|Study Design||Recruitment of cases|
|Lipid Clinics Participating in the study||Follow-up|
|What is being measured?||Surveys Safeheart|
Sociodemographic, clinical data and outcomes, physical examination, food-frequency and physical activity questionnaires, and quality of life survey (SF-12) of subjects are obtained at inclusion and follow-up visits on a standardized form, and stored in a central database through a private internet website designed specifically for this project (See specific pdf attached). Study data is stored in a central database connected via internet by each local coordinator or sent to the CC-FHF where trained personnel coded the data. Standardized forms and manuals of operations were supplied by the CC-FHF to each Lipid Clinic.
The demographic and clinical characteristics of subjects include age, employment and educational status, medical history, especially cardiovascular and cancer diseases, cardiovascular risk factors (lipid profile, high blood pressure, type 2 diabetes, obesity, smoking status), physical examination and current treatment for hypercholesterolemia and other risk factors. History of cardiovascular disease was obtained from medical charts provided by the subjects at the moment of inclusion.
Physical examination included weight, height, body mass index and waist circumference. Blood pressure and heart rate are measured twice in the supine position with an OMRON MX3 sphygmomanometer.
Venous blood samples are taken after 12 hours of fasting. DNA is isolated from whole blood using standard methods. The genetic diagnosis of FH is made using a DNA microarray (Progenika SA, Bilbao, Spain) as previously described. Serum, plasma, blood lymphocyte and DNA samples are aliquotted and preserved at –80ºC until used. The Coordinating Centre also manage the sample collection and transportation, in collaboration with ICCC- Barcelona and is also responsible for quality control of information provided on biosample tube labels