Graft Failure and Consequences of Coronary Artery Bypass Graft Surgery

Trial statusRecruiting
Trial phaseNot listed
Trial typeObservational
Biological sexAll
Age18+
SponsorUniversity of Edinburgh

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.

Eligibility criteria

Qualifiers

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

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

Disqualifiers

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,

Trial design

Treatments tested in this trial

  • Hybrid [18F]-GP1, [68Ga]-DOTATATE, [68Ga]-FAPI total-body positron emission tomography and coronary computed tomography coronary angiography
  • Hybrid [18F]-GP1, [68Ga]-DOTATATE, [68Ga]-FAPI total-body positron emission tomography and coronary computed tomography coronary angiography

Treatment groups

70 Participants
are divided into 2 treatment groups

Sponsors and collaborators