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Home > "A" Clinical Trials Conditions > Antioxidants and Prevention of Early Atherosclerosis  Antioxidants and Prevention of Early Atherosclerosis
Antioxidants and Prevention of Early Atherosclerosis
For Condition: Cardiovascular Diseases,Carotid Artery Diseases,Cerebral Arteriosclerosis,Cerebrovascular Disorders,Heart Diseases,Vascular Diseases,Atherosclerosis
Status: Suspended
Sponsor(s): National Heart, Lung, and Blood Institute (NHLBI) ,
Synopsis: To evaluate the effects of vitamin E supplementation in retarding the progression of common carotid artery intima-media thickening in African Americans.
Details: BACKGROUND: Evidence from epidemiologic studies and from one unpublished trial suggests that greater intake of antioxidant vitamins is associated with reduced risk of coronary heart disease and stroke. Findings from an animal model indicate that increased intake of antioxidant vitamins prevents progression of aortic fatty streaks induced by an atherogenic diet, but not from more advanced injury-induced lesions. These observations suggest the hypothesis that increased antioxidant vitamin intake may prevent further progression of early atherosclerosis, possibly by means of reduced susceptibility of low density lipoprotein to oxidative modification and consequent cytotoxic, chemotactic, chemostatic, and unregulated uptake effects. A new, automated, low-cost, portable ultrasound system for determining intima-media thickness of the common carotid artery makes it feasible to test the primary prevention impact of antioxidant vitamins on early atherosclerosis. Results of two trials at the University of Southern California suggest that the low density lipoprotein efffects on common carotid artery intima-media thickness can be detected by automated methods within twelve to twenty-four months in small patient samples. Retardation of intima-media thickness progression was achieved in both studies without significant changes in average vessel diameter -- suggesting effects on early atherosclerotic lesions. DESIGN NARRATIVE: Subjects will be screened for carotid intima-media thickness at home or at schools in mobile vans equipped with portable ultrasound equipment. After twelve months, those subjects above the age and sex-adjusted 66th percentile at Screen I will be re-screened (Screen II) and those showing the greatest progression in intima-media thickness will be invited to participate in a trial run-in to assess vitamin E compliance. Subjects will be randomized to 4 groups: vitamin E (573 mg/day), vit. C , Vit. E and C combined, and placebo. Common carotid artery intima-media thickness will be observed by ultrasound at twelve and twenty-four month follow-ups. The primary outcome will be twenty-four month rate of change in average common carotid artery intima-media thickness.
Eligibility:
Study Type: Interventional, Prevention, Randomized, Placebo Control
Minimum Age/Maximum Age: 35 Years/59 Years
Genders: Both
Protocol Entry Criteria: African American men and women, ages 35 to 59.
Total Enrollment:
Location and Contact Information:
Additional Information:
Study ID Numbers: 106;
Study Start Date: June 1995
Record last reviewed: November 2001
Additional information available at: clinicaltrials.gov
Clinicaltrials.gov Reference link: NCT00000600
Other Cardiovascular Diseases Studies:
1. Asymptomatic Carotid Artery Plaque Study (ACAPS)
2. Coronary Artery Calcium, Exercise Tests, and CHD Outcome
3. Treatment for Movement Problems in Elderly Stroke Patients
4. Jackson Heart Study (JHS)
5. Predictors of Recurrent Stroke in the PROGRESS Study
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Antioxidants and Prevention of Early Atherosclerosis
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