Prospective
Thinking of taking part in OMA? Thank you for the consideration!
What is the research study about?
Chest pain is a worrying symptom and in some people it may be caused by heart disease and is called angina. This is a pain or discomfort in the chest caused by narrowing of the coronary arteries of the heart. Your GP has referred you to a clinic to investigate this further. By collecting detailed information from patients at the clinic we hope to develop new ways of diagnosing symptoms like the ones you experience. We want to study how blood tests might help in diagnosis in order to improve chest pain care in the future. We would also like to look at your health before and after the clinic to help with this. We would like our findings to enhance early detection and better care of people with chest pain and angina.
What will happen if I agree to participate in the study?
When you arrive at the clinic you will be met by a research nurse who will discuss the study further with you. If you agree to participate you will be asked to sign a consent form to indicate that you understand what the study involves. A sample consent form is enclosed for you to have a look at.
The nurse will ask you to complete a questionnaire using a touch-screen device, take some clinical measurements, such as your blood pressure, waist and hip size, body fat, lung function, ECG heart rhythm tracing and a blood sample. Following this you will attend your normal clinic appointment. Your appointment will not be affected by your decision to take part or not in the study.
What will the questionnaire involve?
We will ask you a series of questions, firstly about your chest pain, and then about your day-to-day life. The nurse will show you how to use a touch-screen device to give your answers, so you will not be asked to write anything down. If you have any difficulty with the questions or with the device, the nurse will be available to help you. It will take a minimum of 30 minutes to complete.
We will also ask your permission to send you another short questionnaire 3 months after the clinic appointment, and a final questionnaire possibly some years after that to find out about your symptoms and the impact they may be having on you.
Why will a blood sample be taken?
For many medical conditions, tests are carried out in order assess future risk and severity of a condition, by measuring substances (‘biomarkers’) in the blood. For people experiencing chest pain, we need to know more about biomarkers and in particular, which ones could help clinical care. Therefore we would like to measure the levels of a number of biomarkers in the blood samples we collect in this study.
We would also like to look at some genetic biomarkers, using DNA from your blood sample. Different people have different combinations of genes. Studying this information may help to identify if some people are more at risk of angina than others, so that new treatments can be developed.
The results of all these tests will remain confidential and be used for research purposes only. Your GP will not be informed of these results and they will not be put on your medical record, or passed on to any third parties including insurance companies. You will not be notified of the results of any of the tests performed as part of the research. This is a long-term study, so it is possible that your sample may be tested after some years have passed. All samples will be securely stored in a ‘biobank’.
Will my personal information be kept safe?
Absolutely. We will keep your blood samples and questionnaire data in secure facilities. They will only be accessible by staff who are part of the research team. Your personal information (such as your name and address) will be kept securely and separately from the rest of the information collected. We will ensure that you cannot be identified from the information you provide only anonymised data will be analysed by researchers, which is strictly confidential.
Will any information from the study be given to clinic staff or my GP?
None of the information that you provide to the research team (including the questionnaire, clinical measurements, blood sample results or from the further assessments) will be passed on to the clinic staff or your GP at any time. The information will not be used to influence any treatment decision.
With your permission we will inform your GP that you are participating in the research study. Your GP will already be aware that a research study is being undertaken at your local chest pain clinic. Please continue to tell your GP about any symptoms or changes in your health that are worrying you.
What will happen if I decide not to participate in the study?
You will have a normal appointment at the chest pain clinic and there will be no difference in the care you receive from the clinic staff. We will not contact you again.
Can I withdraw from the study?
You can withdraw from the study at any time, without giving a reason and your normal care will not be affected. If you choose to withdraw, we will not contact you again.
Who is running this study?
This study has been designed by a group of researchers from University College, London, The University of Bristol and Queen Mary University of London. The research is funded by money from the National Institute for Health Research (NIHR) which is part of the NHS. All research in the NHS is looked at by an independent group of people, called a Research Ethics Committee, to protect your safety, rights, wellbeing and dignity. This research has also been reviewed and designed with the help of a Patient User Involvement Group which includes patients who have suffered chest pain and had experience of chest pain clinics.
What if I have more questions?
You will have the chance to talk with a research nurse when you arrive at the clinic, before deciding whether or not to join the study. Alternatively, you can contact us.
