Investigating graft failure after heart bypass surgery
Vein Graft Failure and Cardiovascular Consequences of Coronary Artery Bypass Graft Surgery
This study looks at why heart bypass grafts fail by using special scans and tests on people who have had the surgery and those who might have problems with their grafts.
Quick facts
| Study type | Observational |
|---|---|
| Enrollment | 70 (estimated) |
| Ages | 18 Years and up |
| Sex | All |
| Sponsor | University of Edinburgh Academic / other |
| Locations | 1 site (Edinburgh, Midlothian) |
| Trial ID | NCT06800430 on ClinicalTrials.gov |
What this trial studies
This observational cohort study aims to understand the causes of graft failure following coronary artery bypass graft (CABG) surgery. It will utilize total-body Positron Emission Tomography (PET) scans to examine inflammation, thrombosis, and fibrosis in saphenous vein grafts. Participants will be divided into two cohorts: one undergoing CABG surgery and another with suspected vein graft failure. Clinical reviews, blood sampling, echocardiograms, and advanced imaging techniques will be employed to gather comprehensive data over time.
Who should consider this trial
Good fit: Ideal candidates include adults over 18 undergoing CABG surgery with at least one saphenous vein graft or those with suspected graft vasculopathy after previous CABG.
Not a fit: Patients with a life expectancy of less than two years, renal failure, or those on immunosuppressive therapies may not benefit from this study.
Why it matters
Potential benefit: If successful, this study could lead to improved understanding and management of graft failure, potentially enhancing patient outcomes after CABG surgery.
How similar studies have performed: While this approach is innovative, similar studies have shown promise in understanding graft failure, but the specific use of total-body PET imaging in this context is relatively novel.
Eligibility criteria
Show full inclusion / exclusion criteria
INCLUSION CRITERIA: Cohort 1: Patients undergoing CABG surgery * Males and females over 18 years of age * Patients undergoing CABG surgery for multivessel coronary artery disease, who receive at least one saphenous vein graft Cohort 2: Patients with symptomatic saphenous vein graft vasculopathy * Males and females over 18 years of age * Patients who underwent CABG surgery ≥ 5 years prior to recruitment for multivessel disease and received 2 or more saphenous vein grafts * Referred for invasive coronary angiography due to recurrent symptoms and with a high suspicion of graft vasculopathy EXCLUSION CRITERIA: * Patients with a life expectancy of \< 2 years * Renal failure (estimated glomerular filtration rate \<30 mL/min/1.73 m2) * Patients on immunosuppressive therapies * Females of child-bearing age who are pregnant or breastfeeding, * Known allergy or contraindications to iodinated contrast or radiotracer * Patients who are unable to tolerate the supine position * Patients who are unable to provide informed consent
Where this trial is running
Edinburgh, Midlothian
- Royal Infirmary of Edinburgh — Edinburgh, Midlothian, United Kingdom (Recruiting)
Study contacts
- Study coordinator: Laura E Clark, BSc, MBChB, MRCS(Ed)
- Email: lclark15@ed.ac.uk
- Phone: +447717478087
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.