Stable chest pain Circulatory System
Conditions
Interventions
People who come to the hospital outpatients department with stable new-onset chest pain or those that have been admitted to cardiology wards will be approached to take part in the trial. If they take
Sponsors
University of Leeds
Eligibility
Sex/Gender
All
Inclusion criteria
Inclusion criteria: 1. Males =45 years or females =50 years 2. Atypical or typical angina 3. At least one major cardiac risk factor (diabetes, peripheral arterial disease, cerebrovascular disease, current or past tobacco use, hypertension, dyslipidaemia or family history of premature coronary artery disease) 4. Referred to NHS cardiology outpatient services 5. Requiring further investigation according to NICE CG95 guidelines 6. Deemed suitable for coronary revascularisation if required
Exclusion criteria
Exclusion criteria: In order to keep the trial generalisable to the UK population at large, only issues related to patient safety/appropriateness will form the exclusion criteria; these will include: 1. Prior normal CT coronary angiography (CTCA) within the last 2 years or prior CTCA with extensive calcification 2. Clinically unstable cardiac symptoms 3. Known coronary artery disease (including previous myocardial infarction [MI], acute coronary syndrome [ACS] or coronary revascularization) 4. Contraindication to CTCA or functional cardiac imaging 5. Pregnancy and/or breastfeeding 6. Known chronic renal failure (eGFR < 30ml/min/1.73m²) 7. Inability to give written informed consent
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Time to composite endpoint of cardiovascular death, myocardial infarction, unobstructive coronary artery disease (CAD) at invasive angiography, defined as the invasive reference standard FFR measurement of >0.80 (or instantaneous wave-free ratio [iFR] =0.90), i.e. no functional ischaemia, at the time of coronary angiography (or no coronary stenosis >70% on quantitative coronary angiography should FFR/iFR be deemed clinically inappropriate/unsafe to perform) | — |
Secondary
| Measure | Time frame |
|---|---|
| 1. Patient-reported quality of life measured using the Seattle Angina Questionnaire (SAQ), Euroqol EQ-5D-5L, SF12v2 at 0, 6 and 12 months 2. Guideline-directed medical therapy (GDMT) usage measured using patient questionnaire results and/or GP records at 0, 6 and 12 months 3. Major Adverse Cardiovascular Events (all cause death, myocardial infarction [MI], unplanned percutaneous coronary intervention [PCI]/coronary artery bypass graft surgery [CABG]) measured using patient questionnaire results and/or GP records at 3 years 4. Resource use and cost efficiency measured using patient questionnaire results and/or GP records at 12 months | — |
Countries
England, Scotland, United Kingdom
Contacts
Public ContactLaura Jones
Outcome results
None listed