Study of Lesion-Specific Invasive Haemodynamic Angina Thresholds

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.

Conditions

• Angina (Stable)
• Coronary Artery Disease(CAD)
• Ischaemic Heart Disease (IHD)

Interventions

PROCEDURE

Percutaneous coronary intervention (PCI)

Clinically indicated PCI for the management of stable angina

DIAGNOSTIC_TEST

Measurement of the angina threshold

Following stenting, the order in which to perform the angina threshold assessment at the location of each stent will be randomised. A non-compliant balloon with gradually be inflated over a pressure wire within the deployed stent to re-introduce stenosis. Simultaneously, the participant will exercise on a supine ergometer. At the point when angina is reproduced, the patient will rest and further balloon inflation will stop. Physiological measurements using the pressure wire will be taken with the inflated balloon in situ. This will represent the invasive physiological angina threshold. The balloon will then be deflated and removed. These steps will be repeated at the location of the second stent.

Sponsors & Collaborators

• St George's University Hospitals NHS Foundation Trust

  collaborator OTHER

• Royal Free Hospital NHS Foundation Trust

  collaborator OTHER

• University Hospitals Dorset NHS Foundation Trust

  collaborator OTHER_GOV

• Mid and South Essex NHS Foundation Trust

  collaborator OTHER

• Imperial College Healthcare NHS Trust

  collaborator OTHER

• Chelsea and Westminster NHS Foundation Trust

  collaborator OTHER

• Guy's and St Thomas' NHS Foundation Trust

  collaborator OTHER

• Liverpool Heart and Chest Hospital NHS Foundation Trust

  collaborator OTHER

• Imperial College London

  lead OTHER

Study Design

Allocation

NA

Purpose

DIAGNOSTIC

Masking

NONE

Model

SINGLE_GROUP

Eligibility

Min Age

18 Years

Sex

ALL

Healthy Volunteers

No

Timeline & Regulatory

Start

2026-02-10

Primary Completion

2028-12-31

Completion

2028-12-31

Countries

• United Kingdom

Study Locations