Finding the Invasive Haemodynamic Threshold for Symptom Relief in Stable Angina

NCT05459051 | Recruiting DMC

• 2 other identifiers: P9152822HH7546
• Study Type: observational
• Target: 58
• Locations: 1 country
• Sites: 6

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.

Conditions

Stable Angina

Keywords

Symptoms; Angina; Physiology; Placebo

Outcome Measures

Primary Outcomes (2)

• 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

• 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 Outcomes (5)

• The FFR difference between the rest and exercise states

  Intra-procedural

• The NHPR difference between the rest and exercise states

  Intra-procedural

• Angina severity score at the angina threshold

  Intra-procedural

• Angina similarity score at the angina threshold

  Intra-procedural

• Angina symptom type at the angina threshold

  Intra-procedural

Study Arms (1)

Patients with stable angina

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

Diagnostic Test: Rest-angina physiological assessment; Diagnostic Test: Exercise-angina physiological assessment

Interventions

Rest-angina physiological assessment DIAGNOSTIC_TEST

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.

Patients with stable angina

Exercise-angina physiological assessment DIAGNOSTIC_TEST

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.

Patients with stable angina

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)
• Sampling Method: Probability Sample

Study Population

Patient with stable angina

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• Imperial College London: lead
• Royal Free Hospital NHS Foundation Trust: collaborator
• Mid and South Essex NHS Foundation Trust: collaborator
• St George's University Hospitals NHS Foundation Trust: collaborator
• Royal Bournemouth and Christchurch Hospitals NHS Foundation Trust: collaborator
• Portsmouth Hospitals NHS Trust: collaborator

Study Sites (6)

Mid and South Essex NHS Foundation Trust

Basildon, United Kingdom

RECRUITING

Royal Bournemouth and Christchurch Hospitals NHS Foundation Trust

Bournemouth, United Kingdom

RECRUITING

Imperial College NHS Trust

London, United Kingdom

RECRUITING

Royal Free Hospital NHS Foundation Trust

London, United Kingdom

RECRUITING

St George's University Hospitals NHS Foundation Trust

London, United Kingdom

RECRUITING

Portsmouth Hospitals NHS Trust

Portsmouth, United Kingdom

RECRUITING

MeSH Terms

Conditions

Angina, Stable; Angina Pectoris

Condition Hierarchy (Ancestors)

Myocardial Ischemia; Heart Diseases; Cardiovascular Diseases; Vascular Diseases; Chest Pain; Pain; Neurologic Manifestations; Signs and Symptoms; Pathological Conditions, Signs and Symptoms

Study Officials

• Rasha Al-Lamee, PhD MRCP

  Imperial College London

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Fiyyaz Ahmed-Jushuf, MBBS MRCP

CONTACT

020 7594 5735; fiyyaz.ahmed-jushuf09@imperial.ac.uk

Rasha Al-Lamee, PhD MRCP

CONTACT

020 7594 5735; r.al-lamee13@imperial.ac.uk

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: PROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: July 7, 2022
• First Posted: July 14, 2022
• Study Start: September 1, 2022
• Primary Completion: April 8, 2025
• Study Completion: April 8, 2025
• Last Updated: March 6, 2024

Record last verified: 2024-03

Data Sharing

• IPD Sharing: Will not share

Locations

GB (6)