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临床试验/NCT03799185
NCT03799185已完成不适用

Dyslipidemia Prevalence, Perception, Treatment, and Awareness in the Tunisian Population : The ATERA Survey

Association Tunisienne d'Etude & de Recherche sur l'Athérosclérose1 个研究点 分布在 1 个国家目标入组 13,610 人开始时间: 2016年1月4日最近更新:
适应症

试验速览

阶段
不适用
状态
已完成
发起方
入组人数
13,610
试验地点
1
主要终点
Prevalence of dyslipidemia

研究概览

简要总结

ATERA Survey is a national cross sectional observational study, aiming to determine the prevalence of dyslipidemia and other conventional risk factors for CHD (Coronary Heart Disease), the relationship between environmental and lifestyle factors with dyslipidemia, the perception and the knowledge of cardiovascular risk factors by the population, and above all, to strengthen the national strategy for primary and secondary prevention against coronary heart disease.

详细描述

ATERA Survey is carried on in a random sampling including 10 000 men and women from the seven regions of Tunisia (Great Tunis, North East, North West, central East, Central West, South East and South West. The screening is being assessed using surveys covering socioeconomic, nutritional and anthropometric measures in addition to biological assessments.

The target population is being recruited by random sampling drown by the National Institute of Statistics (Tunisia). The estimated number of participants at the end of recruitment amount to 10 000. The frame sampling uses a two stage cluster sampling (district and household).

Interview with each eligible participant will be conducted mainly during assessment visit and after consenting the subject, it will be notified all the demographic, behavioral history, family history, cardiovascular risk factors and medical history. During the assessment visit, Physical examination/anthropometry data and Diet survey will be filled up by the investigator.

Data capture will be performed by the DACIMA Clinical Suite according to FDA 21 CFR part 11 requirements (Food and Drug Administration 21 Code of Federal Regulations part 11), the HIPAA specifications (Health Insurance Portability and Accountability Act), and the ICH standards (International Conference on Harmonisation)

研究设计

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

入排标准

年龄范围
25 Years 至 75 Years(Adult, Older Adult)
性别
All
接受健康志愿者

入选标准

  • All subjects

排除标准

  • Prescribed treatment for cancer
  • Organ transplantation
  • Known auto-immune disease
  • Severe liver disease
  • Chronic renal failure
  • Pregnant women

结局指标

主要结局

Prevalence of dyslipidemia

时间窗: At inclusion

Frequency of subjects with hypercholesterolemia and/or hypertriglyceridaemia

次要结局

  • Prevalence of cardiovascular associated risk factors(At inclusion)

研究者

发起方
Association Tunisienne d'Etude & de Recherche sur l'Athérosclérose
申办方类型
Other
责任方
Sponsor

研究点 (1)

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