Ischaemic Heart DiseaseiCABGNCT04014140
iFR Guided Coronary Artery Bypass Grafting Surgery
An observational study of Ischaemic Heart Disease and Coronary Artery Disease, run by Prakash Punjabi at 1 site in United Kingdom.
Trial summary
The expected outcome of better and improved patency of bypass grafts and its direct relation to pre-operative iFR measurements of stenosis as compared to direct visual physiology of stenosis in the coronary angiogram. Read more about this study
- Who is it for?
- Ages 25 to 80 years
- Conditions the study is for
- Ischaemic Heart Disease, Coronary Artery Disease, Coronary Stenosis
- What is being tested?
- Coronary artery bypass grafting surgery (CABG)
- Type of treatment
- Surgery or procedure
- How many people
- 100 participants
- Where
- 1 siteUnited Kingdom
- Study dates
- 25 Apr 2022to 31 Aug 2026
- Phase
- Observational
- Are there results?
- None posted in the registry
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 25 to 80 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Study population: Retrospective cohort study - approximately 250 pts Prospective cohort study - minimum 28 pts - maximum 100 pts
Who may be able to join
- Age of 25 to 80 years of age
- Willing to participate and able to understand, read and sign the informed consent form (ICF) before standard of care elective CABG surgery
- Undergoing isolated first-time elective CABG surgery
- Available pre-operative angiography data with iFR measurements done during the pre-operative angiography
Who cannot join
- Emergency CABG surgery
- Ejection Fraction≤ 40%
- Severe valvular heart disease
Trial locations and contacts
1 site in 1 country.
Prakash P Punjabi, MBBS,MCh,FRCS,FFST,FESC,FCCP contact
United Kingdom1 site, 1 recruiting
- Recruiting
Imperial College Healthcare NHS Trust - Hammersmith Hospital
London, Greater London, W12 0HS
Becky Ward, 02075949459 ext. +44, becky.ward@imperial.ac.uk
Prakash P Punjabi, MBBS,MCh,FRCS,FFST,FESC,FCCP
About this study
Official title: Long-term Graft Patency Outcomes of LIMA-LAD Post-CABG Surgery Based on iFR Measurements.
The expected outcome of better and improved patency of bypass grafts and its direct relation to pre-operative iFR measurements of stenosis as compared to direct visual physiology of stenosis in the coronary angiogram.
To establish the correlation between the use of intracoronary physiology and improved graft patency at 12 months for patients undergoing CABG surgery.
It is a minimum of 28 and a maximum of 100 patients single-centre proof or concept/ observational study/ pilot study.
Read the detailed description
Patients suffering from coronary artery disease undergo coronary artery bypass grafting surgery (CABG) as the standard of care. The selection of which vessels to bypass is usually at the discretion of the surgeon forming an opinion based on the pre-operative angiographic imaging. Intra-coronary physiology (iFR measurements) is more accurate to determine the level of damage to the coronary arteries; however, currently it is not used for CABG pre-assessment, but only for percutaneous intervention also known as stenting as it has been shown to improve outcomes. Although, the use of intracoronary physiology has not been extensively studied or validated in patients undergoing CABG.
Patients with multi-vessel coronary artery disease (CAD) who are planned for surgical revascularization with coronary artery bypass grafting (CABG), will have iFR measurement taken during invasive coronary angiography as part of standard care, they will undergo CABG and will have echocardiography at 3 months and computed tomography coronary angiography (CTCA) at 12 months.
Early graft failure will be assessed by the presentation of any clinical symptoms, major adverse cardiovascular and cerebrovascular events (MACCE) and echocardiography at 3 months. The endpoint will be graft patency as assessed by CT coronary angiography at 12 months.
Anticipated recruitment is 12-24 months. Follow-up with echocardiography at 3 months and a CTCA at 12 months. Quality of Life questionnaire will be completed by the patient at 3 and 12 months during the follow-up appointment.
Patients will continue on optimal medical therapy. Clinic visit and quality of life scale questionnaires will be recorded at 3 and 12 months and echocardiography will be assessed at 3 months. Graft patency at 12 months will be assessed with a CT coronary angiography.
