Angina Pectoris, Coronary Heart Disease
Conditions
Keywords
Angina, Coronary Heart Disease, Computed Tomography, Angiogram, Coronary Artery Calcium Score, Chest Pain, Angina Pectoris due to Coronary Heart Disease
Brief summary
The primary objective of the study is to see if coronary artery calcium score and computed tomography coronary angiogram alters the proportion of patients diagnosed with angina due to coronary heart disease.
Detailed description
Rapid access chest pain clinics have facilitated the early diagnosis and treatment of patients with coronary heart disease and angina. Despite this important service provision, coronary heart disease continues to be under-diagnosed and many patients are left untreated and at risk. Recent advances in imaging technology have now led to the widespread use of non-invasive computed tomography both to measure coronary artery calcium scores and undertake coronary angiography. However, this technology has not been robustly evaluated in any systematic approach. Using state-of-the-art multidetector computed tomography scanners, we propose to undertake a major multicentre randomized controlled trial to assess the added value of computed tomography imaging in over 4000 patients attending rapid access chest pain clinics across Scotland. This will define the most appropriate use of this emerging technology in the setting of diagnosing and treating patients with coronary heart disease and angina pectoris. This study will also lay the foundation for future studies to look at the potential prognostic value of this technology.
Interventions
PROCEDUREComputer Tomography Angiography
Computed Tomography Angiography
Sponsors
NHS Lothian
Chief Scientist Office of the Scottish Government
University of Edinburgh
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
DIAGNOSTIC
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
18 Years to 75 Years
Healthy volunteers
No
Inclusion criteria
* 18 and ≤75 years of age * Attendance at the Rapid Access Chest Pain Clinic
Exclusion criteria
* Inability or unwilling to undergo computed tomography scanning, such as exceeding weight tolerance of scanner * Severe renal failure (serum creatinine \>200 µmol/L or estimated glomerular filtration rate \<30 mL/min) * Previous recruitment to the trial * Major allergy to iodinated contrast agent * Unable to give informed consent * Known pregnancy * Acute coronary syndrome within 3 months
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Proportion of patients diagnosed with angina pectoris secondary to coronary heart disease | 6 weeks |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Symptoms | Baseline, after computed tomography scan (where appropriate), 6 weeks and 6 months | (i) Chest pain. (ii) Quality of life. |
| Diagnosis | Baseline, after computed tomography scan (where appropriate), 6 weeks and 6 months | (i) Diagnosis and severity of coronary heart disease (ii) Accuracy of computed tomography coronary angiography |
| Investigations | Baseline, 6 weeks, 6 months | (i) Exercise electrocardiographic stress test (ii) Nuclear medicine imaging - myocardial perfusion imaging (iii) Stress echocardiography (iv) Invasive coronary angiography (v) Non-coronary investigations |
| Treatment | Baseline, after computed tomography scan (where appropriate), 6 weeks, 6 months | (i) Secondary prevention (ii) Pharmacological anti-anginal therapy (iii) Coronary revascularisation |
| Long-term outcome | 10 years | (i) Coronary heart disease death or non-fatal Myocardial Infarction (MI) (ii) Coronary heart disease death (iii) Non-fatal MI (iv) Coronary heart disease death, non-fatal MI or non-fatal stroke (v) Non-fatal stroke (vi) All-cause death (vii) Cardiovascular death (viii) Coronary revascularisation; percutaneous coronary intervention or coronary artery bypass graft surgery (ix) Hospitalisation for chest pain including acute coronary syndromes and non-coronary chest pain (x) Hospitalisation for cardiovascular disease including coronary artery disease, cerebrovascular disease and peripheral arterial disease |
Countries
United Kingdom
Outcome results
None listed