Study of Lesion-Specific Invasive Haemodynamic Angina Thresholds

N/ANot Yet RecruitingNCT07386418

Imperial College London60 enrolled

Overview

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.

Study Type

INTERVENTIONAL

Allocation

Purpose

DIAGNOSTIC

Masking

NONE

Enrollment

Conditions

Angina (Stable)Ischaemic Heart Desease Coronary Artery Disease(CAD)

Interventions

Percutaneous coronary intervention (PCI)PROCEDURE

Clinically indicated PCI for the management of stable angina

Measurement of the angina thresholdDIAGNOSTIC_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.

Eligibility

Sex: ALLMin age: 18 Years

Medical Language ↔ Plain English

Inclusion Criteria: 1. Eligibility for PCI due to angina or angina-equivalent symptoms on exertion 2. 2 severe epicardial stenoses in a major coronary artery, defined as: 1. ≥70% stenosis in a coronary artery with ≥2.5mm diameter, on invasive coronary angiography (ICA) 2. Severe stenosis in a vessel with ≥2.5mm diameter, on CTCA 3. Evidence of ischaemia on an invasive or non-invasive test, including: 1. Physiological test during invasive coronary angiography (ICA) 2. Dobutamine stress echocardiography (DSE) 3. Stress perfusion cardiac magnetic resonance (CMR) 4. Myocardial perfusion scintigraphy (MPS) 5. Fractional flow reserve computed-tomography (FFR-CT) Exclusion Criteria: 1. Age \<18 years 2. Acute coronary syndrome within 3 months 3. Previous coronary artery bypass graft 4. Significant left main stem disease 5. Single lesion amenable to PCI 6. Chronic total occlusion of the target artery 7. Moderate to severe valve disease 8. LVEF ≤40%, contraindication to PCI or drug-eluting stents 9. PCI performed with drug-eluting balloons without stenting 10. Contraindication to antiplatelet therapy 11. Contraindication to adenosine 12. Physical inability to exercise with an ergometer 13. Femoral artery access 14. Pregnancy 15. Inability to consent

Locations (6)

Mid and South Essex NHS Foundation Trust

Basildon, United Kingdom

University Hospitals Dorset NHS Foundation Trust

Bournemouth, United Kingdom

Imperial College Healthcare NHS Trust

London, United Kingdom

Royal Free London NHS Foundation Trust

London, United Kingdom

St George's University Hospitals NHS Foundation Trust

London, United Kingdom

Portsmouth Hospitals University NHS Trust

Portsmouth, United Kingdom

Outcomes

Primary Outcomes

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.

Time frame: Intra-procedural

Secondary Outcomes

Correlation of the angina threshold with other invasive physiological assessments

Including coronary artery disease pattern (focal, diffuse or mixed), presence of microvascular disease (IMR and CFR), extent of collateral flow (CFI), and pre- and post-PCI ischaemia (FFR and RFR)

Time frame: Intra-procedural

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

Including proportion of myocardial mass subtended (%), coronary artery territory (LAD, LCx, RCA), and lesion location along a vessel (proximal, mid, distal)

Time frame: 14 days

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

Including lesion length (mm), minimum lumen diameter, (mm) percent diameter stenosis (%), and reference vessel diameter (mm)

Time frame: 14 days

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

Including lesion length (mm), pre-PCI minimum lumen area (mm2), post-PCI minimum stent area (mm2), reference vessel cross-sectional area (mm2), plaque characteristics (lipid, fibrotic, calcific)

Time frame: Intra-procedural

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

Including myocardial perfusion reserve (MPR), number of segments of infarcted myocardium, and percentage mural infarct depth (%)

Time frame: 14 days

Correlation of the angina threshold with baseline symptoms, quality of life and pain perception

Assessed with the ORBITA-app and validated questionnaires (SAQ, EQ5D5L)

Time frame: 14 days

Study of Lesion-Specific Invasive Haemodynamic Angina Thresholds

Overview

Conditions

Interventions

Eligibility

Locations (6)

Outcomes

Primary Outcomes

Secondary Outcomes

Central Contacts