- Being tested
- Coronary artery bypass grafting surgery (CABG)
- Keywords
- Instantaneous wave-free ratio (iFR), Coronary Artery Bypass Grafting (CABG)
- Medical subject headings
- Coronary Artery Disease, Coronary Stenosis
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Coronary artery bypass grafting surgery (CABG)Procedure or surgery
Patients with MVCAD will undergo CABG as per standard of care.
| Study group | Role | What they receive |
|---|---|---|
| Patients with multi-vessel coronary artery disease (MVCAD) | iFR measurements will be taken pre-operatively during the invasive coronary angiography. Receives: Procedure: Coronary artery bypass grafting surgery (CABG) |
What is being measured
The primary outcome is the main question the study is designed to answer.
Graft patency
The primary endpoint will be graft patency as assessed by CT coronary angiography at 12 months.
Measured: 12 months
Secondary outcomes (8)
Quality of Life Questionnaire
Patient's view in their quality of life
Measured: 3 and 12 months
Composite of MACE (MI, Death, stroke, repeat revascularisation)
Assessed by the presentation of clinical symptoms and echocardiography during a follow-up visit at 3 months or anytime within 12 months.
Measured: 12 months
Any episode of reintervention
Patient undergoing repeat reintervention
Measured: 12 months
Incidence of Myocardial infarction
Assessed by the presentation of clinical symptoms, echocardiography during a follow-up visit at 3 months or anytime within 12 months and in addition, evidence of percutaneous or surgical revascularisation within the last 12 months.
Measured: 12 months
Incidence of Stroke
Assessed by the presentation of clinical symptoms during a follow-up visit at 3 and 12 months or anytime within 12 months.
Measured: 12 months
Left ventricular function at 3 months with an echocardiography
Cardiac functional assessment at 3 months post-opereatively
Measured: 3 months
Incidence of Death (all-cause)
Patient deceased
Measured: 12 months
Incident of Death (cardiovascular)
Patient deceased
Measured: 12 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted10 Jul 2019
- Study start25 Apr 2022
- Primary completion31 Aug 2025 (estimated)
- Study completion31 Aug 2026 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Ischaemic Heart 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
- Observational
- Observational model
- Cohort
- Time perspective
- Prospective
- Enrolment
- 100 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Prakash Punjabi
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor-investigator, Prakash Punjabi, Imperial College Healthcare NHS Trust
- Investigators
- Prakash P Punjabi, MBBS,MCh,FRCS,FFST,FESC,FCCP, Principal investigator, Imperial College Healthcare NHS Trust
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04014140
- Sponsor's protocol ID
- 17HH3875
- Acronym
- iCABG
- Status last verified
- Nov 2023
- First submitted
- 4 Jul 2019
- Last updated
- 21 Nov 2023
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Yes: Anonymised individual participant data for all primary and secondary outcome measures will be made available.
Study at a glance
From the registry record, last updated by the sponsor on 21 Nov 2023. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Long-term Graft Patency Outcomes of LIMA-LAD Post-CABG Surgery Based on iFR Measurements.
- ClinicalTrials.gov ID
- NCT04014140
- Acronym / sponsor ID
- iCABG / 17HH3875
- Keywords
- Instantaneous wave-free ratio (iFR), Coronary Artery Bypass Grafting (CABG)
- Study type
- Observational
- Recruitment status
- Unknown status
- Enrolment
- 100 participants (estimated)
- Lead sponsor
- Prakash PunjabiUniversity, hospital or other
- Study start
- 25 Apr 2022 (actual)
- Primary completion
- 31 Aug 2025 (estimated)
- Study completion
- 31 Aug 2026 (estimated)
- First posted
- 10 Jul 2019 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
The expected outcome of better and improved patency of bypass grafts and its direct relation to pre-operative iFR measurements of stenosis as compared to direct visual physiology of stenosis in the coronary angiogram.
To establish the correlation between the use of intracoronary physiology and improved graft patency at 12 months for patients undergoing CABG surgery.
It is a minimum of 28 and a maximum of 100 patients single-centre proof or concept/ observational study/ pilot study.
