Multivessel Balloon Occlusion to Investigate Obstructive Coronary Artery Disease and aNgina

Imperial College London60 enrolled

Overview

ORBITA-MOON is a double-blinded, placebo-controlled experimental study that aims to understand how the different coronary artery stenoses contribute to overall clinical angina in patients with multi-vessel coronary artery disease. This study will investigate the symptoms conferred by each stenosis, induced by experimental ischaemia, for 60 patients with multi-vessel coronary artery disease.

Study Type

INTERVENTIONAL

Allocation

Purpose

DIAGNOSTIC

Masking

NONE

Enrollment

Conditions

Stable Angina Multivessel Coronary Artery Disease

Interventions

Percutaneous coronary intervention (PCI)PROCEDURE

Coronary artery stenting for stable angina

Symptom assessment during experimentally induced ischaemiaDIAGNOSTIC_TEST

Transient experimental balloon occlusion across coronary stenosis to determine the symptoms conferred by ischaemia at this stenosis.

Eligibility

Sex: ALLMin age: 18 Years

Medical Language ↔ Plain English

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

Locations (9)

Essex Cardiothoracic Centre

Basildon, United Kingdom

RECRUITING

Royal Bournemouth Hospital

Bournemouth, United Kingdom

RECRUITING

Royal Sussex County Hospital

Outcomes

Primary Outcomes

Placebo-controlled similarity score during induced ischaemia at the coronary stenosis

The patient scores the similarity of the angina experienced during the experimental balloon inflation procedure against the angina experienced before the procedure between 0-10 (Higher Score = Most similar)

Time frame: Intra-procedural

Secondary Outcomes

Placebo-controlled intensity score during induced ischaemia at the coronary stenosis

The patient scores the severity of the angina experienced during the experimental balloon inflation procedure between 0-10 (Higher Score = More severe)

Time frame: Intra-procedural

Angina symptom type during induced ischaemia at the coronary stenosis

The patient will list all symptoms experienced during the experimental balloon inflation procedure.

Time frame: Intra-procedural

Change in angina symptom score

Fractional Change in Angina Frequency (0-1) (Lower Score = Better Outcome)

Time frame: 57 days

Angina severity as assessed by Canadian Cardiovascular Society Class

Canadian Cardiovascular Society Class (0-IV) (Lower Score = Better Outcome)

Time frame: 57 days

Angina severity as assessed by MRC dyspnoea scale

MRC dyspnoea score (1-5) (Lower Score = Better Outcome)

Time frame: 57 days

Physical limitation, angina stability, quality of life, angina frequency, freedom from angina as assessed with the Seattle Angina Questionnaire

Seattle Angina Questionnaire (0-100), (Higher Score = Better Outcome)

Central Contacts

Shayna Chotai, MBBS MRCP

CONTACT

02075945735 s.chotai@imperial.ac.uk

Rasha Al-Lamee, PhD MRCP

CONTACT

02075945735 r.al-lamee13@imperial.ac.uk

Data from ClinicalTrials.gov

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