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

Multivessel Balloon Occlusion to Investigate Obstructive Coronary Artery Disease and aNgina

This study is testing how different blockages in the heart's arteries affect chest pain in people with multiple artery problems.

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: 9 sites (Basildon and 8 other locations)
• Trial ID: NCT06400290 on ClinicalTrials.gov

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.

Who should consider this trial

Good fit: Ideal candidates are patients eligible for PCI with significant multi-vessel coronary stenosis and evidence of ischaemia.

Not a fit: Patients with recent acute coronary syndrome or those who have had previous coronary artery bypass graft surgery may not benefit from this study.

Why it matters

Potential benefit: If successful, this study could lead to improved understanding and management of angina symptoms in patients with multi-vessel coronary artery disease.

How similar studies have performed: Other studies have shown promise in understanding coronary artery disease through similar methodologies, but this specific approach is relatively novel.

Eligibility criteria

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
  * 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 this trial is running

Basildon and 8 other locations

• 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)
• Nottingham City Hospital — Nottingham, United Kingdom (Recruiting)
• Portsmouth Hospitals University NHS Trust — Portsmouth, United Kingdom (Not_yet_recruiting)
• University Hospital Southampton — Southampton, United Kingdom (Recruiting)

Study contacts

• Principal investigator: Rasha Al-Lamee, PhD MRCP — Imperial College London
• Study coordinator: Shayna Chotai, MBBS MRCP

Conditions Stable Angina; Multivessel Coronary Artery Disease; Angina; Multi-vessel coronary artery disease; Symptoms; Placebo-controlled symptom assessment