Clinical trial NCT05459051: Finding the Invasive Haemodynamic Threshold for Symptom Relief in Stable Angina
Official title: Finding the Invasive Haemodynamic Threshold for Symptom Relief in Stable Angina
Study type: OBSERVATIONAL
Overall status: RECRUITING
Conditions: Stable Angina
Keywords: Symptoms
Angina
Physiology
Placebo
Lead sponsor: Imperial College London
Sponsor class: OTHER
Collaborators: name: Royal Free Hospital NHS Foundation Trust
name: Mid and South Essex NHS Foundation Trust
name: St George's University Hospitals NHS Foundation Trust
name: Royal Bournemouth and Christchurch Hospitals NHS Foundation Trust
name: Portsmouth Hospitals NHS Trust
First posted: 2022-07-14
Enrollment: 58
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: COHORT
Time perspective: PROSPECTIVE
Sampling method: PROBABILITY_SAMPLE
Study population: Patient with stable angina

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


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

Primary outcomes:
measure: The FFR and NHPR value at which the patient experiences angina in a rest state
timeFrame: Intra-procedural
measure: The FFR and NHPR value at which the patient experiences angina in an exercise state
timeFrame: Intra-procedural
Secondary outcomes:
measure: The FFR difference between the rest and exercise states
timeFrame: Intra-procedural
measure: The NHPR difference between the rest and exercise states
timeFrame: Intra-procedural
measure: Angina severity score at the angina threshold
timeFrame: Intra-procedural
measure: Angina similarity score at the angina threshold
timeFrame: Intra-procedural
measure: Angina symptom type at the angina threshold
timeFrame: Intra-procedural
Other outcomes:
Locations:
city: Basildon
country: United Kingdom
facility: Mid and South Essex NHS Foundation Trust
city: Bournemouth
country: United Kingdom
facility: Royal Bournemouth and Christchurch Hospitals NHS Foundation Trust
city: London
country: United Kingdom
facility: Imperial College NHS Trust
city: London
country: United Kingdom
facility: Royal Free Hospital NHS Foundation Trust
city: London
country: United Kingdom
facility: St George's University Hospitals NHS Foundation Trust
city: Portsmouth
country: United Kingdom
facility: Portsmouth Hospitals NHS Trust
Study officials:
affiliation: Imperial College London
name: Rasha Al-Lamee, PhD MRCP
role: PRINCIPAL_INVESTIGATOR
References: