Lesion-specific angina thresholds measured during invasive coronary testing
Study of Lesion-Specific Invasive Haemodynamic Angina Thresholds
This project tests whether different coronary narrowings cause angina at different levels of blood-flow reduction in people with stable angina who have two blockages suitable for PCI.
Quick facts
| Phase | Not applicable |
|---|---|
| Study type | Interventional |
| Enrollment | 60 (estimated) |
| Ages | 18 Years and up |
| Sex | All |
| Sponsor | Imperial College London Academic / other |
| Locations | 6 sites (Basildon and 5 other locations) |
| Trial ID | NCT07386418 on ClinicalTrials.gov |
What this trial studies
Sixty patients with stable angina and two severe coronary stenoses amenable to PCI will be recruited. During invasive coronary angiography, investigators will perform intracoronary balloon inflation at each lesion while the patient exercises supine on an ergometer to reproduce symptoms. Real-time physiological measurements including fractional flow reserve (FFR) and non-hyperemic pressure ratio (NHPR) will be recorded to define the angina threshold at each stenosis. The protocol compares lesion-specific haemodynamic changes to symptom onset to determine whether different stenoses provoke angina at different levels of flow reduction.
Who should consider this trial
Good fit: Adults with stable exertional angina, two severe epicardial stenoses (typically ≥70% or in a ≥2.5 mm vessel), evidence of ischemia on testing, and eligibility for PCI are the ideal candidates.
Not a fit: People with a single lesion, recent acute coronary syndrome, prior CABG, significant left main disease, chronic total occlusion, severe valve disease, LVEF ≤40%, or who are not eligible for PCI are unlikely to benefit or qualify.
Why it matters
Potential benefit: If successful, this could help doctors target PCI to the specific lesions that actually cause symptoms, personalizing treatment for people with multivessel disease.
How similar studies have performed: Related placebo-controlled work on PCI (for example ORBITA) showed important effects on symptom interpretation, but lesion-specific angina threshold measurement using intracoronary balloon inflation during exercise is a largely novel and untested approach.
Eligibility criteria
Show full inclusion / exclusion criteria
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
Where this trial is running
Basildon and 5 other locations
- 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)
Study contacts
- Study coordinator: Kayla Chiew, MBBS MRCP
- Email: kayla.chiew@imperial.ac.uk
- Phone: 020 7594 5735
How to participate
- Review the eligibility criteria above with your treating physician.
- Visit the official trial page on ClinicalTrials.gov for the most current contact information and recruitment status.
- Contact the listed study coordinator or principal investigator to request pre-screening. Pre-screening is free and never obligates you to enroll.