Clinical trial NCT03799185: Dyslipidemia Prevalence, Perception, Treatment, and Awareness in the Tunisian Population
Official title: Dyslipidemia Prevalence, Perception, Treatment, and Awareness in the Tunisian Population : The ATERA Survey
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Dyslipidemias
Atherosclerosis
Households
Survey, Family Life
Keywords: Coronary Heart Disease
Hypercholesterolemia
Triglycerides High
LDL Hyperlipoproteinemia
HDL Low
Diabetes
Cardiovascular Diseases
Hypertension
Risk Factor, Cardiovascular
Diet Habit
Smoking
Lead sponsor: Association Tunisienne d'Etude & de Recherche sur l'Athérosclérose
Sponsor class: OTHER
Collaborators: name: Biochimie Clinique LR99ES11
name: Department of Biochemistry, La Rabta Hospital, Tunisia.
name: Ministry of Health, Tunisia
name: Ministry of Interior, Tunisia
name: Direction des Soins de Santé de Base
name: National Institute of Statistics
name: National Institute of Public Health of Tunisia
name: Dacima Consulting
First posted: 2019-01-10
Enrollment: 13610
Sex: ALL
Minimum age (years): 25
Maximum age (years): 75
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Observational model: FAMILY_BASED
Time perspective: CROSS_SECTIONAL
Sampling method: PROBABILITY_SAMPLE
Study population: All subjects aged between 25 and 75 years who accept to participate at the study

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)

Eligibility criteria: Inclusion Criteria:

* All subjects

Exclusion Criteria:

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

Primary outcomes:
measure: Prevalence of dyslipidemia
timeFrame: At inclusion
Secondary outcomes:
measure: Prevalence of cardiovascular associated risk factors
timeFrame: At inclusion
Other outcomes:
measure: Dietary assessment
timeFrame: Up to 1 month
Locations:
city: Tunis
country: Tunisia
facility: ATERA : Association Tunisienne d'Etude & de Recherche sur l'Athérosclérose
Study officials:
affiliation: Association Tunisienne d'Etude & de Recherche sur l'Athérosclérose
name: Amani Kallel, PhD
role: STUDY_CHAIR
affiliation: Association Tunisienne d'Etude & de Recherche sur l'Athérosclérose
name: Riadh Jemaa, PhD
role: STUDY_CHAIR
References: