Status:

UNKNOWN

Finding the Invasive Haemodynamic Threshold for Symptom Relief in Stable Angina

Lead Sponsor:

Imperial College London

Collaborating Sponsors:

Royal Free Hospital NHS Foundation Trust

Mid and South Essex NHS Foundation Trust

Conditions:

Stable Angina

Eligibility:

All Genders

18+ years

Brief Summary

ORBITA-FIRE is a randomised, double-blinded, placebo controlled experimental study that will identify the fractional flow reserve (FFR) and non-hyperemic pressure ratio (NHPR) thresholds that correlat...

Eligibility Criteria

Inclusion Criteria:

  • Eligibility for percutaneous coronary intervention (PCI) due to angina or angina-equivalent symptoms on exertion

  • Anatomical evidence of significant single-vessel coronary stenosis defined by either:

    • ≥70% stenosis on invasive coronary angiography (ICA)
    • Severe stenosis on CT coronary angiography (CTCA)
  • Physiological evidence of ischaemia with a positive test on at least one of the following:

    • Stress echocardiography
    • Cardiac magnetic resonance perfusion
    • Myocardial perfusion scintigraphy
    • Invasive metrics of coronary physiology

Exclusion Criteria:

  • Age <18 years
  • Recent acute coronary syndrome
  • Previous coronary artery by-pass graft
  • Significant left main stem disease
  • Multivessel disease (defined as >50% angiographic stenosis in other vessels)
  • Chronic total occlusion in the target artery
  • Moderate to severe valvular disease
  • Moderate to severe left ventricular impairment
  • Chronotropic incompetence with a pacemaker
  • Contraindication to PCI or a drug-eluting stents
  • Contraindication to antiplatelet therapy
  • Contraindication to adenosine
  • Moderate to severe respiratory disease
  • Physical inability to exercise
  • Pregnant
  • Inability to consent

Key Trial Info

Start Date :

September 1 2022

Trial Type :

OBSERVATIONAL

Allocation :

ESTIMATED

End Date :

April 8 2025

Estimated Enrollment :

58 Patients enrolled

Trial Details

Trial ID

NCT05459051

Start Date

September 1 2022

End Date

April 8 2025

Last Update

March 6 2024

Active Locations (6)

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Page 1 of 2 (6 locations)

1

Mid and South Essex NHS Foundation Trust

Basildon, United Kingdom

2

Royal Bournemouth and Christchurch Hospitals NHS Foundation Trust

Bournemouth, United Kingdom

3

Imperial College NHS Trust

London, United Kingdom

4

Royal Free Hospital NHS Foundation Trust

London, United Kingdom