Information for partners of MaGiCAD patients
Beginning in the Summer of 2003, the MaGiCAD team will begin contacting some of the partners of the MaGiCAD patients to ask you to help with the MaGiCAD study.
Why do you need to approach the partners of patients?
One of the aims of the MaGiCAD study is to examine potential new risk factors for the development of coronary artery disease. The only way to determine if a factor measured in patients with (suspected) coronary artery disease is a risk factor is to measure the presence of that factor in the normal population. The easiest way for us to obtain samples from a similar population to the patients attending Papworth Hospital is to approach the partners of the MaGiCAD patients.
MaGiCAD had already begun before we decided to approach the partners of MaGiCAD patients for our control samples. As we cannot approach any partner without the MaGiCAD patient having given prior consent, only partners of MaGiCAD patients from the later part of the study will be approached. From this latter half of the study, patients will be selected at random, with the only selection criteria being to balance the numbers of men and women to match that of the MaGiCAD study patients.
There is therefore no reason why you may or may not have been selected over and above that noted above. In addition, it does not matter if you feel you are healthy or not - what we need for MaGiCAD is a group of partners representative of the general population - and therefore some of you may even have heart disease! But you can still participate as a control for MaGiCAD.
Do I have to take part?
No. The study is entirely voluntary, and there will be absolutely no consequences in terms of you or your partners future health care whatever you decide to do.
What will happen to me if I take part?
If you are contacted by the MaGiCAD team and would like to participate as a partner in the MaGiCAD study, please return the enclosed slip as directed. You will then be contacted by telephone and an appointment arranged for you to come to Papworth Hospital and meet with Caryl Barnard, one of our Clinical Research Assistants. She will then go through a questionnaire with you, asking you a few simple questions (e.g about your family background and whether you smoke etc.) She will then arrange for you to give a small blood sample from a vein in your arm, and ask you to provide a urine sample.
Are there any benefits in taking part?
You will be paid your expenses for the day, to ensure that you are not out of pocket! However, there are no direct benefits of taking part in MaGiCAD: Partners. There will just be the satisfaction of helping the MaGiCAD team try and understand the factors involved in the development of heart disease.
Are there any risks in taking part?
There is virtually no risk in taking part in MaGiCAD: Partners. However, there may be some slight discomfort when the blood is collected, and following the blood collection there may be some bruising.
What will happen to the samples I have given, and will I know the results?
Firstly, your samples will be completely anonymised. On the day that you come to give your sample, your name will be replaced with a code number, so that the researchers who are analysing the data do not know who you are. There will be only one place where a list of names vs. code numbers will be stored, and that is at Papworth Hospital and is accessible only by Caryl and the other Clinical Research Assistants.
The samples that you provide will be stored for five years. Initially, a battery of standard clinical tests will be performed on your blood sample. This range of tests have been in standard use for many years. If any of the results are outside of the reference ranges, you and your GP may be informed of the result if the Doctor feels that the result is clinically relevant. However, this is the only way in which you will be informed of your results.
In the future, your blood sample may be used in other research tests, which do not have clinical reference ranges. Any use of your blood sample for a "non-standard" clinical blood test will have to be approved by the Local Research Ethics Committee (LREC). Currently, we have not requested approval for any non-standard clinical blood test, and we may not test for HIV or AIDS.