Actively Recruiting
Study of Lesion-Specific Invasive Haemodynamic Angina Thresholds
Led by Imperial College London · Updated on 2026-02-18
60
Participants Needed
6
Research Sites
146 weeks
Total Duration
On this page
Sponsors
I
Imperial College London
Lead Sponsor
S
St George's University Hospitals NHS Foundation Trust
Collaborating Sponsor
AI-Summary
What this Trial Is About
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.
CONDITIONS
Official Title
Study of Lesion-Specific Invasive Haemodynamic Angina Thresholds
Who Can Participate
Eligibility Criteria
You may qualify if you...
- Eligible for PCI due to angina or angina-like symptoms during exercise
- Have two severe narrowings in major coronary arteries with diameter 2.5mm or larger
- Narrowings confirmed by invasive coronary angiography or CT coronary angiography
- Evidence of ischaemia shown by invasive or non-invasive tests such as physiological coronary tests, stress echocardiography, stress cardiac MRI, myocardial perfusion scans, or FFR-CT
You will not qualify if you...
- Under 18 years of age
- Recent acute coronary syndrome within 3 months
- Previous coronary artery bypass surgery
- Significant disease in the left main coronary artery
- Only one lesion suitable for PCI
- Complete blockage of the target artery
- Moderate to severe valve disease
- Left ventricular ejection fraction 40% or less
- Contraindications to PCI, drug-eluting stents, antiplatelet therapy, or adenosine
- PCI done with drug-eluting balloons without stenting
- Unable to exercise on a supine ergometer
- Femoral artery access used
- Pregnancy
- Unable to give informed consent
AI-Screening
AI-Powered Screening
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Trial Site Locations
Total: 6 locations
1
Mid and South Essex NHS Foundation Trust
Basildon, United Kingdom
Not Yet Recruiting
2
University Hospitals Dorset NHS Foundation Trust
Bournemouth, United Kingdom
Not Yet Recruiting
3
Imperial College Healthcare NHS Trust
London, United Kingdom
Actively Recruiting
4
Royal Free London NHS Foundation Trust
London, United Kingdom
Not Yet Recruiting
5
St George's University Hospitals NHS Foundation Trust
London, United Kingdom
Not Yet Recruiting
6
Portsmouth Hospitals University NHS Trust
Portsmouth, United Kingdom
Not Yet Recruiting
Research Team
K
Kayla Chiew, MBBS MRCP
CONTACT
R
Rasha Al-Lamee, MBBS PhD MRCP
CONTACT
How is the study designed?
Study Type
INTERVENTIONAL
Masking
NONE
Allocation
NA
Model
SINGLE_GROUP
Primary Purpose
DIAGNOSTIC
Number of Arms
1
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