Graft Failure and Consequences of Coronary Artery Bypass Graft Surgery

Recruiting

• Conditions: Coronary Artery Bypass; Graft Failure; Coronary Artery Bypass Graft; Coronary Artery Bypass Graft Surgery (CABG)

• Registration Number: NCT06800430
• Lead Sponsor: University of Edinburgh

Brief 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.

Detailed Description

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.

Study Timeline

• Study First Submitted: 2025-01-22
• Study First Submitted QC: 2025-01-28
• Study First Posted: 2025-01-30
• Study Start: 2025-03-28
• Status Verified: 2025-04
• Last Update Submitted: 2025-04-03
• Last Update Posted: 2025-04-06
• Primary Completion: 2027-03-28
• Study Completion: 2027-08-06

Recruitment & Eligibility

• Status: RECRUITING
• Sex: All
• Target Recruitment: 70

Inclusion Criteria

Not provided

Exclusion Criteria

Not provided

Study & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
Platelet activation	3 years	The degree and location of platelet activation within saphenous vein grafts, measured using standard uptake values and tissue-to-background ratios of \[18F\]-GP1.
Fibroblast activation	3 years	The degree and location of fibroblast activation within saphenous vein grafts, measured using standard uptake values and tissue-to-background ratios of \[68Ga\]-FAPI.
Macrophage activation	3 years	The degree and location of macrophage activation within saphenous vein grafts, measured using standard uptake values and tissue-to-background ratios of \[68Ga\]-DOTATATE.

Secondary Outcome Measures

Name	Time	Method
Systemic cardiovascular disease	3 years	The secondary endpoints will include the presence of systemic thrombotic, fibrotic or inflammatory cardiovascular disease, assessed through biomarker and CT imaging analyses.

Trial Locations

Locations (1)

Royal Infirmary of Edinburgh; 🇬🇧 Edinburgh, Midlothian, United Kingdom