Vein Graft Failure and Cardiovascular Consequences of Coronary Artery Bypass Graft Surgery

Status: Recruiting
Location: See location...
Intervention Type: Radiation
Study Type: Observational
SUMMARY

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
Participation Requirements
Sex: All
Minimum Age: 18
Healthy Volunteers: f
View:

⁃ 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

Locations
Other Locations
United Kingdom
Royal Infirmary of Edinburgh
RECRUITING
Edinburgh
Contact Information
Primary
Laura E Clark, BSc, MBChB, MRCS(Ed)
lclark15@ed.ac.uk
+447717478087
Backup
David E Newby, BSc (Hons) PhD BM DM DSc FRCP
d.e.newby@ed.ac.uk
Time Frame
Start Date: 2025-03-28
Estimated Completion Date: 2027-08-06
Participants
Target number of participants: 70
Treatments
Cohort 1: Patients undergoing CABG surgery
40 patients (maximum 120) undergoing CABG surgery with multi-vessel disease and at least one saphenous vein graft.
Cohort 2: Patients with symptomatic saphenous vein graft vasculopathy
30 patients with prior CABG surgery (at least 5 years previously) with multi-vessel disease and two or more saphenous vein grafts, who have been referred for invasive coronary angiography due to symptoms and with a high suspicion of graft vasculopathy.
Sponsors
Collaborators: NHS Lothian
Leads: University of Edinburgh

This content was sourced from clinicaltrials.gov