ORBITA-FIRE: Finding the Invasive Haemodynamic Threshold for Symptom Relief in Stable Angina

Sponsor

Imperial College London (Other)

Overall Status

Recruiting

CT.gov ID

NCT05459051

Collaborator

Royal Free Hospital NHS Foundation Trust (Other), Mid and South Essex NHS Foundation Trust (Other), St George's University Hospitals NHS Foundation Trust (Other), Royal Bournemouth and Christchurch Hospitals NHS Foundation Trust (Other)

Enrollment

Locations

32.2

Anticipated Duration (Months)

11.6

Patients Per Site

0.4

Patients Per Site Per Month

Study Details

Study Description

Brief Summary

ORBITA-FIRE is a randomised, double-blinded, placebo controlled experimental study that will identify the fractional flow reserve (FFR) and instantaneous wave-free ratio (iFR) thresholds that correlate with symptoms of angina for 58 patients measured invasively under experimental conditions.

Condition or Disease	Intervention/Treatment	Phase
Stable Angina	Diagnostic Test: Rest-angina physiological assessment Diagnostic Test: Exercise-angina physiological assessment

Study Design

Study Type:

Observational

Anticipated Enrollment :

58 participants

Observational Model:

Cohort

Time Perspective:

Prospective

Official Title:

Finding the Invasive Haemodynamic Threshold for Symptom Relief in Stable Angina

Anticipated Study Start Date :

Aug 1, 2022

Anticipated Primary Completion Date :

Apr 8, 2025

Anticipated Study Completion Date :

Apr 8, 2025

Arms and Interventions

Arm	Intervention/Treatment
Patients with stable angina Symptomatic Anatomically severe single-vessel coronary artery disease Physiological evidence of myocardial ischaemia	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 iFR. Diagnostic Test: 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 iFR.

Arm

Intervention/Treatment

Patients with stable angina

Symptomatic Anatomically severe single-vessel coronary artery disease Physiological evidence of myocardial ischaemia

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 iFR.

Diagnostic Test: 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 iFR.

Outcome Measures

Primary Outcome Measures

The FFR and iFR value at which the patient experiences angina at rest [Intra-procedural]
Values 0.00-1.00 (Lower = More significant disease)
The FFR and iFR value at which the patient experiences angina on exercise [Intra-procedural]
Values 0.00-1.00 (Lower = More significant disease)

Secondary Outcome Measures

Angina severity score at the angina threshold [Intra-procedural]
The patient scores the severity of the angina experienced during the procedure between 0-10 (Higher = More severe)
Angina similarity score at the angina threshold [Intra-procedural]
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)
Angina symptom type at the angina threshold [Intra-procedural]
The patient will list all symptoms experienced at the angina threshold

Eligibility Criteria

Criteria

Ages Eligible for Study:

18 Years and Older

Sexes Eligible for Study:

All

Accepts Healthy Volunteers:

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

Contacts and Locations

Locations

	Site	City	Country
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
5	St George's University Hospitals NHS Foundation Trust	London	United Kingdom