At a glance
- What the study gets you
- Health checks and monitoring — no treatment given
- Type of study
- Observational (no treatment given)
- Time in hospital
- In-person visits at study sites — visit count not specified by the sponsor
- Drug or intervention
- Coronary artery bypass grafting surgery (CABG) (procedure)
- How long the study runs
- Study runs about 52 months (dates as stated)
- About the drug or intervention
- Coronary artery bypass grafting surgery (CABG) — procedure: Patients with MVCAD will undergo CABG as per standard of care.
- Patient visit burden
- Not specified by the sponsor
- Type of study
- Observing health over time
- Ages
- 25 Years to 80 Years
- Who
- All
- Number of participants
- 100
- Started
- 2022-04-25
- Last checked
- 2023-11
Plain English Summary
What is this study?
- • Testing a new treatment for ischaemic heart disease
- • Clinical study - 100 participants
- • 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
Who can take part?
- • Ages 25 Years to 80 Years
- • Diagnosed with ischaemic heart disease
Where?
- • London - Imperial College Healthcare NHS Trust - Hammersmith Hospital
This is a simplified summary. Always discuss with your doctor before making any decisions.
About This Trial
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.
More detail
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.
How this trial compares with your answers
Answer 2 more questions to improve match
What we know so far
Still need:
- • Tell us your age for better matching
- • Tell us your sex for better matching
Preliminary match based on your answers. Full eligibility requires on-site assessment including medical history, physical exam, and lab tests. This does not guarantee enrolment.
Eligibility at a Glance
Key info
- Age: 25 Years - 80 Years
- Who can join: All genders
What the study is looking for
- ✓INCLUSION CRITERIA
- ✓Age of 25 to 80 years of age
- ✓Willing to participate and able to understand, read and sign the agreement to take part form (ICF) before the usual treatment...
- ✓Undergoing isolated first-time elective CABG surgery
- ✓Available pre-operative angiography data with iFR measurements done during the pre-operative angiography
See the full criteria
Where Is This Study? (1 UK site)
Imperial College Healthcare NHS Trust - Hammersmith Hospital
London W12 0HS, United Kingdom
How to Get in Touch
Prakash P Punjabi, MBBS,MCh,FRCS,FFST,FESC,FCCP
Sponsor contactCONTACT
Panagiotis G Kyriazis, BSc, MRes
Sponsor contactCONTACT
