Dyslipidemia Prevalence, Perception, Treatment, and Awareness in the Tunisian Population (ATERASurvey)
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|ClinicalTrials.gov Identifier: NCT03799185|
Recruitment Status : Recruiting
First Posted : January 10, 2019
Last Update Posted : January 14, 2019
|Condition or disease|
|Dyslipidemias Atherosclerosis Households Survey, Family Life|
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 Type :||Observational [Patient Registry]|
|Estimated Enrollment :||12000 participants|
|Target Follow-Up Duration:||1 Day|
|Official Title:||Dyslipidemia Prevalence, Perception, Treatment, and Awareness in the Tunisian Population : The ATERA Survey|
|Actual Study Start Date :||January 4, 2016|
|Estimated Primary Completion Date :||February 28, 2019|
|Estimated Study Completion Date :||February 28, 2019|
- Prevalence of dyslipidemia [ Time Frame: At inclusion ]Frequency of subjects with hypercholesterolemia and/or hypertriglyceridaemia
- Prevalence of cardiovascular associated risk factors [ Time Frame: At inclusion ]Frequency of subjects with cardiovascular risk factors (diabetes, hypertension, obesity, gender, smoking)
- Dietary assessment [ Time Frame: Up to 1 month ]Frequency of diet daily intake (fat, sugar, proteins, fiber)
Biospecimen Retention: Samples Without DNA
To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03799185
|Contact: Amani Kallel, PhDfirstname.lastname@example.org|
|Contact: Riadh Jemaa, PhDemail@example.com|
|ATERA : Association Tunisienne d'Etude & de Recherche sur l'Athérosclérose||Recruiting|
|Tunis, Tunisia, 1007|
|Contact: Amani Kallel, PhD +21696872787 firstname.lastname@example.org|
|Contact: Riadh Jemaa, PhD +21698819168 email@example.com|
|Study Chair:||Amani Kallel, PhD||Association Tunisienne d'Etude & de Recherche sur l'Athérosclérose|
|Study Chair:||Riadh Jemaa, PhD||Association Tunisienne d'Etude & de Recherche sur l'Athérosclérose|