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临床试验/NCT00065793
NCT00065793已完成不适用

VLDL and LDL Particle Types as Coronary Heart Disease Risk Factors

Brigham and Women's Hospital0 个研究点目标入组 1,478 人开始时间: 2003年7月最近更新:
适应症

试验速览

阶段
不适用
状态
已完成
入组人数
1,478
主要终点
apoB concentration of LDL with apoC-III

研究概览

简要总结

To evaluate very low density lipoprotein (VLDL) and low density lipoprotein (LDL) particle types as predictors of initial coronary events.

详细描述

BACKGROUND:

Plasma triglyceride concentration is an independent although relatively weak risk factor for coronary heart disease (CHD). The relative weakness of plasma triglycerides to predict CHD may be due to the substantial diversity of lipoprotein particles that carry the triglycerides, some being related to atherosclerosis and CHD more than others. The investigators have shown in patients who have had a myocardial infarction that the rather weak association between triglycerides and subsequent coronary events is secondary to a stronger relationship with specific types of VLDL remnants, those in the LDL density range that contain apoCIIl.

DESIGN NARRATIVE:

The study will evaluate VLDL and LDL particle types as predictors of initial coronary events in men from the Health Professional Follow-up Study (HPFS) and women from the Nurses Health Study (NHS). A prospective nested case-control design will be used with a total of 1000 CHD cases and 1000 matched controls, with equal numbers of men and women. The investigators will specifically investigate the role of apoCIII containing VLDL and LDL particles in diabetes by over sampling so that 50% of the patients will have type 2 diabetes mellitus. Their previous work shows that LDL apoCIII particles are independent predictors of recurrent CHD in diabetic patients who survived a myocardial infarction. They hypothesize that apoCIII may have a special role in dyslipidemia and CHD in diabetes. Secondary Aims: Besides apoCIII, other small apolipoproteins, apo C1, CII, and All are components of VLDL and LDL and modulate the metabolism of apoB lipoproteins. It is likely that these apolipoproteins have a relationship with human atherosclerosis. They will measure these apolipoproteins in VLDL and LDL and evaluate their relationship to CHD. They will also investigate the associations between these new lipoprotein risk factors and intake of foods and nutrients, physical activity, and other risk factors, including smoking, BMI, age and gender. The results will provide new means to identify nondiabetic and diabetic persons who are at high risk of developing CHD and the environmental determinants, and could form the basis for new lipoprotein targets for lipid management by diet and medicines.

研究设计

研究类型
Observational
观察模型
Cohort
时间视角
Prospective

入排标准

性别
All
接受健康志愿者

入选标准

  • 未提供

排除标准

  • 未提供

结局指标

主要结局

apoB concentration of LDL with apoC-III

时间窗: 10-14 years

observational follow-up for coronary events

次要结局

未报告次要终点

研究者

申办方类型
Other
责任方
Principal Investigator
主要研究者

Frank M. Sacks

Professor of Medicine

Brigham and Women's Hospital

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