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

Atherosclerosis Clinical Trial

— ATERASurvey  

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT03799185
• Other study ID #: ID5726367
• Status: Completed
• Start date: January 4, 2016
• Est. completion date: August 31, 2019

Study information

• Verified date: January 2020
• Source: Association Tunisienne d'Etude & de Recherche sur l'Athérosclérose
• Contact: n/a
• Is FDA regulated: No
• Study type: Observational [Patient Registry]

Clinical Trial 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.

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)

Recruitment information / eligibility

• Status: Completed
• Enrollment: 13610
• Est. completion date: August 31, 2019
• Est. primary completion date: August 31, 2019
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: All
• Age group: 25 Years to 75 Years

Eligibility

Inclusion Criteria:

• All subjects

Exclusion Criteria:

• Prescribed treatment for cancer

• Organ transplantation

• Known auto-immune disease

• Severe liver disease

• Chronic renal failure

• Pregnant women

Related Conditions & MeSH terms

• Atherosclerosis
• Dyslipidemias
• Households
• Survey, Family Life

Locations

Country	Name	City	State
Tunisia	ATERA : Association Tunisienne d'Etude & de Recherche sur l'Athérosclérose	Tunis

Sponsors (9)

Lead Sponsor	Collaborator
Association Tunisienne d'Etude & de Recherche sur l'Athérosclérose	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

Country where clinical trial is conducted

Tunisia, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Other	Dietary assessment	Frequency of diet daily intake (fat, sugar, proteins, fiber)	Up to 1 month
Primary	Prevalence of dyslipidemia	Frequency of subjects with hypercholesterolemia and/or hypertriglyceridaemia	At inclusion
Secondary	Prevalence of cardiovascular associated risk factors	Frequency of subjects with cardiovascular risk factors (diabetes, hypertension, obesity, gender, smoking)	At inclusion

External Links

•   ATERA official Website
•   Prevalence of cardiovascular risk factors in the Tunisian population: The ATERA-survey