Finding the Invasive Haemodynamic Threshold for Symptom Relief in Stable Angina

Status: Recruiting
Location: See all (6) locations...
Intervention Type: Diagnostic test
Study Type: Observational
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
Participation Requirements
Sex: All
Minimum Age: 18
Healthy Volunteers: f
View:

• 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

Locations
Other Locations
United Kingdom
Mid and South Essex NHS Foundation Trust
RECRUITING
Basildon
Royal Bournemouth and Christchurch Hospitals NHS Foundation Trust
RECRUITING
Bournemouth
Imperial College NHS Trust
RECRUITING
London
Royal Free Hospital NHS Foundation Trust
RECRUITING
London
St George's University Hospitals NHS Foundation Trust
RECRUITING
London
Portsmouth Hospitals NHS Trust
RECRUITING
Portsmouth
Contact Information
Primary
Fiyyaz Ahmed-Jushuf, MBBS MRCP
fiyyaz.ahmed-jushuf09@imperial.ac.uk
020 7594 5735
Backup
Rasha Al-Lamee, PhD MRCP
r.al-lamee13@imperial.ac.uk
020 7594 5735
Time Frame
Start Date: 2022-09-01
Estimated Completion Date: 2025-04-08
Participants
Target number of participants: 58
Treatments
Patients with stable angina
* Symptomatic~* Anatomically severe single-vessel coronary artery disease~* Physiological evidence of myocardial ischaemia
Related Therapeutic Areas
Sponsors
Collaborators: St George's University Hospitals NHS Foundation Trust, Mid and South Essex NHS Foundation Trust, Royal Free Hospital NHS Foundation Trust, Royal Bournemouth and Christchurch Hospitals NHS Foundation Trust, Portsmouth Hospitals NHS Trust
Leads: Imperial College London

This content was sourced from clinicaltrials.gov