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Health Condition(s) or Problem
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Coronary artery disease
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Lay Summary
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Sorry, not currently available
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Who can enter the trial
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1. Patients over 40 referred to the Rapid Access Chest Pain Clinic (RACPC), Ulster Hospital, Northern Ireland for suspicion of angina
2. Patients must have the ability to hold breath
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Who cannot enter the trial
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1. Less than 40 years of age
2. Significant renal dysfunction with an estimated Glomerular Filtration Rate (eGFR) less than 35. As the contrast used in CCT and conventional angiography can cause contrast nephropathy these patients with will be excluded from the study
3. Recent history of alcohol, drug abuse, or other medical conditions that might compromise safety, successful completion of, or drug compliance during the study
4. Patients with a history of chronic inflammatory conditions, such as severe arthritis, lupus, or inflammatory bowel disease, as well as subjects taking immunosuppressant agents, such as cyclosporine, tacrolimus, azathioprine, or chronic oral glucocorticoids. Because High-Sensitivity C-Reactive Protein (hs-CRP) will be measured, patients with other conditions that may cause a chronically elevated CRP will be excluded.
5. Unstable angina pectoris
6. Uncontrolled fast atrial fibrillation or other arrhythmias that may interfere with ECG-gated triggering of CT
7. Patients with extreme tachycardia, greater than 110 bpm, despite rate controlling agents
8. Pregnancy
9. Morbid obesity (Body Mass Index [BMI] >35)
10. Known contrast medium allergy
11. Known ischaemic heart disease with previous intervention in the form of coronary artery bypass graft (CABG) or percutaneous coronary intervention (PCI)
12. Inability to lie flat.
13. Severe Aortic Stenosis (clinically suspected and confirmed by echocardiogram)
14. Acute myocarditis/pericarditis
15. Uncontrolled hypertension >220/100
16. Severe peripheral vascular disease or impaired immobility
17. Severe mental disability that would impair capacity to consent
18. Significant COPD that would impair exercise or B blocker use
19. Left bundle branch
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What will happen
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Observational Study:
Patients referred to the RACPC in the Ulster Hospital and not excluded by criteria will be considered for the trial. Once in the trial patients will complete questionnaires, have biomarkers taken and be randomised to EST or cardiac CT. The questionnaires to be used will be the established Seattle Angina and EQ-5D questionnaires which, are designed to assess the patients? symptoms and their perceived quality of life. They will be repeated at several points, and will not be altered for this study.
The biomarkers to be used include HDL sub-fractions; HS-CRP; Apolipoprotein A-I; Apolipoprotein A-2; Apolipoprotein B; Apolipoprotein(a) precursor (LPA); Homocysteine; HbA1C; Serum Testosterone; Sex hormone-binding globulin (SHBG); Fasting Insulin.; Lipid soluble anti-oxidants; Ascorbic Acid; Lipoprotein and enzyme status; Serum Amyloid A; Cholesterol ester transfer protein; Interleukin-1; Interleukin-6; Interleukin-10; Alpha Tumor necrosis factor; Lipid Hydroperoxide; F2-isoprostanes; Hepatic lipase.
These will be performed to standard NHS/University protocol.
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Primary aim
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The difference between treatment groups in the change in scores from baseline at 3 months on the physical limitation scale of the SAQ-UK.
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Secondary Aim
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1. The cost effectiveness of cardiac CT as a primary diagnostic strategy will be compared with the costs associated with the current standard of care
2. Health related quality of life
3. Cumulative radiation exposure
4. Resource utilisation
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Participant Information Sheet
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Not available in web format, please use contact details below to request a patient information sheet
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Website
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Sorry, not currently available
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Recruitment Status
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Recruiting
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Nation
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Northern Ireland
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Location
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Belfast
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