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NCT03799185 Clinical Trial

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
Secondary ID
Status Completed
Phase
First received
Last updated
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
Health authority
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

Study Design

Related Conditions & MeSH terms

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
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