Study of Lesion-Specific Invasive Haemodynamic Angina Thresholds

NCT07386418 | Recruiting

• 1 other identifier: 199514
• Study Type: interventional
• Target: 60
• Locations: 1 country
• Sites: 6

Brief 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); Ischaemic Heart Desease; Coronary Artery Disease(CAD)

Keywords

Angina; Coronary physiology; Coronary haemodynamics; Placebo-control; Symptoms

Outcome Measures

Primary Outcomes (1)

• Intra-individual difference in FFR and NHPR angina thresholds

  Difference in invasively measured physiological angina thresholds at the site of the 2 stents within each participant, stratified by vascular territory and lesion location along a vessel.

  Intra-procedural

Secondary Outcomes (6)

• Correlation of the angina threshold with other invasive physiological assessments

  Intra-procedural

• Correlation of the angina threshold with anatomical characteristics assessed with computed tomography coronary angiography (CTCA)

  14 days

• Correlation of the angina threshold with anatomical characteristics assessed with quantitative coronary angiography (QCA)

  14 days

• Correlation of the angina threshold with anatomical characteristics assessed with intravascular imaging

  Intra-procedural

• Correlation of the angina threshold with features on a stress perfusion cardiac magnetic resonance imaging (CMR) scan

  14 days

Study Arms (1)

Patients with stable coronary artery disease

EXPERIMENTAL

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)

Procedure: Percutaneous coronary intervention (PCI); Diagnostic Test: Measurement of the angina threshold

Interventions

Measurement of the angina threshold DIAGNOSTIC_TEST

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.

Patients with stable coronary artery disease

Percutaneous coronary intervention (PCI) PROCEDURE

Clinically indicated PCI for the management of stable angina

Patients with stable coronary artery disease

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

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

You may not qualify if:

• Age \<18 years
• Acute coronary syndrome within 3 months
• Previous coronary artery bypass graft
• Significant left main stem disease
• Single lesion amenable to PCI
• Chronic total occlusion of the target artery
• Moderate to severe valve disease
• LVEF ≤40%, contraindication to PCI or drug-eluting stents
• PCI performed with drug-eluting balloons without stenting
• Contraindication to antiplatelet therapy
• Contraindication to adenosine
• Physical inability to exercise with an ergometer
• Femoral artery access
• Pregnancy
• Inability to consent

Sponsors & Collaborators

• Royal Free Hospital NHS Foundation Trust: collaborator
• University Hospitals Dorset NHS Foundation Trust: collaborator
• Mid and South Essex NHS Foundation Trust: collaborator
• Portsmouth Hospitals NHS Trust: collaborator
• Imperial College Healthcare NHS Trust: collaborator
• Imperial College London: lead
• St George's University Hospitals NHS Foundation Trust: collaborator

Study Sites (6)

Mid and South Essex NHS Foundation Trust

Basildon, United Kingdom

NOT YET RECRUITING

University Hospitals Dorset NHS Foundation Trust

Bournemouth, United Kingdom

NOT YET RECRUITING

Imperial College Healthcare NHS Trust

London, United Kingdom

RECRUITING

Royal Free London NHS Foundation Trust

London, United Kingdom

NOT YET RECRUITING

St George's University Hospitals NHS Foundation Trust

London, United Kingdom

NOT YET RECRUITING

Portsmouth Hospitals University NHS Trust

Portsmouth, United Kingdom

NOT YET RECRUITING

MeSH Terms

Conditions

Angina, Stable; Coronary Artery Disease; Angina Pectoris

Interventions

Percutaneous Coronary Intervention

Condition Hierarchy (Ancestors)

Myocardial Ischemia; Heart Diseases; Cardiovascular Diseases; Vascular Diseases; Chest Pain; Pain; Neurologic Manifestations; Signs and Symptoms; Pathological Conditions, Signs and Symptoms; Coronary Disease; Arteriosclerosis; Arterial Occlusive Diseases

Intervention Hierarchy (Ancestors)

Endovascular Procedures; Vascular Surgical Procedures; Cardiovascular Surgical Procedures; Surgical Procedures, Operative; Minimally Invasive Surgical Procedures

Central Study Contacts

Kayla Chiew, MBBS MRCP

CONTACT

020 7594 5735; kayla.chiew@imperial.ac.uk

Rasha Al-Lamee, MBBS PhD MRCP

CONTACT

020 7594 5735; r.al-lamee13@imperial.ac.uk

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NA
• Masking: NONE
• Masking Details: During cardiac catheterisation, there will be one blinded component to verify the reproducibility of symptoms against placebo. One true and one placebo balloon inflation will be performed, in a randomised order. Both the participant and outcome assessor will be blinded to the order of true or placebo balloon inflation. The participant will be asked to report any symptoms they have.
• Purpose: DIAGNOSTIC
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Model Details: All participants will partake in the same research protocol.

Study Record Dates

• First Submitted: January 19, 2026
• First Posted: February 4, 2026
• Study Start: February 10, 2026
• Primary Completion (Estimated): December 1, 2028
• Study Completion (Estimated): December 1, 2028
• Last Updated: February 18, 2026

Record last verified: 2026-02

Data Sharing

• IPD Sharing: Will not share

Locations

GB (6)