Extrait

Background and study aims Coronary heart disease (CHD), also known as ischemic heart disease, is one of the leading causes of death worldwide. CHD develops because of the build-up of fatty deposits (plaque) on the walls of the coronary arteries (the arteries that supply the heart with oxygen-rich blood). When arteries are blocked or narrowed, the heart does not receive enough blood to function properly, which can cause pain and tightness in the chest (angina). Refractory angina (RA) is a form of angina where usual treatments such as coronary artery bypass grafts (an operation in which a blood vessel from another part of the body is attached to the coronary artery above and below the blocked or narrowed area so that blood is diverted around the blockage) are ineffective. As RA is so difficult to treat, it can be extremely disabling for patients, involving frequent hospital visits and a reduced quality of life. Spinal cord stimulation (SCS), sometimes called neuromodulation, is a treatment used for people with long-term (chronic) debilitating pain conditions. It involves implanting a ‘pacemaker-like’ box under the skin and connecting it using leads and electrodes to the nerves of the spine (spinal cord) at chest level. Although a small number of UK centres currently provide this treatment, it has not yet become accepted practice in the treatment of RA. The aim of this study is to look at the effectiveness of SCS in the treatment of patients with RA. Who can participate? Adults suffering from CHD with RA. What does the study involve? Participants are randomly allocated to one of two groups. Participants in the first group (intervention group) undergo an operation so that the spinal cord stimulator (SCS) device can be implanted and connected to the spinal cord. The participants in this group also continue to receive usual medical care, including pain relief medications and educational sessions with a pain consultant. Participants in the second group receive normal care alone, which consists of pain relief medications, educational sessions with a pain consultant and the option to use a TENS machine (a device designed to provide pain relief using electrical stimulation to the skin). At the start of the study and then again after six months, participants in both groups complete a number of questionnaires in order to assess their pain levels and quality of life. What are the possible benefits and risks of participating? Not provided at time of registration Where is the study run from? South Tees Hospitals NHS Foundation Trust (UK) When is the study starting and how long is it expected to run for? May 2011 to July 2013 Who is funding the study? National Institute for Health Research (UK) Who is the main contact? Dr Sam Eldabe [email protected]

Critère d'inclusion

• Refractory Angina

Liens

• isrctn
• ictrp