Atherosclerosis Clinical Trial
Official title:
Dyslipidemia Prevalence, Perception, Treatment, and Awareness in the Tunisian Population : The ATERA Survey
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.
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)
;
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