ClinSeq: A Large-Scale Medical Sequencing Clinical Research Pilot Study
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Study Eligibility
We plan to recruit a cohort whose risk to develop coronary artery disease will range from less than 5 percent, based on the 10-year-risk provided by the Framingham risk score, to greater than 10 percent, and including those with known coronary artery disease. The 10-year-risk will be measured by the Framingham risk score based on LDL cholesterol levels.
Individuals eligible for this study will be 45 to 65 years of age or older. We selected this cutoff as we are interested in recruiting a cohort whose coronary artery calcification (CAC) measurements range from normal to diseased, and it has been shown that abnormal CAC is infrequent below this age. Also, individuals eligible for this study will be required to have a primary care physician or equivalent with whom we can communicate in the event we uncover a condition that merits follow-up. Additionally, individuals eligible for this study will be required to be non-smokers, for our purposes defined as someone who has not smoked during the previous 12 months.
Due to the large number of individuals to be recruited and the intention to follow this cohort longitudinally, we will focus our efforts on the metropolitan Washington D.C. and Baltimore areas (in order to minimize reluctance to participate because of travel limitations). If recruitment is below anticipated levels, we may seek additional subjects from the Richmond, Va. metropolitan area. Individuals who are not local to these areas may be considered for participation if they are part of other protocols within the National Heart Lung and Blood Institute (NHLBI), and travel to the National Instiutes of Health (NIH) Clinical Research Center on a regular basis for follow-up, or if they are willing to travel to the NIH as needed for protocol participation (at their own expense).
An eligibility screen will be performed by telephone to ascertain age, basic demographics, smoking history and presence or absence of known cardiovascular disease. We intend to recruit persons of both sexes, of diverse ethnic and racial categories, and from various socio-economic backgrounds.
Last Updated: February 4, 2009
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