Refractory Angina
Conditions
Brief summary
ORBITA-COSMIC is a randomised, double-blinded, placebo controlled trial of the coronary sinus reducer (CSR). The investigators will compare the effects of CSR versus placebo on myocardial perfusion on MRI, exercise time and symptoms in 50 participants with refractory angina and ischaemia.
Interventions
DEVICECoronary Sinus Reducer
Coronary Sinus Reducer implantation according to standard clinical protocols
PROCEDUREPlacebo Procedure
A placebo procedure involving venous sheath implantation in the right internal jugular vein without proceeding to CSR implantation
Sponsors
Medical Research Council
Imperial College Healthcare Nissen Fund
Imperial College London
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
QUADRUPLE (Subject, Caregiver, Investigator, Outcomes Assessor)
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No
Inclusion criteria
* Stable coronary artery disease (CAD) not eligible for percutaneous coronary intervention (PCI) or coronary artery bypass graft surgery (CABG) * Evidence of ischaemia on stress perfusion CMR * Angina - Canadian Cardiovascular Society Class II-VI on maximal medical therapy
Exclusion criteria
* Age\<18 years * Pregnancy * Inability to consent * Recent acute coronary syndrome (3 months) * Recent revascularisation (6 months) * Permanent pacemaker or defibrillator leads in the right heart * Severe left ventricular impairment (\<25%) * Indication for cardiac resynchronisation therapy (CRT) * Right atrial pressure ≥15mmHg * Life expectancy \<1 year * Severe renal impairment (eGFR\<15) * Contraindication to CMR * Contraindication to adenosine * Ischaemia isolated to inferior wall * Ongoing participation in a separate interventional study
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Myocardial Blood Flow | 6 months | On cardiac MRI, with adenosine stress, millilitres/gram/minute |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Episodes of angina component of angina symptom score | 6 months | Daily episodes recorded on ORBITA-COSMIC smartphone application |
| Canadian Cardiovascular Society Class | 6 months | On a scale from 0-4 with higher scores indicating more severe angina |
| Myocardial perfusion reserve (MPR) in ischaemic segments, non ischaemic segments and global MPR | 6 months | On cardiac MRI |
| Rest myocardial blood flow (MBF) in ischaemic segments, non ischaemic segments and global rest MBF | 6 months | On cardiac MRI, millilitres/gram/minute |
| Stress myocardial blood flow (MBF) in ischaemic segments, non ischaemic segments and global stress MBF | 6 months | On cardiac MRI, millilitres/gram/minute |
| MPR in ischaemic segments with inferior and inferoseptal segments excluded | 6 months | On cardiac MRI |
| MBF in ischaemic segments with inferior and inferoseptal segments excluded | 6 months | On cardiac MRI, millilitres/gram/minute |
| Endocardial:epicardial ratio of stress MBF | 6 months | On cardiac MRI |
| Endocardial:epicardial ratio of rest MBF | 6 months | On cardiac MRI |
| Endocardial:epicardial ratio of MPR | 6 months | On cardiac MRI |
| Myocardial strain | 6 months | On cardiac MRI |
| Myocardial scar burden | 6 months | On cardiac MRI |
| Seattle Angina Questionnaire (SAQ) Angina Frequency | 6 months | On a scale from 0-100, with higher scores indicating better outcomes |
| Angina symptom score | 6 months | Derived from ORBITA-COSMIC smartphone application |
| SAQ Quality of Life | 6 months | On a scale from 0-100, with higher scores indicating better outcomes |
| SAQ Treatment Satisfaction | 6 months | On a scale from 0-100, with higher scores indicating better outcomes |
| SAQ Angina Stability | 6 months | On a scale from 0-100, with higher scores indicating better outcomes |
| Euro-Qol (EQ-5D-5L) descriptive system | 6 months | Index derived from 5 question domains, with higher scores indicating better quality of life |
| Euro-Qol (EQ-5D-5L) visual analogue scale | 6 months | Visual analogue scale from 0-100 with 100 indicating better quality of life |
| Angina related quality of life rated by the MacNew questionnaire | 6 months | On a scale from 1-7 with higher scores indicating better quality of life |
| Treadmill Exercise Time | 6 months | Modified Bruce Protocol |
| Absolute coronary flow on pressure/temperature wire assessment | 6 months | millilitres per minute |
| Absolute coronary resistance on pressure/temperature wire assessment | 6 months | mmHg/(L/min) |
| Microvascular resistance reserve on pressure/temperature wire assessment | 6 months | — |
| Coronary flow reserve (CFR) on pressure/temperature wire assessment | 6 months | — |
| Index of microcirculatory resistance on pressure/temperature wire assessment | 6 months | — |
| CFR assessed by a pressure and doppler sensor wire | 6 months | — |
| SAQ Angina Physical Limitation | 6 months | On a scale from 0-100, with higher scores indicating better outcomes |
Countries
United Kingdom
Contacts
Primary ContactRasha Al-Lamee, PhD MRCP
Backup ContactMichael Foley, MBBS MRCP
Outcome results
None listed