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Completed

NCT Number: NCT03799185

Dyslipidemia Prevalence, Perception, Treatment, and Awareness in the Tunisian Population

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.

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Key information

About this study

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)

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

  • All subjects

Exclusion criteria

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

Treatment and study plan

Primary outcomes

  1. Prevalence of dyslipidemia

    Time frame: At inclusion

    Frequency of subjects with hypercholesterolemia and/or hypertriglyceridaemia

Secondary outcomes

  1. Prevalence of cardiovascular associated risk factors

    Time frame: At inclusion

    Frequency of subjects with cardiovascular risk factors (diabetes, hypertension, obesity, gender, smoking)

Other outcomes

  1. Dietary assessment

    Time frame: Up to 1 month

    Frequency of diet daily intake (fat, sugar, proteins, fiber)

Sponsors and collaborators

Lead sponsor

Association Tunisienne d'Etude & de Recherche sur l'Athérosclérose

Other

Collaborators

  • Biochimie Clinique LR99ES11
  • Dacima Consulting
  • Department of Biochemistry, La Rabta Hospital, Tunisia.
  • Direction des Soins de Santé de Base
  • Ministry of Health, Tunisia
  • Ministry of Interior, Tunisia
  • National Institute of Public Health of Tunisia
  • National Institute of Statistics

Registry information

Official study title

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

Acronym: ATERASurvey

Important dates

Study start
2016
Primary completion
2019
Study completion
2019
First posted
Jan 10, 2019
Registry last updated
Jan 22, 2020

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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