Status:
UNKNOWN
Coronary Sinus Reducer Objective Impact on Symptoms, MRI Ischaemia and Microvascular Resistance
Lead Sponsor:
Imperial College London
Collaborating Sponsors:
Medical Research Council
Imperial College Healthcare Nissen Fund
Conditions:
Refractory Angina
Eligibility:
All Genders
18+ years
Phase:
NA
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...
Eligibility Criteria
Inclusion
- 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
- 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
Key Trial Info
Start Date :
May 21 2021
Trial Type :
INTERVENTIONAL
Allocation :
ESTIMATED
End Date :
January 1 2024
Estimated Enrollment :
50 Patients enrolled
Trial Details
Trial ID
NCT04892537
Start Date
May 21 2021
End Date
January 1 2024
Last Update
October 30 2023
Active Locations (5)
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1
Basildon and Thurrock Hospitals NHS Foundation Trust
Basildon, United Kingdom
2
Royal Bournemouth Hospital
Bournemouth, United Kingdom
3
Imperial College Healthcare NHS Trust
London, United Kingdom
4
St George's Hospital
London, United Kingdom