We'd like your feedback
Your feedback is important to us. It will help us improve the quality of the study information on this site. Please answer both questions.
Contact the study team using the details below to take part. If there are no contact details below please ask your doctor in the first instance.
Ischaemic heart diseases
This information is provided directly by researchers, and we recognise that it isn't always easy to understand. We are working with researchers to improve the accessibility of this information. In some summaries, you may come across links to external websites. These websites will have more information to help you better understand the study.
A growing number of people are living with coronary artery disease. One of the main treatments 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.
MRI scans will be used 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.
Start dates may differ between countries and research sites. The research team are responsible for keeping the information up-to-date.
The recruitment start and end dates are as follows:
Interventional type: Device;
You can take part if:
You may not be able to take part if:
• 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
Below are the locations for where you can take part in the trial. Please note that not all sites may be open.
The study is sponsored by Imperial College of Science, Technology and Medicine and funded by IMPERIAL COLLEGE HEALTHCARE CHARITIES; Medical Research Council (MRC); .
Your feedback is important to us. It will help us improve the quality of the study information on this site. Please answer both questions.
Read full details
for Trial ID: CPMS 49243
You can print or share the study information with your GP/healthcare provider or contact the research team directly.
