Stable Angina
Conditions
Keywords
Stable Angina
Brief summary
ORBITA-2 is a double blinded randomised placebo-controlled trial comparing the effects of coronary angioplasty versus placebo procedure on symptoms of stable angina without background anti-anginal therapy. Follow-up will be at 12 weeks.
Interventions
PROCEDUREPercutaneous coronary intervention
Percutaneous coronary intervention with drug-eluting stents aiming to achieve complete revascularisation
Sponsors
Basildon and Thurrock Hospitals NHS FoundationTrust
Imperial College London
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
QUADRUPLE (Subject, Caregiver, Investigator, Outcomes Assessor)
Eligibility
Sex/Gender
ALL
Age
18 Years to 85 Years
Healthy volunteers
No
Inclusion criteria
ORBITA-2 will enrol patients who meet all 3 of the following criteria: 1. Angina or angina-equivalent symptoms 2. Anatomical evidence of significant coronary stenosis in at least one vessel, either: a. Invasive diagnostic coronary angiogram indicating ≥ 70% stenosis b. CT coronary angiography indicating ≥ 90% stenosis 3. Evidence of ischaemia, arising from at least one of the following options: 1. Positive dobutamine stress echocardiography 2. Positive cardiac MRI perfusion scan 3. Positive nuclear medicine myocardial perfusion scan 4. Invasive pressure wire assessment suggestive of ischaemia, as judged by the interventional cardiologist, at the time of diagnostic angiogram or research angiogram
Exclusion criteria
1. Age younger than 18 2. Age older than 85 3. Recent acute coronary event 4. Previous coronary artery bypass graft surgery 5. Significant left main stem coronary disease 6. Chronic total occlusion in the target vessel 7. Contraindication to percutaneous coronary intervention or drug-eluting stent implantation 8. Contraindication to antiplatelet therapy 9. Severe valvular disease 10. Severe LV systolic impairment 11. Severe respiratory disease 12. Life expectancy less than 2 years, pregnancy, unable to consent
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Change in angina symptom score between groups | 12 weeks |
Secondary
| Measure | Time frame |
|---|---|
| Angina severity as assessed by Canadian Cardiovascular Society class | 12 weeks |
| Physical limitation, angina stability, quality of life, angina frequency, freedom from angina as assessed with the Seattle Angina Questionnaire | 12 weeks |
| Quality of life as assessed with the EQ-5D-5L questionnaire | 12 weeks |
| Change in treadmill exercise time | 12 weeks |
| Need for anti-anginal medication introduction and up-titration | 12 weeks |
| Admission for acute coronary syndrome or unscheduled coronary angiography | 12 weeks |
| Change in dobutamine stress echocardiography score | 12 weeks |
Countries
United Kingdom
Outcome results
None listed