Health TrialsbyHealthPanel

Study of Lesion-Specific Invasive Haemodynamic Angina Thresholds

ConditionsAngina (Stable)Coronary Artery Disease(CAD)Ischaemic Heart Disease (IHD)
Trial statusRecruiting
Trial phaseNot applicable
Trial typeInterventional
Biological sexAll
Age18+
SponsorImperial College London

About this trial

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 criteria

This trial does not accept healthy volunteers

Qualifiers

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

≥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

Physiological test during invasive coronary angiography (ICA)

Disqualifiers

Age <18 years

Acute coronary syndrome within 3 months

Previous coronary artery bypass graft

Significant left main stem disease

Trial design

Design model

Single group

Treatments tested in this trial

  • Percutaneous coronary intervention (PCI)

    Procedure/Surgery

    Clinically indicated PCI for the management of stable angina

  • 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.

Treatment groups

60 Participants
are divided into 1 treatment group
Group A: Patients with stable coronary artery diseaseExperimental treatment 2 interventions

Trial outcomes

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.

Time frame
Intra-procedural

Secondary outcomes

1

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
2

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
3

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
4

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

Other outcomes

Sponsors and contacts

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Imperial College London

Lead sponsor

St George's University Hospitals NHS Foundation Trust

Collaborator

Royal Free Hospital NHS Foundation Trust

Collaborator

University Hospitals Dorset NHS Foundation Trust

Collaborator

Mid and South Essex NHS Foundation Trust

Collaborator

Imperial College Healthcare NHS Trust

Collaborator

Chelsea and Westminster NHS Foundation Trust

Collaborator

Guy's and St Thomas' NHS Foundation Trust

Collaborator

Liverpool Heart and Chest Hospital NHS Foundation Trust

Collaborator

Source ClinicalTrials.gov
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