Investigating the effects of balloon occlusion on angina in patients with multi-vessel coronary artery disease

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

This study aims to explore how different coronary artery blockages contribute to angina symptoms in patients with multi-vessel coronary artery disease. It is a double-blinded, placebo-controlled trial involving 60 participants who will undergo percutaneous coronary intervention (PCI) and symptom assessments during induced ischaemia. The study will evaluate the impact of each blockage on overall clinical angina, providing insights into the relationship between stenosis and symptoms. Participants will be monitored closely to assess their responses to the interventions.

Why it matters

Who can join: the full rules

Inclusion Criteria:

* Eligibility for PCI due to angina
* Anatomical evidence of significant multi-vessel coronary stenosis defined by either:

  1. ≥70% stenosis in two or more coronary arteries of ≥2.5mm visual diameter stenosis, on invasive coronary angiography (ICA)
  2. Severe stenosis in ≥2 coronary arteries of ≥ 2.5mm visual diameter stenosis, on CTCA
* Physiological evidence of ischaemia with a positive test corresponding to the coronary arteries to be stented, on at least one of the following:

  * dobutamine stress echocardiogram
  * cardiac MRI
  * myocardial perfusion study
  * CT-FFR
  * invasive metrics of coronary physiology

Exclusion Criteria:

* Recent acute coronary syndrome
* Previous coronary artery by-pass graft surgery (CABG)
* Significant left main stem disease
* Chronic total occlusion in the target artery(s)
* Moderate to severe valvular disease
* Moderate to severe left ventricular impairment
* Contraindication to PCI or a drug-eluting stents
* Contraindication to antiplatelet therapy
* Contraindication to adenosine
* Pregnant
* Inability to consent

Where it's running

• Essex Cardiothoracic Centre
  Basildon, United Kingdom Recruiting
• Royal Bournemouth Hospital
  Bournemouth, United Kingdom Recruiting
• Royal Sussex County Hospital
  Brighton, United Kingdom Recruiting
• Imperial College NHS Trust
  London, United Kingdom Recruiting
• Royal Free London NHS Foundation Trust
  London, United Kingdom Recruiting
• St Georges University Hospital
  London, United Kingdom Recruiting

Study contacts

• Principal investigator: Rasha Al-Lamee, PhD MRCP — Imperial College London
• Study coordinator: Shayna Chotai, MBBS MRCP
• Email: s.chotai@imperial.ac.uk
• Phone: 02075945735

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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.