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| ID | Type | Description | Link |
|---|---|---|---|
| SS/CH/09/002 | Other Grant/Funding Number | British Heart Foundation |
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| Name | Class |
|---|---|
| NHS Lothian | OTHER_GOV |
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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:
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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Cohort 1: Patients undergoing CABG surgery | 40 patients (maximum 120) undergoing CABG surgery with multi-vessel disease and at least one saphenous vein graft. |
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| 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. |
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| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Hybrid [18F]-GP1, [68Ga]-DOTATATE, [68Ga]-FAPI total-body positron emission tomography and coronary computed tomography coronary angiography | Radiation | 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. |
| Measure | Description | Time Frame |
|---|---|---|
| Platelet activation | The degree and location of platelet activation within saphenous vein grafts, measured using standard uptake values and tissue-to-background ratios of [18F]-GP1. | 3 years |
| Fibroblast activation | The degree and location of fibroblast activation within saphenous vein grafts, measured using standard uptake values and tissue-to-background ratios of [68Ga]-FAPI. | 3 years |
| Macrophage activation | The degree and location of macrophage activation within saphenous vein grafts, measured using standard uptake values and tissue-to-background ratios of [68Ga]-DOTATATE. | 3 years |
| Measure | Description | Time Frame |
|---|---|---|
| Systemic cardiovascular disease | The secondary endpoints will include the presence of systemic thrombotic, fibrotic or inflammatory cardiovascular disease, assessed through biomarker and CT imaging analyses. | 3 years |
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INCLUSION CRITERIA:
Cohort 1: Patients undergoing CABG surgery
Cohort 2: Patients with symptomatic saphenous vein graft vasculopathy
EXCLUSION CRITERIA:
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We will recruit two populations of patients following CABG surgery. Participants will be prospectively recruited following CABG surgery (cohort 1), or identification of clinically suspected saphenous vein graft failure (cohort 2). Recruitment will for both cohorts will be from a single, tertiary centre (Royal Infirmary of Edinburgh).
| Name | Role | Phone | Extension | |
|---|---|---|---|---|
| Laura E Clark, BSc, MBChB, MRCS(Ed) | Contact | +447717478087 | lclark15@ed.ac.uk | |
| David E Newby, BSc (Hons) PhD BM DM DSc FRCP | Contact | d.e.newby@ed.ac.uk |
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| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Royal Infirmary of Edinburgh | Recruiting | Edinburgh | Midlothian | EH16 4SA | United Kingdom |
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Venous blood samples (up to 60ml)
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| Hybrid [18F]-GP1, [68Ga]-DOTATATE, [68Ga]-FAPI total-body positron emission tomography and coronary computed tomography coronary angiography | Radiation | 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. |
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| ID | Term |
|---|---|
| D002318 | Cardiovascular Diseases |
| D006331 | Heart Diseases |
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| ID | Term |
|---|---|
| C499142 | Ga(III)-DOTATOC |
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