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

Completed

• Conditions: Households; Survey, Family Life; Atherosclerosis; Dyslipidemias

• Registration Number: NCT03799185
• Lead Sponsor: Association Tunisienne d'Etude & de Recherche sur l'Athérosclérose

Brief Summary

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.

Detailed Description

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)

Study Timeline

• Study Start: 2016-01-04
• Study First Submitted: 2019-01-08
• Study First Submitted QC: 2019-01-08
• Study First Posted: 2019-01-10
• Primary Completion: 2019-08-31
• Study Completion: 2019-08-31
• Status Verified: 2020-01
• Last Update Submitted: 2020-01-17
• Last Update Posted: 2020-01-22

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 13610

Inclusion Criteria

• All subjects

Exclusion Criteria

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

Study & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
Prevalence of dyslipidemia	At inclusion	Frequency of subjects with hypercholesterolemia and/or hypertriglyceridaemia

Secondary Outcome Measures

Name	Time	Method
Prevalence of cardiovascular associated risk factors	At inclusion	Frequency of subjects with cardiovascular risk factors (diabetes, hypertension, obesity, gender, smoking)

Trial Locations

Locations (1)

ATERA : Association Tunisienne d'Etude & de Recherche sur l'Athérosclérose; 🇹🇳 Tunis, Tunisia