: Dec 2005
Primary completion: Jan 2011 (actual)
Study completion: Dec 2012 (actual)
First posted: 29 May 2009 (estimated)
Results: Posted 25 Feb 2021

Clinical summary

The research question as the sponsor registered it. This describes what the study plans to test, not what it found.

Study design

Primary purpose: Treatment
Allocation: Randomised
Intervention model: Parallel groups
Masking: None (open label)
Number of arms: 2

Arm	Type	Receives
Elective IABP Insertion	Experimental	Device: Intra-Aortic Balloon Pump
No Planned IABP Insertion	No intervention	–

Who may qualify

Ages: 18 years and older
Sex: All
Healthy volunteers: Not accepted
Age groups: Adult, Older adult

Key inclusion criteria (2 listed)

impaired left ventricular function (Ejection Fraction < 30%)
large area of myocardium at risk (BCIS-1 Myocardial Jeopardy Score ≥ 8/12)

Key exclusion criteria (4 listed)

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)

Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.

Interventions

Intervention	Type	Arms
Intra-Aortic Balloon PumpElective IABP insertion before PCI	Device	Elective IABP Insertion

Primary outcome

Major Adverse Cardiac and Cerebrovascular Events
Time frame: Hospital discharge or 28 days following PCI, whichever occurs sooner
(composite endpoint of death, acute myocardial infarction, further revascularization or cerebrovascular event)

7 secondary outcomes

All-cause Mortality
Time frame: 6-months following randomization
Major Procedural Complications
Time frame: Duration of PCI procedure
Bleeding Complications (Major and Minor)
Time frame: Hospital Discharge or 28 days following PCI (whichever occurs sooner)
Access Site Complications
Time frame: Hospital Discharge or 28 days following PCI (whichever occurs sooner)
Transient Ischemic Attack
Time frame: Hospital Discharge or 28 days following PCI (whichever occurs sooner)
Length of Hospital Stay
Time frame: Hospital Discharge
Procedural Success
Time frame: Duration of PCI procedure

Results and safety

Results posted to the registry on 25 Feb 2021, as reported by the sponsor. Figures are copied from the record, not re-analysed. Full results on ClinicalTrials.gov.

Participant flow

Group	Started	Completed
Elective IABP Insertion	151	151
No Planned IABP Insertion	150	150

Primary outcome: Major Adverse Cardiac and Cerebrovascular Events

Time frame: Hospital discharge or 28 days following PCI, whichever occurs sooner. Count of participants. Unit: Participants

Measure	Elective IABP Insertion n = 151	No Planned IABP Insertion n = 150
Value	23	24

Population analysed: All

7 secondary outcomes are reported in the full results.

Adverse events

Other adverse events reported at 5% frequency or more

Group	Serious adverse events	Other adverse events	Deaths
Elective IABP Insertion	2 of 151 (1.3%)	2 of 151 (1.3%)	3 of 151
No Planned IABP Insertion	0 of 150 (0%)	16 of 150 (10.7%)	1 of 150

Loading the posted results from ClinicalTrials.gov…

Research links

Official record on ClinicalTrials.govLast updated by the sponsor 7 Aug 2024.
Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
Results publication: PubMed 23224207Perera 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.
Results publication: PubMed 20736470Perera 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.
Derived from this study: PubMed 19958856Perera 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.

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Heterozygous Familial Hypercholesterolemia (HeFH)
Active, not recruitingPhase 3
Coronary Computed Tomography Study to Assess the Effect of Inclisiran in Addition to Maximally Tolerated Statin Therapy on Atherosclerotic Plaque Progression in Participants With a Diagnosis of Non-obstructive Coronary Artery Disease Without Previous Cardiovascular Events
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Referral and contact

AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.

Divaka Perera, MRCP, MD principal investigator

Guy's and St Thomas' Hospital NHSFT, London, UK

Simon Redwood, FRCP, MD principal investigator

Guy's and St Thomas' Hospital NHSFT, London, UK

Rodney Stables, FRCP, DM principal investigator

Liverpool Cardiothoracic Centre, Liverpool, UK

1 site in 1 country: see every site and its status.

Questions about this trial

What is this clinical trial studying?

A study testing Intra-Aortic Balloon Pump in people with Coronary Artery Disease and Left Ventricular Dysfunction, run by British Cardiovascular Intervention Society at 1 site in United Kingdom.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 2 inclusion and 4 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: finished, as of the sponsor's last update on 7 Aug 2024. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 1 site in United Kingdom. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

Are results available for this study?

Yes. Results are posted in the registry (first posted 25 Feb 2021). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Major Adverse Cardiac and Cerebrovascular Events (time frame: Hospital discharge or 28 days following PCI, whichever occurs sooner). It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT00910481, which also lists 3 linked publications.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 7 Aug 2024.