Lesion-specific angina thresholds measured during invasive coronary testing

Is this trial a fit for you?

A plain-English reading of the study's rules. Only the study team can confirm whether you qualify.

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.

Why it matters

Who can join: the full rules

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 it's running

• Mid and South Essex NHS Foundation Trust
  Basildon, United Kingdom Recruiting
• University Hospitals Dorset NHS Foundation Trust
  Bournemouth, United Kingdom Recruiting
• Chelsea and Westminster Hospital NHS Foundation Trust
  London, United Kingdom Recruiting
• Imperial College Healthcare NHS Trust
  London, United Kingdom Recruiting
• Royal Free London NHS Foundation Trust
  London, United Kingdom Recruiting
• St George's University Hospitals NHS Foundation Trust
  London, United Kingdom Recruiting

Study contacts

• Study coordinator: Kayla Chiew, MBBS MRCP
• Email: kayla.chiew@imperial.ac.uk
• Phone: 020 7594 5735

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How to take part

1. Review the eligibility criteria above with your treating physician.
2. Check the official listing on ClinicalTrials.gov for the latest contact details and recruitment status.
3. Contact the study coordinator or principal investigator to ask for pre-screening. Pre-screening is free and never obligates you to enroll.