Coronary Sinus Reducer Objective Impact on Symptoms, MRI Ischaemia and Microvascular Resistance
- Conditions
- Refractory Angina
- Interventions
- Device: Coronary Sinus ReducerProcedure: Placebo Procedure
- Registration Number
- NCT04892537
- Lead Sponsor
- Imperial College London
- 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.
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- RECRUITING
- Sex
- All
- Target Recruitment
- 50
- 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
- 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
Study & Design
- Study Type
- INTERVENTIONAL
- Study Design
- PARALLEL
- Arm && Interventions
Group Intervention Description CSR Coronary Sinus Reducer Coronary Sinus Reducer implantation Placebo Placebo Procedure Placebo procedure
- Primary Outcome Measures
Name Time Method Myocardial Blood Flow 6 months On cardiac MRI, with adenosine stress, millilitres/gram/minute
- Secondary Outcome Measures
Name Time Method Myocardial perfusion reserve (MPR) in ischaemic segments, non ischaemic segments and global MPR 6 months On cardiac MRI
Canadian Cardiovascular Society Class 6 months On a scale from 0-4 with higher scores indicating more severe angina
Angina symptom score 6 months Derived from ORBITA-COSMIC smartphone application
Seattle Angina Questionnaire (SAQ) Angina Frequency 6 months On a scale from 0-100, with higher scores indicating better outcomes
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
Endocardial:epicardial ratio of stress MBF 6 months On cardiac MRI
Episodes of angina component of angina symptom score 6 months Daily episodes recorded on ORBITA-COSMIC smartphone application
Absolute coronary flow on pressure/temperature wire assessment 6 months millilitres per minute
Endocardial:epicardial ratio of rest MBF 6 months On cardiac MRI
Myocardial strain 6 months On cardiac MRI
Myocardial scar burden 6 months On cardiac MRI
SAQ Quality of Life 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
Coronary flow reserve (CFR) on pressure/temperature wire assessment 6 months CFR assessed by a pressure and doppler sensor wire 6 months 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
Treadmill Exercise Time 6 months Modified Bruce Protocol
Absolute coronary resistance on pressure/temperature wire assessment 6 months mmHg/(L/min)
Microvascular resistance reserve on pressure/temperature wire assessment 6 months Index of microcirculatory resistance on pressure/temperature wire assessment 6 months 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
SAQ Angina Physical Limitation 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
Endocardial:epicardial ratio of MPR 6 months On cardiac MRI
Trial Locations
- Locations (5)
Basildon and Thurrock Hospitals NHS Foundation Trust
🇬🇧Basildon, United Kingdom
Royal Bournemouth Hospital
🇬🇧Bournemouth, United Kingdom
St George's Hospital
🇬🇧London, United Kingdom
Imperial College Healthcare NHS Trust
🇬🇧London, United Kingdom
The Royal Brompton Hospital
🇬🇧London, United Kingdom