Working…
ClinicalTrials.gov
ClinicalTrials.gov Menu

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

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Know the risks and potential benefits of clinical studies and talk to your health care provider before participating. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT03799185
Recruitment Status : Recruiting
First Posted : January 10, 2019
Last Update Posted : January 14, 2019
Sponsor:
Collaborators:
Biochimie Clinique LR99ES11
Department of Biochemistry, La Rabta Hospital, Tunisia.
Ministry of Health, Tunisia
Ministry of Interior, Tunisia
Direction des Soins de Santé de Base
National Institute of Statistics
National Institute of Public Health of Tunisia
Dacima Consulting
Information provided by (Responsible Party):
Association Tunisienne d'Etude & de Recherche sur l'Athérosclérose

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.

Condition or disease
Dyslipidemias Atherosclerosis Households Survey, Family Life

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)


Layout table for study information
Study Type : Observational [Patient Registry]
Estimated Enrollment : 12000 participants
Observational Model: Family-Based
Time Perspective: Cross-Sectional
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



Primary Outcome Measures :
  1. Prevalence of dyslipidemia [ Time Frame: At inclusion ]
    Frequency of subjects with hypercholesterolemia and/or hypertriglyceridaemia


Secondary Outcome Measures :
  1. Prevalence of cardiovascular associated risk factors [ Time Frame: At inclusion ]
    Frequency of subjects with cardiovascular risk factors (diabetes, hypertension, obesity, gender, smoking)


Other Outcome Measures:
  1. Dietary assessment [ Time Frame: Up to 1 month ]
    Frequency of diet daily intake (fat, sugar, proteins, fiber)


Biospecimen Retention:   Samples Without DNA
Serum


Information from the National Library of Medicine

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.


Layout table for eligibility information
Ages Eligible for Study:   25 Years to 75 Years   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   Yes
Sampling Method:   Probability Sample
Study Population
All subjects aged between 25 and 75 years who accept to participate at the study
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

Information from the National Library of Medicine

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


Contacts
Layout table for location contacts
Contact: Amani Kallel, PhD +21696872787 kalamany2@gmail.com
Contact: Riadh Jemaa, PhD +21698819168 jemaa_riadh@yahoo.fr

Locations
Layout table for location information
Tunisia
ATERA : Association Tunisienne d'Etude & de Recherche sur l'Athérosclérose Recruiting
Tunis, Tunisia, 1007
Contact: Amani Kallel, PhD    +21696872787    kalamany2@gmail.com   
Contact: Riadh Jemaa, PhD    +21698819168    jemaa_riadh@yahoo.fr   
Sponsors and Collaborators
Association Tunisienne d'Etude & de Recherche sur l'Athérosclérose
Biochimie Clinique LR99ES11
Department of Biochemistry, La Rabta Hospital, Tunisia.
Ministry of Health, Tunisia
Ministry of Interior, Tunisia
Direction des Soins de Santé de Base
National Institute of Statistics
National Institute of Public Health of Tunisia
Dacima Consulting
Investigators
Layout table for investigator information
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

Additional Information:
Layout table for additonal information
Responsible Party: Association Tunisienne d'Etude & de Recherche sur l'Athérosclérose
ClinicalTrials.gov Identifier: NCT03799185     History of Changes
Other Study ID Numbers: ID5726367
First Posted: January 10, 2019    Key Record Dates
Last Update Posted: January 14, 2019
Last Verified: January 2019
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: Undecided
Plan Description: CSR (Clinical Study Report)

Layout table for additional information
Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
Keywords provided by Association Tunisienne d'Etude & de Recherche sur l'Athérosclérose:
Hypercholesterolemia
Coronary Heart Disease
Triglycerides High
LDL Hyperlipoproteinemia
HDL Low
Diabetes
Cardiovascular Diseases
Hypertension
Risk Factor, Cardiovascular
Diet Habit
Smoking
Additional relevant MeSH terms:
Layout table for MeSH terms
Atherosclerosis
Dyslipidemias
Arteriosclerosis
Arterial Occlusive Diseases
Vascular Diseases
Cardiovascular Diseases
Lipid Metabolism Disorders
Metabolic Diseases