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临床试验/NCT07169266
NCT07169266进行中(未招募)不适用

Very Large Database of Lipids (VLDL)

Johns Hopkins University1 个研究点 分布在 1 个国家目标入组 5,051,467 人开始时间: 2006年4月1日最近更新:

试验速览

阶段
不适用
状态
进行中(未招募)
入组人数
5,051,467
试验地点
1
主要终点
Low-density lipoprotein cholesterol level

研究概览

简要总结

Closer examination of granular lipid data in a large population offers numerous opportunities to generate new knowledge, ranging from studies examining concordance between commonly used lipid parameters to phenotypic characterization of rare or extreme disorders of lipid metabolism, opening possibilities to better personalize future treatment of abnormal blood lipids.

STUDY POPULATION:

The Very Large Database of Lipids (VLDL) includes adults and children who were clinically referred for a Vertical Auto Profile (VAP). Patient samples originated predominantly from outpatient primary care clinics in the U.S. (85%), along with specialty clinics and inpatient settings.

LIPID MEASUREMENTS:

The VAP test (VAP Diagnostics Lab, Birmingham, Alabama, USA) directly measures cholesterol concentrations of low density lipoprotein, very low density lipoprotein, intermediate density lipoprotein, high density lipoprotein, their subfractions, and lipoprotein(a). Triglycerides in the database are directly measured using the Abbott ARCHITECT C-8000 system (Abbott Park, Illinois, USA). Lipid distributions in the database closely match those from the population-representative National Health and Nutrition Examination Survey (NHANES).

STUDY PROCEDURES:

This database was investigator-initiated. Only de-identified data reach the investigational site. The master database is housed at The Johns Hopkins Hospital in Baltimore, Maryland, and maintained by Drs. Jones and Martin. The current database (2nd harvest) includes 5,051,467 patients whose laboratory samples were collected from October 1, 2015 and June 30, 2019. Only electronic data, and not blood samples, are sent to Hopkins. The academic investigators have unrestricted access to study data, take responsibility for the accuracy of analyses, and have authority over manuscript preparation and submission.

VARIABLES:

The variables currently in the VLDL database are testing date, age, sex, fasting/nonfasting, and components of the VAP test. From these primary variables, many additional variables were derived for inclusion in the master database. Other analytes measured by validated assays in subsets of the VLDL database include apolipoprotein B (apoB), apolipoprotein A1 (apoAI), high-sensitivity C-reactive protein (hsCRP), homocysteine, uric acid, insulin, hemoglobin A1c, 25-hydroxy vitamin D, cystatin C, lipoprotein-associated phosphatase (Lp-PLA2), thyroid stimulating hormone (TSH), free T3 and T4, pro-brain natriuretic peptide (pBNP), direct bilirubin, creatine phosphokinase (CPK), creatinine and other components of the comprehensive metabolic panel, magnesium, and phosphate.

研究设计

研究类型
Observational
观察模型
Other
时间视角
Cross Sectional

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

Low-density lipoprotein cholesterol level

时间窗: 4 years

Low-density lipoprotein cholesterol levels measured in milligrams per deciliter.

次要结局

未报告次要终点

研究者

申办方类型
Other
责任方
Sponsor

研究点 (1)

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