Evaluating the impact of a coronary sinus reducer on symptoms and heart function in patients with refractory angina
Coronary Sinus Reducer Objective Impact on Symptoms, MRI Ischaemia and Microvascular Resistance
This study is testing whether a device called a coronary sinus reducer can help people with severe chest pain and heart issues feel better and improve their heart function.
Quick facts
| Phase | Not applicable |
|---|---|
| Study type | Interventional |
| Enrollment | 50 (estimated) |
| Ages | 18 Years and up |
| Sex | All |
| Sponsor | Imperial College London Academic / other |
| Locations | 5 sites (Basildon and 4 other locations) |
| Trial ID | NCT04892537 on ClinicalTrials.gov |
What this trial studies
This trial, known as ORBITA-COSMIC, is a randomized, double-blinded, placebo-controlled investigation that aims to assess the effects of a coronary sinus reducer (CSR) compared to a placebo in patients suffering from refractory angina and myocardial ischaemia. The study will involve 50 participants who will undergo MRI to evaluate myocardial perfusion, exercise capacity, and symptom relief. Participants must have stable coronary artery disease and be on maximal medical therapy, but not eligible for surgical interventions. The trial will provide insights into the potential benefits of CSR in improving heart function and alleviating symptoms.
Who should consider this trial
Good fit: Ideal candidates for this study are adults with stable coronary artery disease who experience refractory angina and have evidence of ischaemia on stress perfusion CMR.
Not a fit: Patients who may not benefit from this study include those with severe left ventricular impairment, recent acute coronary syndrome, or contraindications to cardiac MRI.
Why it matters
Potential benefit: If successful, this study could provide a new treatment option for patients with refractory angina, potentially improving their quality of life and heart function.
How similar studies have performed: While the specific approach of using a coronary sinus reducer is novel, similar studies exploring interventions for refractory angina have shown promising results.
Eligibility criteria
Show full inclusion / exclusion 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
Where this trial is running
Basildon and 4 other locations
- Basildon and Thurrock Hospitals NHS Foundation Trust — Basildon, United Kingdom (Not_yet_recruiting)
- Royal Bournemouth Hospital — Bournemouth, United Kingdom (Not_yet_recruiting)
- Imperial College Healthcare NHS Trust — London, United Kingdom (Recruiting)
- St George's Hospital — London, United Kingdom (Not_yet_recruiting)
- The Royal Brompton Hospital — London, United Kingdom (Not_yet_recruiting)
Study contacts
- Study coordinator: Rasha Al-Lamee, PhD MRCP
- Email: r.al-lamee13@imperial.ac.uk
- Phone: 020 7594 5735
How to participate
- Review the eligibility criteria above with your treating physician.
- Visit the official trial page on ClinicalTrials.gov for the most current contact information and recruitment status.
- Contact the listed study coordinator or principal investigator to request pre-screening. Pre-screening is free and never obligates you to enroll.