Using iFR measurements to improve bypass surgery outcomes
Long-term Graft Patency Outcomes of LIMA-LAD Post-CABG Surgery Based on iFR Measurements.
Imperial College Healthcare NHS Trust · NCT04014140
This study is testing if measuring blood flow in the heart using a special technique can help improve the success of bypass surgery for people with multiple blocked arteries.
Quick facts
| Study type | Observational |
|---|---|
| Enrollment | 100 (estimated) |
| Ages | 25 Years to 80 Years |
| Sex | All |
| Sponsor | Imperial College Healthcare NHS Trust (other) |
| Locations | 1 site (London, Greater London) |
| Trial ID | NCT04014140 on ClinicalTrials.gov |
What this trial studies
This observational study aims to evaluate the correlation between intra-coronary physiology, specifically instantaneous wave-free ratio (iFR) measurements, and the patency of bypass grafts in patients undergoing coronary artery bypass grafting (CABG) surgery. Patients with multi-vessel coronary artery disease will have iFR measurements taken during pre-operative angiography, followed by CABG surgery. The study will assess early graft failure through clinical symptoms and echocardiography at 3 months, with graft patency evaluated via CT coronary angiography at 12 months. The goal is to determine if iFR can provide better outcomes compared to traditional angiographic assessments.
Who should consider this trial
Good fit: Ideal candidates are patients aged 25 to 80 years with multi-vessel coronary artery disease scheduled for isolated first-time elective CABG surgery.
Not a fit: Patients requiring emergency CABG surgery, those with an ejection fraction of 40% or less, or severe valvular heart disease may not benefit from this study.
Why it matters
Potential benefit: If successful, this approach could lead to improved graft patency and better long-term outcomes for patients undergoing CABG surgery.
How similar studies have performed: While the use of iFR has shown success in percutaneous interventions, its application in CABG has not been extensively validated, making this a novel approach.
Eligibility criteria
Show full inclusion / exclusion criteria
INCLUSION CRITERIA 1. Age of 25 to 80 years of age 2. Willing to participate and able to understand, read and sign the informed consent form (ICF) before standard of care elective CABG surgery 3. Undergoing isolated first-time elective CABG surgery 4. Available pre-operative angiography data with iFR measurements done during the pre-operative angiography EXCLUSION CRITERIA 1. Emergency CABG surgery 2. Ejection Fraction≤ 40% 3. Severe valvular heart disease
Where this trial is running
London, Greater London
- Imperial College Healthcare NHS Trust - Hammersmith Hospital — London, Greater London, United Kingdom (RECRUITING)
Study contacts
- Principal investigator: Prakash P Punjabi, MBBS,MCh,FRCS,FFST,FESC,FCCP — Imperial College Healthcare NHS Trust
- Study coordinator: Prakash P Punjabi, MBBS,MCh,FRCS,FFST,FESC,FCCP
- Email: P.Punjabi@imperial.ac.uk
- Phone: 020 3313 2026
How to participate
- Review the eligibility criteria above with your treating physician.
- Visit the official trial page on ClinicalTrials.gov for the most current contact information and recruitment status.
- Contact the listed study coordinator or principal investigator to request pre-screening. Pre-screening is free and never obligates you to enroll.
Conditions: Ischaemic Heart Disease, Coronary Artery Disease, Coronary Stenosis, Instantaneous wave-free ratio, Coronary Artery Bypass Grafting