Vein Graft Failure and Cardiovascular Consequences of Coronary Artery Bypass Graft Surgery
试验速览
- 阶段
- 不适用
- 状态
- 招募中
- 入组人数
- 70
- 试验地点
- 1
- 主要终点
- Platelet activation
研究概览
简要总结
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:
- Total-body Positron Emission Tomography and Computed Tomography (PET-CT) scan
- Ultrasound scan of the heart (echocardiogram)
- 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.
详细描述
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.
研究设计
- 研究类型
- Observational
- 观察模型
- Cohort
- 时间视角
- Prospective
入排标准
- 年龄范围
- 18 Years 至 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •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
排除标准
- •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,
- •Known allergy or contraindications to iodinated contrast or radiotracer
- •Patients who are unable to tolerate the supine position
- •Patients who are unable to provide informed consent
研究组 & 干预措施
Cohort 1: Patients undergoing CABG surgery
40 patients (maximum 120) undergoing CABG surgery with multi-vessel disease and at least one saphenous vein graft.
干预措施: Hybrid [18F]-GP1, [68Ga]-DOTATATE, [68Ga]-FAPI total-body positron emission tomography and coronary computed tomography coronary angiography (Radiation)
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.
干预措施: Hybrid [18F]-GP1, [68Ga]-DOTATATE, [68Ga]-FAPI total-body positron emission tomography and coronary computed tomography coronary angiography (Radiation)
结局指标
主要结局
Platelet activation
时间窗: 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
时间窗: 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
时间窗: 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.
次要结局
- Systemic cardiovascular disease(3 years)