Actively Recruiting

Phase Not Applicable
Age: 18Years +
All Genders
NCT07386418

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

Age: 18Years +
All Genders

Eligibility Criteria

Eligible

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
Not Eligible

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

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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

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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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Study of Lesion-Specific Invasive Haemodynamic Angina Thresholds | DecenTrialz