will be evaluated for coronary revascularization or angioplasty prior to and irrespective of the 
gene therapy. These patients will be considered candidates for gene therapy after this evaluation 
is completed and the recommendations are implemented (i.e., coronary revascularization, 
angioplasty, or medical therapy). 
Patients will also be evaluated for evidence of a second dyslipidemia or hepatobiliary 
disease. Evidence to suggest the presence of either concurrent condition will exclude the patient 
from participating in this study. 
An initial evaluation will be done 1 month prior to the procedure. The purpose of this 
evaluation is to establish the eligibility of the patient for the protocol and to establish baseline 
metabolic parameters. The patient will be placed on an American Heart Association Phase III 
diet 2 weeks prior to the initial evaluation. All drugs that may affect cholesterol metabolism 
and plasma exchange or LDL apheresis treatments will be discontinued two weeks prior to the 
visit. The following studies will be done: 
i. History and physical exam 
ii. General laboratory studies; and rule out hypothyroidism, azotemia, significant 
proteinuria, diabetes, obstructive hepatobiliary disease: 
CBC, platelets, differential 
Erythrocyte sedimentation rate (ESR) 
Complete urinalysis 
Test panel II; electrolytes, glucose, creatinine 
Test panel IV; calcium, phosphorus, protein, albumin, bilirubins, ALT, AST, 
alk phos, LDH, uric acid, 
Glycosylated hemoglobin 
TSH 
iii. Assess liver function; 
above, plus protein electrophoresis 
iv. Assess coagulation status: 
Prothrombin time 
Partial thromboplastin time 
Bleeding time 
v. Assess lipid/lipoprotein status: 
Fasting cholesterol, triglycerides, HDL-C, LDL-C 
Lipoprotein electrophoresis 
LPP fractionation 
CHOL & TG in LDL, IDL, VLDL, HDL, and chylos 
Apo Al, AIV, B1 00, Cll, Clll, E, Al, A2 
Free fatty acids 
vi. Assess other atherogenic potentials: 
Fibrinogen 
PA I 
LP (a) 
vii. Cardiac evaluation: 
EKG 
Echo with Doppler 
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Recombinant DNA Research, Volume 15 
