Interventional Recruiting
NCT04892537 on ClinicalTrials.gov
Coronary Sinus Reducer Objective Impact on Symptoms, MRI Ischaemia and Microvascular Resistance
- Sponsor: Imperial College London
- Collaborators: Medical Research Council, Imperial College Healthcare Nissen Fund
- Enrollment: 50 (Estimated)
- Study start: 2021-05-21 (Actual)
- Primary completion: 2024-01-01 (Estimated)
- Study completion: 2024-01-01 (Estimated)
- Allocation: Randomized
- InterventionModel: Parallel
- Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
- PrimaryPurpose: 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.
Conditions
- Refractory Angina
Intervention / Treatment
- Device: Coronary Sinus Reducer
- Procedure: Placebo Procedure
Primary Outcome Measures
-
Myocardial Blood Flow
(6 months)
On cardiac MRI, with adenosine stress, millilitres/gram/minute
Countries
United Kingdom
Locations and Investigators
-
Basildon and Thurrock Hospitals NHS Foundation Trust, Basildon, United Kingdom (Not yet recruiting)
- John Davies, PhD
-
Royal Bournemouth Hospital, Bournemouth, United Kingdom (Not yet recruiting)
- Peter O'Kane
-
Imperial College Healthcare NHS Trust, London, United Kingdom (Recruiting)
- Rasha Al-Lamee, PhD MRCP
- Michael Foley, MBBS MRCP
-
St George's Hospital, London, United Kingdom (Not yet recruiting)
- James Spratt, MbChB MD
-
The Royal Brompton Hospital, London, United Kingdom (Not yet recruiting)
- Jonathan Hill