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

NCT ID: NCT03799185

Last Updated: 2020-01-22

Basic Information

• Recruitment Status: COMPLETED
• Total Enrollment: 13610 participants
• Study Classification: OBSERVATIONAL
• Study Start Date: 2016-01-04
• Study Completion Date: 2019-08-31

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)

Conditions

Dyslipidemias; Atherosclerosis; Households; Survey, Family Life

Study Design

• Observational Model Type: FAMILY_BASED
• Study Time Perspective: CROSS_SECTIONAL

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

• Minimum Eligible Age: 25 Years
• Maximum Eligible Age: 75 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: Yes

Sponsors

Biochimie Clinique LR99ES11

UNKNOWN

Sponsor Role: collaborator

Department of Biochemistry, La Rabta Hospital, Tunisia.

UNKNOWN

Sponsor Role: collaborator

Ministry of Health, Tunisia

UNKNOWN

Sponsor Role: collaborator

Ministry of Interior, Tunisia

UNKNOWN

Sponsor Role: collaborator

Direction des Soins de Santé de Base

OTHER_GOV

Sponsor Role: collaborator

National Institute of Statistics

UNKNOWN

Sponsor Role: collaborator

National Institute of Public Health of Tunisia

UNKNOWN

Sponsor Role: collaborator

Dacima Consulting

OTHER

Sponsor Role: collaborator

Association Tunisienne d'Etude & de Recherche sur l'Athérosclérose

OTHER

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Principal Investigators

Amani Kallel, PhD

Role: STUDY_CHAIR

Association Tunisienne d'Etude & de Recherche sur l'Athérosclérose

Riadh Jemaa, PhD

Role: STUDY_CHAIR

Association Tunisienne d'Etude & de Recherche sur l'Athérosclérose

Locations

ATERA : Association Tunisienne d'Etude & de Recherche sur l'Athérosclérose

Tunis, , Tunisia

Countries

Tunisia

Other Identifiers

ID5726367

Identifier Type: -

Identifier Source: org_study_id