Multivessel Balloon Occlusion to Investigate Obstructive Coronary Artery Disease and aNgina

Stable Angina Clinical Trial

— ORBITA-MOON  

Official title:

Multivessel Balloon Occlusion to Investigate Obstructive Coronary Artery Disease and aNgina

Clinical Trial Details — Status: Not yet recruiting

Administrative data

• NCT number: NCT06400290
• Other study ID #: 21HH7372
• Secondary ID: NIHR302493
• Status: Not yet recruiting
• Phase: N/A
• Start date: May 2024
• Est. completion date: April 2027

Study information

• Verified date: May 2024
• Source: Imperial College London
• Contact: Shayna Chotai, MBBS MRCP
• Phone: 02075945735
• Email: s.chotai[@]imperial.ac.uk
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial Summary

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.

Recruitment information / eligibility

• Status: Not yet recruiting
• Enrollment: 60
• Est. completion date: April 2027
• Est. primary completion date: January 2027
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

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

Related Conditions & MeSH terms

• Angina Pectoris
• Angina, Stable
• Coronary Artery Disease
• Coronary Disease
• Multivessel Coronary Artery Disease
• Myocardial Ischemia
• Stable Angina

Intervention

Procedure:
• Percutaneous coronary intervention (PCI)
Coronary artery stenting for stable angina

Diagnostic Test:
• Symptom assessment during experimentally induced ischaemia
Transient experimental balloon occlusion across coronary stenosis to determine the symptoms conferred by ischaemia at this stenosis.

Locations

Country	Name	City	State
United Kingdom	Essex Cardiothoracic Centre	Basildon
United Kingdom	Royal Bournemouth Hospital	Bournemouth
United Kingdom	Imperial College NHS Trust	London
United Kingdom	Royal Free London NHS Foundation Trust	London
United Kingdom	St Georges University Hospital	London
United Kingdom	Portsmouth Hospitals University NHS Trust	Portsmouth

Sponsors (6)

Lead Sponsor	Collaborator
Imperial College London	Imperial College Healthcare NHS Trust, Mid and South Essex NHS Foundation Trust, Royal Bournemouth and Christchurch Hospitals NHS Foundation Trust, Royal Free Hospital NHS Foundation Trust, St George's Healthcare NHS Trust

Country where clinical trial is conducted

United Kingdom, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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)	Intra-procedural
Secondary	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)	Intra-procedural
Secondary	Angina symptom type during induced ischaemia at the coronary stenosis	The patient will list all symptoms experienced during the experimental balloon inflation procedure.	Intra-procedural
Secondary	Change in angina symptom score	Fractional Change in Angina Frequency (0-1) (Lower Score = Better Outcome)	57 days
Secondary	Angina severity as assessed by Canadian Cardiovascular Society Class	Canadian Cardiovascular Society Class (0-IV) (Lower Score = Better Outcome)	57 days
Secondary	Angina severity as assessed by MRC dyspnoea scale	MRC dyspnoea score (1-5) (Lower Score = Better Outcome)	57 days
Secondary	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)	57 days
Secondary	Quality of Life assessed with the EQ-5D-5L questionnaire	EQ-5D-5L Questionnaire (-0.59 to 1), (Higher Score = Better Outcome)	57 days
Secondary	Psychological impact of angina as assessed by the PHQ-9 questionnaire	PHQ-9 Questionnaire (0-27), (Lower Score = Better Outcome)	57 days
Secondary	Psychological impact of angina as assessed by the Beck Depression Inventory	Beck Depression Inventory (0-63), (Lower Score = Better Outcome)	57 days
Secondary	Psychological impact of angina as assessed by the Coping Strategies Questionnaire	Coping Strategies Questionnaire (13-52), (Higher Score = Better Outcome)	57 days
Secondary	Psychological impact of angina as assessed by the Pain Catastrophizing Scale	Pain Catastrophizing Scale (0-52), (Lower Score = Better Outcome)	57 days
Secondary	Psychological impact of angina as assessed by the Profile of mood states questionnaire	Profile of mood states Questionnaire (0-44), (Lower Score = Better Outcome)	57 days
Secondary	Psychological impact of angina as assessed by the SCL-90 Questionnaire	SCL-90 Questionnaire (0-360), (Lower Score = Better Outcome)	57 days
Secondary	Need for anti-anginal medication introduction and uptitration	Has the patient required anti-anginal introduction and/or uptitration. (Score 0-1), (0 = no, 1 = yes)	57 days
Secondary	Angina type as assessed by the Rose Chest Pain Questionnaire	Rose Chest Pain Questionnaire (Score positive or negative), (Positive = pain suggestive of coronary heart disease, negative = pain not suggestive of coronary artery disease)	57 days
Secondary	Angina type as assessed by the McGill Pain Questionnaire	McGill Pain Questionnaire (Score 0-78), (Lower Score = Better Outcome)	57 days