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Controlled Trial of High-risk Coronary Intervention With Percutaneous Left Ventricular Unloading (CHIP-BCIS3)

Primary Purpose

Ischemic Heart Disease, Coronary Artery Disease

Status
Recruiting
Phase
Phase 3
Locations
United Kingdom
Study Type
Interventional
Intervention
Percutaneous left ventricular unloading
Sponsored by
Guy's and St Thomas' NHS Foundation Trust
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Ischemic Heart Disease focused on measuring percutaneous coronary intervention, percutaneous left ventricular unloading

Eligibility Criteria

18 Years - undefined (Adult, Older Adult)All SexesDoes not accept healthy volunteers

Inclusion Criteria:

  1. Extensive coronary disease defined by a British Cardiovascular Intervention Society (BCIS) Jeopardy Score ≥ 8*
  2. Severe left ventricular systolic dysfunction defined as a LVEF ≤ 35% (or ≤ 45% in the presence of severe mitral regurgitation)#
  3. Complex PCI defined by the presence of at least one of the following criteria:

    • Unprotected left main intervention in the presence of

      • an occluded dominant right coronary artery, or
      • a left dominant circulation, or
      • disease involving the entire bifurcation (Medina1,1,1 or 0,1,1)
    • Intended calcium modification (by rotational atherectomy, lithotripsy or laser) o inmultiplevesselsor

      • in the left main stem, or
      • in a final patent conduit, or
      • where the anatomic SYNTAX score is ≥32
    • Target vessel is a chronic total occlusion with planned retrograde approach * In general, patients who do not have bypass grafts will be eligible if the patient has at least proximal left anterior descending (LAD) disease or at least proximal 2 vessel disease. For patients with patent bypass grafts, or in cases where the extent of coronary artery disease (CAD) is uncertain, the BCIS-1 JS should be calculated. The maximum possible JS score is 12. N.B. The JS should be based on all coronary disease, not just the vessel subtending viable myocardium.

      • Biplane / 3D echocardiography, or cardiac MRI can be used to assess the qualifying LVEF.

Exclusion Criteria:

  1. Cardiogenic shock or acute STEMI at randomisation
  2. Contraindication to pLVAD insertion
  3. Inability to give informed consent
  4. Previously enrolled in CHIP or current enrolment in another interventional study that may affect CHIP outcomes

Sites / Locations

  • Guy's and St Thomas' NHS Foundation TrustRecruiting

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

No Intervention

Arm Label

LV-unloading

Standard of Care

Arm Description

Participants in the elective unloading (intervention) group will have a percutaneous left ventricular unloading device (pLVAD) inserted at the start of the procedure, before the coronary intervention. Maximal support will be provided throughout the procedure, following which support will be weaned and the device removed should the patient remain haemodynamically stable.

Participants in the control arm will receive the planned high-risk percutaneous coronary intervention as is the current standard of care without elective left ventricular unloading. Alternative mechanical circulatory support devices (such as the intra-aortic balloon pump (IABP) or extracorporeal membrane oxygenation (ECMO) will only be permitted in case of complications.

Outcomes

Primary Outcome Measures

Composite hierarchical outcome analysed using a Win Ratio method.
Events included in the composite hierarchical outcome include: death, stroke, spontaneous myocardial infarction, cardiovascular hospitalisation or periprocedural myocardial infarction.

Secondary Outcome Measures

Individual components of the primary outcome including: death, stroke, spontaneous myocardial infarction, cardiovascular hospitalisation or periprocedural myocardial infarction.
Analysis will include repeated occurrences of these events
Completeness of revascularisation measured by the change in anatomic BCIS-JS score
Completeness of revascularisation measured by the change in anatomic SYNTAX score
Major bleeding (BARC 3 or 5) using the Bleeding Academic Research Consortium (BARC) classification
Vascular complication measured as the incidence of injury to a major artery or vein resulting in either major bleeding, tissue ischaemia/necrosis requiring percutaneous or surgical intervention, or death
Procedural complication measured as the incidence of VT/VF requiring defibrillation, cardiorespiratory arrest, acute pulmonary oedema requiring assisted ventilation or prolonged hypotension
Unplanned revascularisation
Health-related quality of life and functional status measured by the EuroQol 5-Dimension 5-level questionnaire (EQ-5D- 5L)
The EuroQol 5-Dimension 5-level questionnaire (EQ-5D- 5L) measures quality of life and functional status with higher scores indicating better outcomes.
Resource utilisation and cost effectiveness measured by incremental costs
Resource utilisation and cost effectiveness measured by quality-adjusted life years (QALYs)
Resource utilisation and cost effectiveness measured by net monetary benefit

