Extrait

Background and study aims In this study, we aim not only to measure the effects of arthritis treatment, including the effect of the drug etanercept, but also to look at the effect it has on the heart and blood vessels. This is important because, in long-term rheumatoid arthritis, there is an increased risk of heart disease and disorders of blood vessels, such as stroke. This study will use MRI scanning technique to provide an insight into heart disease in patients with rheumatoid arthritis and allow us to study the effects of early biologic treatment. Who can participate? Men and women, aged between 18 and 80 years, diagnosed with rheumatoid arthritis, who have not yet received a drug treatment and who have disease symptoms for less than 1 year can participate in this study. We also enroll men and women without rheumatoid arthritis, aged between 18 and 80 years for comparison. What does the study involve? All participants receive Magnetic Resonance Imaging (MRI) of the heart at the start of the study and then at end of year 1 and end of year 2. MRI is a widely used and safe technique for imaging soft tissues within the body. MRI can assess what the blood vessels look like and how well the heart functions. Up to 20 ml (approximately 2 tablespoons) of extra blood will be taken at three of the study visits. This will be tested in this sub-study, but it will also be stored (in an anonymised way, i.e. your identity will not be shown on the samples) for possible future research. Pulse Wave Velocity measurements are taken to find out how fast blood travels from one point in the body to the next. Blood travels faster if blood vessels are stiffer, and stiffer blood vessels suggest a higher risk of heart disease. What are the possible benefits and risks of participating? Patients may receive beneficial information about the disease. This study may help us to better treat patients in the future. No personal benefits will be gained directly by the patients. Collection of blood may cause symptoms such as local pain, bleeding, bruising, fainting, and rarely infection. Magnetic Resonance Imaging (MRI) is safe and no radiation is used for this scan. There are no known risks from this technique. Some people may experience claustrophobia (discomfort of being in a closed space). Our MRI staff will do all that they can to make you feel comfortable during the scan, and will be monitoring you via a video camera and an audio link. If we are unable to make you feel comfortable in the scanner, we will not go ahead with scanning. The medication which we use is very safe but, as with any injection, reactions may occur. These include a warm sensation at the injection site, nausea or vomiting and skin rash. These effects usually only last for a few minutes. People with a history of allergy are more likely to suffer a more severe reaction, but this is rare (less than 1 in 3000). The department is equipped to cope with allergic reactions if they happen and medical staff will be on hand to deal with any unforeseen circumstances or problems. Adenosine, the medication we use to increase the blood flow to the heart, can cause flushing, breathlessness and chest discomfort. However, all of these feelings usually subside within one or two minutes or even more quickly if the medication is stopped Where is the study run from? The study is run from Chapel Allerton Hospital and The Leeds General Infirmary, both located in Leeds, UK. When is the study starting and how long is it expected to run for? The study started in July 2011 and expected to run until March 2016. Who is funding the study? The study is funded by the National Institute for Health Research (NIHR), UK. Who is the main contact? Prof. Sven Plein Tel: 0113 3925404 Fax: 0113 3925405 E-mail: [email protected]

Critère d'inclusion

• Topic: Cardiovascular; Subtopic: Cardiovascular (all Subtopics); Disease: Atherothrombosis

Liens

• isrctn
• ictrp