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

March 4, 2024 updated by: Imperial College London
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.

Study Overview

Status

Recruiting

Conditions

Intervention / Treatment

Study Type

Observational

Enrollment (Estimated)

58

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

Study Contact Backup

Study Locations

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years and older (Adult, Older Adult)

Accepts Healthy Volunteers

No

Sampling Method

Probability Sample

Study Population

Patient with stable angina

Description

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

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

Cohorts and Interventions

Group / Cohort
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 NHPR.
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 NHPR.

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
The FFR and NHPR value at which the patient experiences angina in a rest state
Time Frame: Intra-procedural
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
Time Frame: Intra-procedural
Values 0.00-1.00 (Lower = More significant disease)
Intra-procedural

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
The FFR difference between the rest and exercise states
Time Frame: Intra-procedural
Values 0.00-1.00 (Lower = More significant disease)
Intra-procedural
Angina severity score at the angina threshold
Time Frame: Intra-procedural
The patient scores the severity of the angina experienced during the procedure between 0-10 (Higher = More severe)
Intra-procedural
Angina similarity score at the angina threshold
Time Frame: 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)
Intra-procedural
Angina symptom type at the angina threshold
Time Frame: Intra-procedural
The patient will list all symptoms experienced at the angina threshold
Intra-procedural
The NHPR difference between the rest and exercise states
Time Frame: Intra-procedural
Values 0.00-1.00 (Lower = More significant disease)
Intra-procedural

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Imperial College London

Collaborators

Royal Free Hospital NHS Foundation Trust
Mid and South Essex NHS Foundation Trust
Royal Bournemouth and Christchurch Hospitals NHS Foundation Trust
Portsmouth Hospitals NHS Trust
St George's University Hospitals NHS Foundation Trust

Investigators

  • Principal Investigator: Rasha Al-Lamee, PhD MRCP, Imperial College London

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

September 1, 2022

Primary Completion (Estimated)

April 8, 2025

Study Completion (Estimated)

April 8, 2025

Study Registration Dates

First Submitted

July 7, 2022

First Submitted That Met QC Criteria

July 13, 2022

First Posted (Actual)

July 14, 2022

Study Record Updates

Last Update Posted (Estimated)

March 6, 2024

Last Update Submitted That Met QC Criteria

March 4, 2024

Last Verified

March 1, 2024

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • P91528
  • 22HH7546 (Other Identifier: Imperial College London)

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

NO

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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