Detailed description
Patients suffering from coronary artery disease undergo coronary artery bypass grafting surgery (CABG) as the standard of care. The selection of which vessels to bypass is usually at the discretion of the surgeon forming an opinion based on the pre-operative angiographic imaging. Intra-coronary physiology (iFR measurements) is more accurate to determine the level of damage to the coronary arteries; however, currently it is not used for CABG pre-assessment, but only for percutaneous intervention also known as stenting as it has been shown to improve outcomes. Although, the use of intracoronary physiology has not been extensively studied or validated in patients undergoing CABG.
Patients with multi-vessel coronary artery disease (CAD) who are planned for surgical revascularization with coronary artery bypass grafting (CABG), will have iFR measurement taken during invasive coronary angiography as part of standard care, they will undergo CABG and will have echocardiography at 3 months and computed tomography coronary angiography (CTCA) at 12 months.
Early graft failure will be assessed by the presentation of any clinical symptoms, major adverse cardiovascular and cerebrovascular events (MACCE) and echocardiography at 3 months. The endpoint will be graft patency as assessed by CT coronary angiography at 12 months.
Anticipated recruitment is 12-24 months. Follow-up with echocardiography at 3 months and a CTCA at 12 months. Quality of Life questionnaire will be completed by the patient at 3 and 12 months during the follow-up appointment.
Patients will continue on optimal medical therapy. Clinic visit and quality of life scale questionnaires will be recorded at 3 and 12 months and echocardiography will be assessed at 3 months. Graft patency at 12 months will be assessed with a CT coronary angiography.
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Patients with multi-vessel coronary artery disease (MVCAD) | – | Procedure: Coronary artery bypass grafting surgery (CABG)iFR measurements will be taken pre-operatively during the invasive coronary angiography. |
Who may qualify
- Ages
- 25 to 80 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- Retrospective cohort study - approximately 250 pts Prospective cohort study - minimum 28 pts - maximum 100 pts
Key inclusion criteria (4 listed)
- Age of 25 to 80 years of age
- Willing to participate and able to understand, read and sign the informed consent form (ICF) before standard of care elective CABG surgery
- Undergoing isolated first-time elective CABG surgery
- Available pre-operative angiography data with iFR measurements done during the pre-operative angiography
Key exclusion criteria (3 listed)
- Emergency CABG surgery
- Ejection Fraction≤ 40%
- Severe valvular heart disease
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 |
|---|---|---|
| Coronary artery bypass grafting surgery (CABG)Patients with MVCAD will undergo CABG as per standard of care. | Procedure or surgery | Patients with multi-vessel coronary artery disease (MVCAD) |
Primary outcome
Graft patency
Time frame: 12 months
The primary endpoint will be graft patency as assessed by CT coronary angiography at 12 months.
8 secondary outcomes
Quality of Life Questionnaire
Time frame: 3 and 12 months
Composite of MACE (MI, Death, stroke, repeat revascularisation)
Time frame: 12 months
Any episode of reintervention
Time frame: 12 months
Incidence of Myocardial infarction
Time frame: 12 months
Incidence of Stroke
Time frame: 12 months
Left ventricular function at 3 months with an echocardiography
Time frame: 3 months
Incidence of Death (all-cause)
Time frame: 12 months
Incident of Death (cardiovascular)
Time frame: 12 months
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 21 Nov 2023.
- Individual participant dataSharing planned: Yes. Anonymised individual participant data for all primary and secondary outcome measures will be made available.
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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.
Prakash P Punjabi, MBBS,MCh,FRCS,FFST,FESC,FCCP contact
Prakash P Punjabi, MBBS,MCh,FRCS,FFST,FESC,FCCP principal investigator
Imperial College Healthcare NHS Trust
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Ischaemic Heart Disease and Coronary Artery Disease, run by Prakash Punjabi 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 4 inclusion and 3 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: status not confirmed, as of the sponsor's last update on 21 Nov 2023. 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?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Prakash P Punjabi, MBBS,MCh,FRCS,FFST,FESC,FCCP (020 3313 2026 ext. +44, P.Punjabi@imperial.ac.uk), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Graft patency (time frame: 12 months). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
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 21 Nov 2023.