Dyslipidemia Prevalence, Perception, Treatment, and Awareness in the Tunisian Population (ATERASurvey)

January 17, 2020 updated by: Association Tunisienne d'Etude & de Recherche sur l'Athérosclérose

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.

Study Overview

Status

Completed

Conditions

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)

Study Type

Observational

Enrollment (Actual)

13610

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • Tunisia
      • Tunis, Tunisia, 1007
        • ATERA : Association Tunisienne d'Etude & de Recherche sur l'Athérosclérose

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

25 years to 75 years (Adult, Older Adult)

Accepts Healthy Volunteers

Yes

Genders Eligible for Study

All

Sampling Method

Probability Sample

Study Population

All subjects aged between 25 and 75 years who accept to participate at the study

Description

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 Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Prevalence of dyslipidemia
Time Frame: At inclusion
Frequency of subjects with hypercholesterolemia and/or hypertriglyceridaemia
At inclusion

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Prevalence of cardiovascular associated risk factors
Time Frame: At inclusion
Frequency of subjects with cardiovascular risk factors (diabetes, hypertension, obesity, gender, smoking)
At inclusion

Other Outcome Measures

Outcome Measure
Measure Description
Time Frame
Dietary assessment
Time Frame: Up to 1 month
Frequency of diet daily intake (fat, sugar, proteins, fiber)
Up to 1 month

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

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

Collaborators

Dacima Consulting
Direction des Soins de Santé de Base
Biochimie Clinique LR99ES11
Department of Biochemistry, La Rabta Hospital, Tunisia.
Ministry of Health, Tunisia
Ministry of Interior, Tunisia
National Institute of Statistics
National Institute of Public Health of Tunisia

Investigators

  • 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

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

Helpful Links

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

January 4, 2016

Primary Completion (Actual)

August 31, 2019

Study Completion (Actual)

August 31, 2019

Study Registration Dates

First Submitted

January 8, 2019

First Submitted That Met QC Criteria

January 8, 2019

First Posted (Actual)

January 10, 2019

Study Record Updates

Last Update Posted (Actual)

January 22, 2020

Last Update Submitted That Met QC Criteria

January 17, 2020

Last Verified

January 1, 2020

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • ID5726367

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

UNDECIDED

IPD Plan Description

CSR (Clinical Study Report)

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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