lotsofkids
MM.com Benefactor
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Moyamoya...Oh boya boya!
Posts: 333
Akron, USA, usa, 421, 123, OH, Ohio
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Hi guys....this is probably a bit long...but it is the original protocol / consent from the study hope this helps....I will post back soon as I hear some info: thanks
EMAIL FROM DR. BOURGEOIS APRIL 07
Bourgeois.Scott@uth.tmc.edu
You are being invited to take part in this study because you or a family member has vascular disease, such as coronary artery disease, a stroke, or peripheral vascular disease. This research project is being conducted by Dr. Dianna M. Milewicz from the University of Texas Medical School at Houston. Your decision to take part is voluntary and you may refuse to take part, or choose to stop taking part, at any time. A decision not to take part, or to stop being a part of the research project, will not change the services that are available to you from the physicians or hospital. You may refuse to answer any questions asked or written on any forms. This research project has been reviewed by the Committee for the Protection of Human Subjects (CPHS) of the University of Texas Health Science Center at Houston as HSC-MS-06-0564. PURPOSE OF STUDY: The primary goal of this study is to identify the genes that, when altered, lead to vascular diseases such as coronary artery disease, strokes or peripheral vascular disease. INCLUSION CRITERIA (1) Sbjects with premature onset of vaso-occlusive disease (defined as <55 years of age for males and <60 yars of age for females), including strokes, coronary artery disease, and peripheral vasculardisease. (2) Patients with the diagnosis of Sneddon’s syndrome. (3) Patients with the diagnosis of Moyamoya disease. (4) Children with vaso-occlusive disease, including stroke. (5) Family members of patients with a family history of vaso-occlusive disease or mutation. EXCLUSION CRITERIA Individuals who do not have a vascular disease, premature vaso-occlusive disease or do not have a family history of it or any of the above mentioned conditions. The tissue collected from you will be used to grow cells for further studies. The cells may be kept frozen for further study at a later time. The cells and DNA samples will be banked for studies until the sample is gone, which may take years. The samples and medical information from the questionnaires may be shared with other investigators at other sites who are studyingindividuals with aortic aneurysms and dissections but your name and any other information that can identify you will not be shared and will be kept confidential. If you leave outside of the Houston area, we will send you a kit to collect saliva, and a prepaid mailing kit to send it back to us. Alternatively, your physician may draw your blood and send it to us. You will be asked to donate samples only once if there are no problems with the laboratory analysis of your samples. Your medical records will be obtained from your primary doctor. These studies may determine if you have an alteration in a gene or protein. Any results will be reported back to you or your physician. The tests that we do will be done in a research lab and should not be used to make any clinical decisions until the results are confirmed by a clinical lab. Information on how and where to send your samples for confirmation of your results by a clinical lab will be provided to you. It is possible that this study will identify information about you that was previously unknown, such as information about a predisposition to a disease. Such incidental findings, if any, will not be shared with you or anyone related to you unless the incidental finding is a risk for a disease known at the time of testing to be likely to cause premature death if untreated. Should such lifethreatening results be uncovered through these research studies, you will be notified via certified mail and/or phone call. Genetic counseling will be provided to you and your family members to explain these results.
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