Study of Lesion-Specific Invasive Haemodynamic Angina Thresholds (ORBITA-SOLAR)

Imperial College London

Status: Not yet enrolling

Conditions: Ischaemic Heart Desease; Angina (Stable); Coronary Artery Disease(CAD)

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

Study type: Interventional

Funder types: Other

Identifiers

NCT07386418

199514

Details and patient eligibility

About

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.

Enrollment: 60 estimated patients

Sex: All

Ages: 18+ years old

Volunteers: No Healthy Volunteers

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

Trial design

Primary purpose: Diagnostic

Allocation: N/A

Interventional model: Single Group Assignment

Masking: None (Open label)

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60 participants in 1 patient group

Patients with stable coronary artery disease

Experimental group

Description:

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)

Treatment:

Procedure: Percutaneous coronary intervention (PCI)

Diagnostic Test: Measurement of the angina threshold