Full Information

First Posted
July 21, 2021
Last Updated
September 27, 2023
Sponsor
Guy's and St Thomas' NHS Foundation Trust
Collaborators
London School of Hygiene and Tropical Medicine, The Queen Elizabeth Hospital, The Royal Bournemouth Hospital, St. George's Hospital, London, King's College Hospital, London, King's College London, Royal Victoria Hospital, Belfast, Bristol Heart Institute, Leeds General Infirmary, Freeman Hospital, Newcastle, Barts Heart Centre, London, Glenfield Hospital, Leicester, Morriston Hospital, Swansea, St Thomas' Hospital, London, Royal Sussex County Hospital, New Cross Hospital, Wolverhampton
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1. Study Identification

Unique Protocol Identification Number
NCT05003817
Brief Title
Controlled Trial of High-risk Coronary Intervention With Percutaneous Left Ventricular Unloading
Acronym
CHIP-BCIS3
Official Title
Controlled Trial of High-risk Coronary Intervention With Percutaneous Left Ventricular Unloading
Study Type
Interventional

2. Study Status

Record Verification Date
February 2023
Overall Recruitment Status
Recruiting
Study Start Date
August 6, 2021 (Actual)
Primary Completion Date
June 30, 2025 (Anticipated)
Study Completion Date
June 30, 2026 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Guy's and St Thomas' NHS Foundation Trust
Collaborators
London School of Hygiene and Tropical Medicine, The Queen Elizabeth Hospital, The Royal Bournemouth Hospital, St. George's Hospital, London, King's College Hospital, London, King's College London, Royal Victoria Hospital, Belfast, Bristol Heart Institute, Leeds General Infirmary, Freeman Hospital, Newcastle, Barts Heart Centre, London, Glenfield Hospital, Leicester, Morriston Hospital, Swansea, St Thomas' Hospital, London, Royal Sussex County Hospital, New Cross Hospital, Wolverhampton

4. Oversight

Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Product Manufactured in and Exported from the U.S.
No
Data Monitoring Committee
Yes

5. Study Description

Brief Summary
Over 100,000 coronary stent procedures, where small balloons are used to stretch open a narrowed blood vessel, are performed every year in the United Kingdom 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-BCIS3 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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Ischemic Heart Disease, Coronary Artery Disease
Keywords
percutaneous coronary intervention, percutaneous left ventricular unloading

