A double-blind, randomised, placebo-controlled trial of the coronary sinus Reducer in refractory angina: design and rationale of the ORBITA-COSMIC trial
Study context
- Population
- Patients with established epicardial CAD and refractory angina on maximally tolerated antianginal medication, with myocardial ischaemia and no further PCI or CABG options
- Planned comparison
- Coronary sinus Reducer vs placebo procedure
- Primary endpoint
- Stress myocardial blood flow on cardiac magnetic resonance (CMR)
- Follow-up
- 6 months
Methodological detailsdouble-blind, placebo-controlled, Daily symptom recording on a smartphone application, 2-week symptom assessment phase before randomisation in the catheterisation laboratory, Prespecified subgroup undergoes invasive coronary physiology assessment at prerandomisation and follow-up
- Double-blind
- Placebo-controlled
- Daily symptom recording on a smartphone application
- 2-week symptom assessment phase before randomisation in the catheterisation laboratory
- Prespecified subgroup undergoes invasive coronary physiology assessment at prerandomisation and follow-up
No results yet. This paper sets out the design of a trial; its results are to come.
Original publication
A double-blind, randomised, placebo-controlled trial of the coronary sinus Reducer in refractory angina: design and rationale of the ORBITA-COSMIC trial. EuroIntervention. Published 5 February 2024. doi:10.
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