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Logistics and Management

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The Samara Study has completed Phase I patient enrollment and genomic data collection. Phases I and II are outlined below.

Samara I Defined Population

Two hundred male and female patients of any ethnic background, 21 to 50 years of have been recruited from the University of North Carolina at Chapel Hill (UNC) cardiac catheterization laboratory. One group consisted of individuals with stenosis of greater than or equal to 70 percent in one major epicardial coronary artery (single-vessel coronary disease) while a second group consisted of individuals with stenosis of greater than or equal to 70 percent in two or more major epicardial coronary arteries (multi-vessel coronary disease). A third group consisted of patients with or without coronary disease who have peripheral vascular disease defined as 50% or greater lesion in a renal, iliac, femoral or subclavian artery. A fourth group consisted of patients with mild vascular disease. Lastly, a "control" group consisted of patients whose coronary arteries are angiographically normal (<10% stenosis).

The inclusion criteria were designed to be broadly applicable. They included age between 21 and 50, and presence of vascular disease or normal control as defined above. Older individuals were not included in order to establish a more homogeneous population in which to examine gene expression.

Exclusion criteria included prior heart transplantion (coronary artery disease in transplanted hearts is thought to be different in etiology than atherosclerotic disease). Pregnant women were excluded from this study (because of the radiation exposure, very few if any pregnant women undergo cardiac catheterization). In addition, individuals with hematocrit less than 28% were excluded.

Samara II Defined Population

Two hundred male and female patients of any ethnic background, greater than 65 years of age are being recruited from the University of North Carolina at Chapel Hill (UNC) cardiac catheterization laboratory. One group consists of individuals with stenosis of greater than or equal to 70 percent in one major epicardial coronary artery (single-vessel coronary disease) while a second group consists of individuals with stenosis of greater than or equal to 70 percent in two or more major epicardial coronary arteries (multi-vessel coronary disease). A third group consists of patients with or without coronary disease who have peripheral vascular disease defined as 50% or greater lesion in a renal, iliac, femoral or subclavian artery. A fourth group consists of patients with mild vascular disease. Lastly, a "control" group consists of patients whose coronary arteries are angiographically normal (<10% stenosis).

The inclusion criteria are designed to be broadly applicable. They include age greater than 65, and presence of vascular disease or normal control as defined above. Younger individuals are not included in order to establish a more homogeneous population in which to examine gene expression.

Exclusion criteria are as described above for Phase I, and include prior heart transplantion (coronary artery disease in transplanted hearts is thought to be different in etiology than atherosclerotic disease). Pregnant women will be excluded from this study (because of the radiation exposure, very few if any pregnant women undergo cardiac catheterization. Moreover, there are very few pregnant women in the age group being studied). In addition, individuals with hematocrit less than 28% will be excluded.

 

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