ORBITA-COSMIC – Coronary sinus reducer Objective impact on Symptoms, MRI Ischaemia and microvascular resistance
Joint Research Compliance Office, Imperial College London
Duration of Study in the UK
2 years, 10 months, 3 days
A growing number of people are living with coronary artery disease. One of the main treatment aims in coronary artery disease is the prevention of angina (chest pain on exertion). Despite conventional treatment, approximately 10% of patients with coronary artery disease have ongoing chest pain (refractory angina). Until recently, these patients have had no available treatment options.
A novel treatment for refractory angina was developed in response to this unmet clinical need– the Coronary Sinus Reducer (CSR). It is an hourglass shaped, stainless steel mesh which is implanted in the coronary sinus (the vessel which drains blood from the heart muscle). This is a simple procedure under local anaesthetic which takes approximately 30 minutes. In a randomised, double-blinded trial in 2015, CSR improved angina compared to placebo.
The therapeutic mechanism of the CSR is unknown. It is thought to redistribute blood in the heart muscle, favouring the areas which were most in need, by reducing resistance to flow. This has never been demonstrated in humans. We will investigate the mechanism of the CSR for the first time, in patients with refractory angina, recruited from UK Tertiary Cardiothoracic Centres.
We will use MRI scans to visualise blood flow in the heart muscle, we will measure resistance to blood flow in the cardiac catheterisation laboratory using a coronary wire and we will also assess symptoms and exercise capacity. This trial will utilise a placebo control. The treatment arm will receive a CSR and the control arm will have a placebo procedure. Participants and researchers will be blinded. After a 6-month follow-up period the tests will be repeated.
This study will characterise the effect that the CSR has on patients with refractory angina, improve our understanding of its mechanism and advance our ability to target therapy in this under treated group of patients.
London - Riverside Research Ethics Committee
Date of REC Opinion
27 Mar 2021
Further Information Favourable Opinion