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
- Hybrid [18F]-GP1, [68Ga]-DOTATATE, [68Ga]-FAPI total-body positron emission tomography and coronary computed tomography coronary angiography (radiation), Hybrid [18F]-GP1, [68Ga]-DOTATATE, [68Ga]-FAPI total-body positron emission tomography and coronary computed tomography coronary angiography (radiation)
- How long the study runs
- Study runs about 29 months (dates as stated)
- About the drug or intervention
- Hybrid [18F]-GP1, [68Ga]-DOTATATE, [68Ga]-FAPI total-body positron emission tomography and coronary computed tomography coronary angiography — radiation: Patients undergo hybrid \[18F\]-GP1, \[68Ga\]-FAPI and \[68Ga\]-DOTATATE total body PET-CT imaging (Biograph Vision Quadra, Siemens) and contrast-enhanced electrocardiogram gated CT coronary angiogram (CTCA), within 28 days (+/- 28 days) of their CABG surgery and again at 12 month follow-up. · Hybrid [18F]-GP1, [68Ga]-DOTATATE, [68Ga]-FAPI total-body positron emission tomography and coronary computed tomography coronary angiography — radiation: Patients undergo hybrid \[18F\]-GP1, \[68Ga\]-FAPI and \[68Ga\]-DOTATATE total body PET-CT imaging (Biograph Vision Quadra, Siemens) and contrast-enhanced electrocardiogram gated CT coronary angiogram (CTCA), prior to their clinical invasive coronary angiography.
- Patient visit burden
- Not specified by the sponsor
- Type of study
- Observing health over time
- Ages
- 18 Years and over
- Who
- All
- Number of participants
- 70
- Started
- 2025-03-28
- Last checked
- 2026-04
Plain English Summary
What is this study?
- • Testing a new treatment for coronary artery bypass
- • Clinical study - 70 participants
- • Coronary artery bypass graft (CABG) surgery is the commonest type of heart operation performed
Who can take part?
- • Ages 18 Years and over
- • Diagnosed with coronary artery bypass
Where?
- • Edinburgh - Royal Infirmary of Edinburgh
This is a simplified summary. Always discuss with your doctor before making any decisions.
About This Trial
Coronary artery bypass graft (CABG) surgery is the commonest type of heart operation performed. During this, arteries or veins (termed 'grafts') are used to supply blood around blockages within the blood vessels that supply the heart. Unfortunately, these grafts can sometimes fail, and patients can also experience complications like heart attacks and strokes, after surgery. It is known that vein grafts are more likely to narrow over time. Additionally, treating vein graft failure is very challenging, as repeat surgery is riskier and procedures to stent open the veins can also fail. However, it is not fully understood why these complications occur. In this study, the investigators will use an imaging technique called a total-body Positron Emission Tomography (PET) scan. This uses special radioactive dyes (radiotracers) to look at what is happening inside vein grafts. With this technique, the investigators will also be able to see what is happening to the heart, brain and wider parts of the body after CABG surgery. This study will aim to recruit 70 participants in total (maximum 150). 40 (maximum of 120) of these participants will have recently undergone CABG surgery and received ≥1 vein graft. The remaining 30 will have undergone CABG surgery ≥5 years ago and will have symptoms suggestive of vein graft failure. The study will last a total of 36 months and will involve participants undertaking the following assessments: 1. Total-body Positron Emission Tomography and Computed Tomography (PET-CT) scan 2. Ultrasound scan of the heart (echocardiogram) 3. A blood test - up to four tablespoons (60 mL) of blood will be taken for immediate testing and the remainder will be stored for future ethically approved studies.
More detail
This is an observational cohort study investigating the role of inflammation, thrombosis and fibrosis in saphenous vein graft failure following CABG surgery. The presence and distribution of these processes will be examined in one cohort overtime (immediately following surgery and at 1 year-follow up) and at one time-point in a second cohort with clinically suspected vein graft failure. Participants in both cohorts will undergo clinical review (including blood sampling), transthoracic echocardiogram and combined total-body positron emission tomography computed tomography (PET-CT) imaging, with 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: 18 Years and over
- Who can join: All genders
What the study is looking for
- ✓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 causing symptoms saphenous vein graft vasculopathy
- ✓Patients who underwent CABG surgery ≥ 5 years prior to recruitment for multivessel disease and received 2 or more...
Who cannot take part
- ✗Patients with a life expectancy of \< 2 years
- ✗kidney 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
See the full criteria
Where Is This Study? (1 UK site)
Royal Infirmary of Edinburgh
Edinburgh EH16 4SA, United Kingdom
How to Get in Touch
Laura E Clark, BSc, MBChB, MRCS(Ed)
Sponsor contactCONTACT
David E Newby, BSc (Hons) PhD BM DM DSc FRCP
Sponsor contactCONTACT