Finding the Invasive Haemodynamic Threshold for Symptom Relief in Stable Angina

Last updated: March 4, 2024
Sponsor: Imperial College London
Overall Status: Active - Recruiting

Phase

N/A

Condition

Circulation Disorders

Angina

Acute Pain

Treatment

Rest-angina physiological assessment

Exercise-angina physiological assessment

Clinical Study ID

NCT05459051
P91528
22HH7546
  • Ages > 18
  • All Genders

Study 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 correlate with symptoms of angina for 58 patients measured invasively under experimental conditions.

Eligibility Criteria

Inclusion

Inclusion Criteria:

  • Eligibility for percutaneous coronary intervention (PCI) due to angina orangina-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 thefollowing:
  • Stress echocardiography
  • Cardiac magnetic resonance perfusion
  • Myocardial perfusion scintigraphy
  • Invasive metrics of coronary physiology

Exclusion

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

Study Design

Total Participants: 58
Treatment Group(s): 2
Primary Treatment: Rest-angina physiological assessment
Phase:
Study Start date:
September 01, 2022
Estimated Completion Date:
April 08, 2025

Connect with a study center

  • Mid and South Essex NHS Foundation Trust

    Basildon,
    United Kingdom

    Active - Recruiting

  • Royal Bournemouth and Christchurch Hospitals NHS Foundation Trust

    Bournemouth,
    United Kingdom

    Active - Recruiting

  • Imperial College NHS Trust

    London,
    United Kingdom

    Active - Recruiting

  • Royal Free Hospital NHS Foundation Trust

    London,
    United Kingdom

    Active - Recruiting

  • St George's University Hospitals NHS Foundation Trust

    London,
    United Kingdom

    Active - Recruiting

  • Portsmouth Hospitals NHS Trust

    Portsmouth,
    United Kingdom

    Active - Recruiting

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