Multivessel Balloon Occlusion to Investigate Obstructive Coronary Artery Disease and aNgina

Status: Recruiting
Location: See all (9) locations...
Intervention Type: Diagnostic test, Procedure
Study Type: Interventional
Study Phase: Not Applicable
SUMMARY

ORBITA-MOON is a double-blinded, placebo-controlled experimental study that aims to understand how the different coronary artery stenoses contribute to overall clinical angina in patients with multi-vessel coronary artery disease. This study will investigate the symptoms conferred by each stenosis, induced by experimental ischaemia, for 60 patients with multi-vessel coronary artery disease.

Eligibility
Participation Requirements
Sex: All
Minimum Age: 18
Healthy Volunteers: f
View:

• Eligibility for PCI due to angina

• Anatomical evidence of significant multi-vessel coronary stenosis defined by either:

∙ ≥70% stenosis in two or more coronary arteries of ≥2.5mm visual diameter stenosis, on invasive coronary angiography (ICA)

‣ Severe stenosis in ≥2 coronary arteries of ≥ 2.5mm visual diameter stenosis, on CTCA

• Physiological evidence of ischaemia with a positive test corresponding to the coronary arteries to be stented, on at least one of the following:

‣ dobutamine stress echocardiogram

⁃ cardiac MRI

⁃ myocardial perfusion study

⁃ invasive metrics of coronary physiology

Locations
Other Locations
United Kingdom
Essex Cardiothoracic Centre
RECRUITING
Basildon
Royal Bournemouth Hospital
RECRUITING
Bournemouth
Royal Sussex County Hospital
RECRUITING
Brighton
Imperial College NHS Trust
RECRUITING
London
Royal Free London NHS Foundation Trust
RECRUITING
London
St Georges University Hospital
RECRUITING
London
Nottingham City Hospital
RECRUITING
Nottingham
Portsmouth Hospitals University NHS Trust
NOT_YET_RECRUITING
Portsmouth
University Hospital Southampton
RECRUITING
Southampton
Contact Information
Primary
Shayna Chotai, MBBS MRCP
s.chotai@imperial.ac.uk
02075945735
Backup
Rasha Al-Lamee, PhD MRCP
r.al-lamee13@imperial.ac.uk
02075945735
Time Frame
Start Date: 2024-06-13
Estimated Completion Date: 2027-04
Participants
Target number of participants: 60
Treatments
Experimental: Patients with stable angina
Patients who:~1. Are symptomatic with angina~2. Have anatomically severe multi-vessel coronary artery disease~3. Have physiological evidence of myocardial ischaemia
Sponsors
Collaborators: Mid and South Essex NHS Foundation Trust, Royal Free Hospital NHS Foundation Trust, Imperial College Healthcare NHS Trust, Royal Bournemouth and Christchurch Hospitals NHS Foundation Trust, St George's Healthcare NHS Trust
Leads: Imperial College London

This content was sourced from clinicaltrials.gov