iFR Guided Coronary Artery Bypass Grafting Surgery
For patients and families
In plain language
An automatic summary of structured registry data. It is an orientation aid, not a substitute for the official protocol or a physician assessment.
- What is being studied
- The protocol lists: Coronary artery bypass grafting surgery (CABG).
- Who it may be relevant to
- Registry conditions: Ischaemic Heart Disease, Coronary Artery Disease, Coronary Stenosis. Basic parameters: 25 years — 80 years · All.
- What needs checking
- Age, condition and sex are only basic indicators. Prior treatment, laboratory values and other mandatory requirements appear in the eligibility criteria below.
- Where it takes place
- United Kingdom
- Next step
- Save the trial, show it to the treating physician, and confirm current recruitment with the study center. Costs, documents and travel →
Unsure about the terms? Read our patient guide →
Official title
Long-term Graft Patency Outcomes of LIMA-LAD Post-CABG Surgery Based on iFR Measurements.
Overview
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.
Interventions
- Procedure Coronary artery bypass grafting surgery (CABG)
Patients with MVCAD will undergo CABG as per standard of care.
Primary outcome measures
- Graft patency [Time frame: 12 months]
Secondary outcome measures (8)
- 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]
Eligibility criteria
Inclusion criteria
- 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
Exclusion criteria
- Emergency CABG surgery
- Ejection Fraction≤ 40%
- Severe valvular heart disease
Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.
Healthy volunteers: No
Study design
- Observational model
- Cohort
Study locations
United Kingdom · 1 center
- Imperial College Healthcare NHS Trust - Hammersmith Hospital — London
Identifiers
NCT: NCT04014140 · 17HH3875