7. Study Design

Primary Purpose
Treatment
Study Phase
Phase 3
Interventional Study Model
Parallel Assignment
Masking
None (Open Label)
Allocation
Randomized
Enrollment
250 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title
LV-unloading
Arm Type
Experimental
Arm Description
Participants in the elective unloading (intervention) group will have a percutaneous left ventricular unloading device (pLVAD) inserted at the start of the procedure, before the coronary intervention. Maximal support will be provided throughout the procedure, following which support will be weaned and the device removed should the patient remain haemodynamically stable.
Arm Title
Standard of Care
Arm Type
No Intervention
Arm Description
Participants in the control arm will receive the planned high-risk percutaneous coronary intervention as is the current standard of care without elective left ventricular unloading. Alternative mechanical circulatory support devices (such as the intra-aortic balloon pump (IABP) or extracorporeal membrane oxygenation (ECMO) will only be permitted in case of complications.
Intervention Type
Device
Intervention Name(s)
Percutaneous left ventricular unloading
Intervention Description
Percutaneous left ventricular unloading involves the placement of a mechanical pump which draws blood from the left ventricle and returns it into the aorta at flow rates approaching native cardiac output.
Primary Outcome Measure Information:
Title
Composite hierarchical outcome analysed using a Win Ratio method.
Description
Events included in the composite hierarchical outcome include: death, stroke, spontaneous myocardial infarction, cardiovascular hospitalisation or periprocedural myocardial infarction.
Time Frame
Minimum 12-months of follow-up, up to 4 years
Secondary Outcome Measure Information:
Title
Individual components of the primary outcome including: death, stroke, spontaneous myocardial infarction, cardiovascular hospitalisation or periprocedural myocardial infarction.
Description
Analysis will include repeated occurrences of these events
Time Frame
Minimum 12-months of follow-up, up to 4 years
Title
Completeness of revascularisation measured by the change in anatomic BCIS-JS score
Time Frame
Between baseline and the completion of the final planned PCI procedure assessed up to 90 days post-randomisation
Title
Completeness of revascularisation measured by the change in anatomic SYNTAX score
Time Frame
Between baseline and the completion of the final planned PCI procedure assessed up to 90 days post-randomisation
Title
Major bleeding (BARC 3 or 5) using the Bleeding Academic Research Consortium (BARC) classification
Time Frame
Up to 90 days post-randomisation
Title
Vascular complication measured as the incidence of injury to a major artery or vein resulting in either major bleeding, tissue ischaemia/necrosis requiring percutaneous or surgical intervention, or death
Time Frame
At discharge from each planned percutaneous coronary intervention procedure up to 90 days post-randomisation
Title
Procedural complication measured as the incidence of VT/VF requiring defibrillation, cardiorespiratory arrest, acute pulmonary oedema requiring assisted ventilation or prolonged hypotension
Time Frame
At discharge from each planned percutaneous coronary intervention procedure up to 90 days post-randomisation
Title
Unplanned revascularisation
Time Frame
Up to 90 days post-randomisation
Title
Health-related quality of life and functional status measured by the EuroQol 5-Dimension 5-level questionnaire (EQ-5D- 5L)
Description
The EuroQol 5-Dimension 5-level questionnaire (EQ-5D- 5L) measures quality of life and functional status with higher scores indicating better outcomes.
Time Frame
90 days and 1 year post-randomisation
Title
Resource utilisation and cost effectiveness measured by incremental costs
Time Frame
At 12-months post-randomisation
Title
Resource utilisation and cost effectiveness measured by quality-adjusted life years (QALYs)
Time Frame
At 12-months post-randomisation
Title
Resource utilisation and cost effectiveness measured by net monetary benefit
Time Frame
At 12-months post-randomisation

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria: Extensive coronary disease defined by a British Cardiovascular Intervention Society (BCIS) Jeopardy Score ≥ 8* Severe left ventricular systolic dysfunction defined as a LVEF ≤ 35% (or ≤ 45% in the presence of severe mitral regurgitation)# Complex PCI defined by the presence of at least one of the following criteria: Unprotected left main intervention in the presence of an occluded dominant right coronary artery, or a left dominant circulation, or disease involving the entire bifurcation (Medina1,1,1 or 0,1,1) Intended calcium modification (by rotational atherectomy, lithotripsy or laser) o inmultiplevesselsor in the left main stem, or in a final patent conduit, or where the anatomic SYNTAX score is ≥32 Target vessel is a chronic total occlusion with planned retrograde approach * In general, patients who do not have bypass grafts will be eligible if the patient has at least proximal left anterior descending (LAD) disease or at least proximal 2 vessel disease. For patients with patent bypass grafts, or in cases where the extent of coronary artery disease (CAD) is uncertain, the BCIS-1 JS should be calculated. The maximum possible JS score is 12. N.B. The JS should be based on all coronary disease, not just the vessel subtending viable myocardium. Biplane / 3D echocardiography, or cardiac MRI can be used to assess the qualifying LVEF. Exclusion Criteria: Cardiogenic shock or acute STEMI at randomisation (including current treatment with a mechanical circulatory support device) Contraindication to pLVAD insertion Inability to give informed consent Previously enrolled in CHIP or current enrolment in another interventional study that may affect CHIP outcomes
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Trial Manager
Phone
02079272723
Email
CHIP-BCI3@LSHTM.ac.uk
First Name & Middle Initial & Last Name or Official Title & Degree
Matt Ryan
Email
matthew.ryan@kcl.ac.uk
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Divaka Perera
Organizational Affiliation
KCL, GSTT
Official's Role
Principal Investigator
Facility Information:
Facility Name
Guy's and St Thomas' NHS Foundation Trust
City
London
ZIP/Postal Code
SE1 7EH
Country
United Kingdom
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
R&D Office
Email
R&D@gstt.nhs.uk

12. IPD Sharing Statement

Plan to Share IPD
Undecided

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Controlled Trial of High-risk Coronary Intervention With Percutaneous Left Ventricular Unloading

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