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Cardiovascular Evaluation of Patients with High Cholesterol and Normal Volunteers



Cardiovascular Evaluation of Patients with High Cholesterol and Normal Volunteers

For Condition: Atherosclerosis,Hypercholesterolemia
Status: Recruiting
Sponsor(s): National Heart, Lung, and Blood Institute (NHLBI) ,
Synopsis: Homozygous familial hypercholesterolemia is a rare inherited disease of metabolism. It occurs in less than 1 in 1 million people within the United States. Patients with the disease are typically children and young adults who develop heart disease early in life. Children less than age 5 years with this disease have suffered heart attacks and death. The normal process that removes cholesterol particles from the blood stream does not work in patients with this disease. It causes cholesterol to build-up in the arteries and leads to hardening of the arteries (atherosclerosis). The goal of this study is to detect and measure atherosclerosis in these patients before it becomes permanent and potentially life threatening. Patients with this disease can participate in this study. Researchers plan to evaluate patients with homozygous familial hypercholesterolemia using new and standard methods for detecting atherosclerosis. Researchers plan to use information gathered during this study to develop new, promising treatments such as liver transplantation and gene therapy.
Details: Familial hypercholesterolemia is an autosomal co-dominant disorder resulting in abnormal LDL receptor function, profoundly elevated concentrations of low density lipoproteins, accelerated atherosclerosis and death by early adulthood. This disease is heterogeneous in both the degree of LDL receptor dysfunction as well as the age of death. Liver transplantation has been demonstrated to virtually normalize plasma lipoprotein concentrations in homozygous FH and the recent cloning of a functional LDL receptor gene holds promise in the definitive treatment of this condition. We propose performing longitudinal sequential cardiologic studies utilizing noninvasive techniques in homozygous patients with well-characterized LDL receptor defects. Sequential cardiovascular study of these patients will not only characterize the progression of atherosclerosis heart disease in this disease, it may also permit the identification of individuals with would be likely to benefit from liver transplantation and/or genetic engineering.
Eligibility:
Study Type:  Observational, Natural History
Minimum Age/Maximum Age: /
Genders: Both
Protocol Entry Criteria: INCLUSION CRITERIA: Fasting cholesterol greater than 500 mg/dl, low density lipoprotein cholesterol greater than 400 mg/dl, and triglycerides less than mg/dl. Family history of hypercholesterolemia and/or cardiovascular disease before the age of 60 years. Tendinous and tuberous xanthomas. Arcus corneae before the age of 30.
Total Enrollment: 95

Location and Contact Information:

National Heart, Lung and Blood Institute (NHLBI) *Recruiting*
Bethesda,  Maryland,  20892
United States
Recruiting Patient  and Public Liaison Office 1-800-411-1222


Additional Information:
Study ID Numbers:  850105;  85-H-0105
Study Start Date: May 28, 1985
Record last reviewed: April 24, 2003
Additional information available at: clinicaltrials.gov
Clinicaltrials.gov Reference link: NCT00001204

Other Hypercholesterolemia Studies:
1. Evaluation of the Safety & Efficacy of a Combination of Niacin ER & Simvastatin in Patients with Dyslipidemia (OCEANS)

2. Computed Tomography (CT)--An Epidemiologic Study in the Young

3. Genetic Mapping of Atherogenic Lipoprotein Phenotypes

4. The Role of Angiotensin Type I Receptor in the Regulation of Human Coronary Vascular Function

5. Racial Differences in Control of Blood Vessel Tone and Blood Flow

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