Finding the Invasive Haemodynamic Threshold for Symptom Relief in Stable Angina

Stable Angina Clinical Trial

— ORBITA-FIRE  

Official title:

Finding the Invasive Haemodynamic Threshold for Symptom Relief in Stable Angina

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT05459051
• Other study ID #: P91528
• Secondary ID: 22HH7546
• Status: Recruiting
• Start date: September 1, 2022
• Est. completion date: April 8, 2025

Study information

• Verified date: March 2024
• Source: Imperial College London
• Contact: Fiyyaz Ahmed-Jushuf, MBBS MRCP
• Phone: 020 7594 5735
• Email: fiyyaz.ahmed-jushuf09[@]imperial.ac.uk
• Is FDA regulated: No
• Study type: Observational

Clinical Trial 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.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 58
• Est. completion date: April 8, 2025
• Est. primary completion date: April 8, 2025
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

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

Related Conditions & MeSH terms

• Angina Pectoris
• Angina, Stable
• Stable Angina

Intervention

Diagnostic Test:
• Rest-angina physiological assessment
The degree of stenosis required to cause angina at rest will be measured under double-blinded placebo controlled conditions using sequential intracoronary balloon inflations. This will then be correlated with various physiological indices, including FFR and NHPR.
• Exercise-angina physiological assessment
The degree of stenosis required to cause angina during exercise will be measured under double-blinded placebo controlled conditions using sequential intracoronary balloon inflations. This will then be correlated with various physiological indices, including FFR and NHPR.

Locations

Country	Name	City	State
United Kingdom	Mid and South Essex NHS Foundation Trust	Basildon
United Kingdom	Royal Bournemouth and Christchurch Hospitals NHS Foundation Trust	Bournemouth
United Kingdom	Imperial College NHS Trust	London
United Kingdom	Royal Free Hospital NHS Foundation Trust	London
United Kingdom	St George's University Hospitals NHS Foundation Trust	London
United Kingdom	Portsmouth Hospitals NHS Trust	Portsmouth

Sponsors (6)

Lead Sponsor	Collaborator
Imperial College London	Mid and South Essex NHS Foundation Trust, Portsmouth Hospitals NHS Trust, Royal Bournemouth and Christchurch Hospitals NHS Foundation Trust, Royal Free Hospital NHS Foundation Trust, St George's University Hospitals NHS Foundation Trust

Country where clinical trial is conducted

United Kingdom, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	The FFR and NHPR value at which the patient experiences angina in a rest state	Values 0.00-1.00 (Lower = More significant disease)	Intra-procedural
Primary	The FFR and NHPR value at which the patient experiences angina in an exercise state	Values 0.00-1.00 (Lower = More significant disease)	Intra-procedural
Secondary	The FFR difference between the rest and exercise states	Values 0.00-1.00 (Lower = More significant disease)	Intra-procedural
Secondary	The NHPR difference between the rest and exercise states	Values 0.00-1.00 (Lower = More significant disease)	Intra-procedural
Secondary	Angina severity score at the angina threshold	The patient scores the severity of the angina experienced during the procedure between 0-10 (Higher = More severe)	Intra-procedural
Secondary	Angina similarity score at the angina threshold	The patient scores the similarity of the angina experienced during the procedure against the angina experienced before the procedure between 0-10 (Higher = Most similar)	Intra-procedural
Secondary	Angina symptom type at the angina threshold	The patient will list all symptoms experienced at the angina threshold	Intra-procedural