Coronary Sinus Reducer Objective Impact on Symptoms, MRI Ischaemia and Microvascular Resistance

Launched by IMPERIAL COLLEGE LONDON · May 14, 2021

Keywords

ClinConnect Summary

The ORBITA-COSMIC clinical trial is studying a device called the coronary sinus reducer (CSR) to see how it affects patients with refractory angina, which is chest pain that doesn't go away with standard treatment. This study will compare the effects of the CSR to a placebo (a treatment with no active ingredients) in 50 participants. Researchers will look at how well the heart is getting blood flow using MRI scans, how long participants can exercise, and how their symptoms improve.

To be eligible for this trial, participants should be between 65 and 74 years old and have stable coronary artery disease that isn't suitable for other procedures like heart surgery or stenting. They must also have evidence of reduced blood flow to the heart and experience angina classified as moderate to severe, despite taking the best available medications. If you or a loved one meet these criteria, the trial offers a chance to explore a new treatment option and contribute to important heart health research. Participants will be closely monitored throughout the study, and their experiences will help us understand the potential benefits of this new device.

Gender

ALL

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