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CHIP-BCIS3

A trial to investigate whether a heart pump improves the safety and effectiveness of high-risk coronary artery stenting procedures.

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About

CHIP-BCIS3 is a 6-year research study, based in the UK which began in July 2020. The study aims to recruit 250 participants who are undergoing high-risk coronary artery stenting procedures. The aim of the research is to understand whether the use of a heart pump device impacts the safety and effectiveness of the high-risk stenting procedure. This will be evaluated using a randomised controlled trial study design. 

About
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About the study

Over 100,000 coronary stent procedures, where small balloons are used to stretch open a narrowed blood vessel, are performed every year in the UK to treat people who have conditions such as angina or have suffered a heart attack.

For most patients the risk of complications is low, but for some, there is a higher risk of their heart failing during the procedure. Heart failure is a serious complication which can need treatment with a life support machine and lead to major damage to the heart muscle or even death. These risks are greatest in patients with severely diseased heart arteries and those who already have weakened heart muscle.

A new technology may be able to help with this problem. It consists of a small heart pump which is placed in the heart’s main pumping chamber (the left ventricle, LV). This pump is known as a LV unloading device. The LV unloading device is inserted into the heart through a blood vessel in the leg and supports the heart muscle. It is removed at the end of the procedure or when the heart can pump safely on its own. Whilst this heart pump is promising, it comes with some risks of its own. These include bleeding and damage to the arteries in the legs. It is also expensive, costing £8,000 per operation. Currently, there is no strong evidence to guide the use of this device.

The CHIP study aims to determine whether these heart pumps are beneficial and cost-effective in patients receiving a stenting procedure who are at high-risk of complications.

Who can participate?

This study is open to patients who are due to receive a Percutaneous Coronary Intervention (PCI), or stenting, to treat narrow arteries in their heart and whose doctor believes they are at high-risk of complications.

How long will the study run for?

CHIP-BCIS3 will open to recruitment in summer 2021 and recruit participants for 3 years. The results of this important study are expected in 2026.

For more information, please email CHIP-BCIS3@LSHTM.ac.uk.

Who we are

CHIP-BCIS3 is a collaboration between King’s College London, Guy’s and St Thomas’ NHS Foundation Trust and the London School of Hygiene & Tropical Medicine.

CHIP-BCIS3 Profiles

Divaka Perera

Professor and Chief Investigator, King’s College London and St Thomas’ Hospital

Tim
Clayton

Professor
Principle Investigator

Matt Ryan

Clinical Research Fellow, King’s College London and St Thomas’ Hospital

Richard Evans

Senior Manager of the Clinical Trials Unit

Alexander
Perkins

Research Fellow
Senior Trial Manager

Steven Robertson

Senior Data Manager

Laura van Dyck

Data Manager

Lynn Laidlaw

Patient Representative
Resources
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CHIP-BCIS3 Trial Protocol

Vie the CHIP-BCIS3 Trial Protocol.

CHIP-BCIS3 Participant Information Sheet

View the CHIP-BCIS3 Participant Information Sheet.

CHIP-BCIS3 Consent Form

View the CHIP-BCIS3 Consent Form.

Publications
Publications
Please check back later for publications related to CHIP-BCIS3.
Training for sites
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Randomisation system guidance

View the Randomisation system guidance.

Newsletters
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Please check back later for CHIP-BCIS3 newsletters.