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Study of Lesion-Specific Invasive Haemodynamic Angina Thresholds

Status: Recruiting
Location: See all (6) locations...
Intervention Type: Procedure, Diagnostic test
Study Type: Interventional
Study Phase: Not Applicable
SUMMARY

ORBITA-SOLAR is an invasive physiological cardiac catheterisation study that aims to determine whether different coronary stenoses have different angina thresholds. The angina threshold is defined as the amount of coronary flow reduction required to reproduce symptoms. Sixty patients with symptoms of stable angina and 2 coronary artery stenoses amenable to percutaneous coronary intervention (PCI) will be recruited. This study will use intra-coronary balloon inflation during supine exercise on an ergometer to measure the fractional flow reserve (FFR) and non-hyperemic pressure ratio (NHPR) that relates to angina onset, in real time, at the location of each stenosis.

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

• Eligibility for PCI due to angina or angina-equivalent symptoms on exertion

• 2 severe epicardial stenoses in a major coronary artery, defined as:

‣ ≥70% stenosis in a coronary artery with ≥2.5mm diameter, on invasive coronary angiography (ICA)

⁃ Severe stenosis in a vessel with ≥2.5mm diameter, on CTCA

• Evidence of ischaemia on an invasive or non-invasive test, including:

‣ Physiological test during invasive coronary angiography (ICA)

⁃ Dobutamine stress echocardiography (DSE)

⁃ Stress perfusion cardiac magnetic resonance (CMR)

⁃ Myocardial perfusion scintigraphy (MPS)

⁃ Fractional flow reserve computed-tomography (FFR-CT)

Locations
Other Locations
United Kingdom
Mid and South Essex NHS Foundation Trust
NOT_YET_RECRUITING
Basildon
University Hospitals Dorset NHS Foundation Trust
NOT_YET_RECRUITING
Bournemouth
Imperial College Healthcare NHS Trust
RECRUITING
London
Royal Free London NHS Foundation Trust
NOT_YET_RECRUITING
London
St George's University Hospitals NHS Foundation Trust
NOT_YET_RECRUITING
London
Portsmouth Hospitals University NHS Trust
NOT_YET_RECRUITING
Portsmouth
Contact Information
Primary
Kayla Chiew, MBBS MRCP
kayla.chiew@imperial.ac.uk
020 7594 5735
Backup
Rasha Al-Lamee, MBBS PhD MRCP
r.al-lamee13@imperial.ac.uk
020 7594 5735
Time Frame
Start Date: 2026-02-10
Estimated Completion Date: 2028-12
Participants
Target number of participants: 60
Treatments
Experimental: Patients with stable coronary artery disease
1. Symptoms of stable angina~2. Evidence of ischaemia on an invasive or non-invasive test~3. Two coronary stenoses amenable to percutaneous coronary intervention (PCI)
Sponsors
Collaborators: St George's University Hospitals NHS Foundation Trust, Mid and South Essex NHS Foundation Trust, Royal Free Hospital NHS Foundation Trust, Imperial College Healthcare NHS Trust, Portsmouth Hospitals NHS Trust, University Hospitals Dorset NHS Foundation Trust
Leads: Imperial College London

This content was sourced from clinicaltrials.gov