About this trial
ORBITA-SOLAR is an invasive physiological cardiac catheterisation study that aims to determine whether different coronary stenoses have different angina thresholds. The angina threshold is defined as the amount of coronary flow reduction required to reproduce symptoms. Sixty patients with symptoms of stable angina and 2 coronary artery stenoses amenable to percutaneous coronary intervention (PCI) will be recruited. This study will use intra-coronary balloon inflation during supine exercise on an ergometer to measure the fractional flow reserve (FFR) and non-hyperemic pressure ratio (NHPR) that relates to angina onset, in real time, at the location of each stenosis.
Eligibility criteria
Qualifiers
Eligibility for PCI due to angina or angina-equivalent symptoms on exertion
≥70% stenosis in a coronary artery with ≥2.5mm diameter, on invasive coronary angiography (ICA)
Severe stenosis in a vessel with ≥2.5mm diameter, on CTCA
Physiological test during invasive coronary angiography (ICA)
Disqualifiers
Age <18 years
Acute coronary syndrome within 3 months
Previous coronary artery bypass graft
Significant left main stem disease
Trial design
Treatments tested in this trial
- Percutaneous coronary intervention (PCI)
- Measurement of the angina threshold
Treatment groups
Sponsors and collaborators
Imperial College London
Lead sponsor
St George's University Hospitals NHS Foundation Trust
Collaborator
Royal Free Hospital NHS Foundation Trust
Collaborator
University Hospitals Dorset NHS Foundation Trust
Collaborator
Mid and South Essex NHS Foundation Trust
Collaborator
Imperial College Healthcare NHS Trust
Collaborator
Chelsea and Westminster NHS Foundation Trust
Collaborator
Guy's and St Thomas' NHS Foundation Trust
Collaborator
Liverpool Heart and Chest Hospital NHS Foundation Trust
Collaborator