RecruitingNCT06800430

Graft Failure and Consequences of Coronary Artery Bypass Graft Surgery

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


Sponsor

University of Edinburgh

Enrollment

70 participants

Start Date

Mar 28, 2025

Study Type

OBSERVATIONAL

Conditions

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

Min Age: 18 Years

Plain Language Summary

Simplified for easier understanding

This study is looking at why vein grafts used in coronary bypass surgery (CABG) sometimes fail over time, and what happens to the heart and arteries when they do. It includes two groups: patients about to have bypass surgery, and patients who had bypass surgery at least 5 years ago and now have symptoms suggesting graft problems. **You may be eligible if...** - You are 18 or older - You are scheduled for coronary bypass surgery using vein grafts (Cohort 1), OR - You had bypass surgery 5+ years ago and are being referred for a coronary angiogram due to recurring symptoms (Cohort 2) **You may NOT be eligible if...** - You are in a heart attack emergency (Cohort 1 only) - You have had previous bypass surgery (Cohort 1) - Your doctor determines the procedure is unsafe for you Talk to your doctor to see if this trial is right for you.

This summary was AI-generated to explain the trial in plain language. It is not medical advice. Always discuss eligibility with your doctor before enrolling in a clinical trial.

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Interventions

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

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.

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

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.


Locations(1)

Royal Infirmary of Edinburgh

Edinburgh, Midlothian, United Kingdom

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NCT06800430


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