Clinical trial NCT04892537: Coronary Sinus Reducer Objective Impact on Symptoms, MRI Ischaemia and Microvascular Resistance
Official title: Coronary Sinus Reducer Objective Impact on Symptoms, MRI Ischaemia and Microvascular Resistance
Study type: INTERVENTIONAL
Overall status: RECRUITING
Phase: NA
Conditions: Refractory Angina
Lead sponsor: Imperial College London
Sponsor class: OTHER
Collaborators: name: Medical Research Council
name: Imperial College Healthcare Nissen Fund
First posted: 2021-05-19
Enrollment: 50
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

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.


Eligibility criteria: 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

Primary outcomes:
measure: Myocardial Blood Flow
timeFrame: 6 months
Secondary outcomes:
measure: Myocardial perfusion reserve (MPR) in ischaemic segments, non ischaemic segments and global MPR
timeFrame: 6 months
measure: Rest myocardial blood flow (MBF) in ischaemic segments, non ischaemic segments and global rest MBF
timeFrame: 6 months
measure: Stress myocardial blood flow (MBF) in ischaemic segments, non ischaemic segments and global stress MBF
timeFrame: 6 months
measure: MPR in ischaemic segments with inferior and inferoseptal segments excluded
timeFrame: 6 months
measure: MBF in ischaemic segments with inferior and inferoseptal segments excluded
timeFrame: 6 months
measure: Endocardial:epicardial ratio of stress MBF
timeFrame: 6 months
measure: Endocardial:epicardial ratio of rest MBF
timeFrame: 6 months
measure: Endocardial:epicardial ratio of MPR
timeFrame: 6 months
measure: Myocardial strain
timeFrame: 6 months
measure: Myocardial scar burden
timeFrame: 6 months
measure: Episodes of angina component of angina symptom score
timeFrame: 6 months
measure: Canadian Cardiovascular Society Class
timeFrame: 6 months
measure: Angina symptom score
timeFrame: 6 months
measure: Seattle Angina Questionnaire (SAQ) Angina Frequency
timeFrame: 6 months
measure: SAQ Angina Physical Limitation
timeFrame: 6 months
measure: SAQ Quality of Life
timeFrame: 6 months
measure: SAQ Treatment Satisfaction
timeFrame: 6 months
measure: SAQ Angina Stability
timeFrame: 6 months
measure: Euro-Qol (EQ-5D-5L) descriptive system
timeFrame: 6 months
measure: Euro-Qol (EQ-5D-5L) visual analogue scale
timeFrame: 6 months
measure: Angina related quality of life rated by the MacNew questionnaire
timeFrame: 6 months
measure: Treadmill Exercise Time
timeFrame: 6 months
measure: Absolute coronary flow on pressure/temperature wire assessment
timeFrame: 6 months
measure: Absolute coronary resistance on pressure/temperature wire assessment
timeFrame: 6 months
measure: Microvascular resistance reserve on pressure/temperature wire assessment
timeFrame: 6 months
measure: Coronary flow reserve (CFR) on pressure/temperature wire assessment
timeFrame: 6 months
measure: Index of microcirculatory resistance on pressure/temperature wire assessment
timeFrame: 6 months
measure: CFR assessed by a pressure and doppler sensor wire
timeFrame: 6 months
Other outcomes:
Locations:
city: Basildon
country: United Kingdom
facility: Basildon and Thurrock Hospitals NHS Foundation Trust
city: Bournemouth
country: United Kingdom
facility: Royal Bournemouth Hospital
city: London
country: United Kingdom
facility: Imperial College Healthcare NHS Trust
city: London
country: United Kingdom
facility: St George's Hospital
city: London
country: United Kingdom
facility: The Royal Brompton Hospital
Study officials:
References: