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Finding the Invasive Haemodynamic Threshold for Symptom Relief in Stable Angina

RECRUITINGSponsored by Imperial College London
Actively Recruiting
SponsorImperial College London
Started2022-09-01
Est. completion2025-04-08
Eligibility
Age18 Years+
Healthy vol.Accepted

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

Age: 18 Years+Healthy volunteers accepted
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

Conditions2

Heart DiseaseStable Angina

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