DyslipidemiasATERASurveyNCT03799185
Dyslipidemia Prevalence, Perception, Treatment, and Awareness in the Tunisian Population
An observational study of Dyslipidemias and Atherosclerosis, run by Association Tunisienne d'Etude & de Recherche sur l'Athérosclérose at 1 site in Tunisia.
Trial 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… Read more about this study
- Who is it for?
- Ages 25 to 75 yearsHealthy volunteers can take part
- Conditions the study is for
- Dyslipidemias, Atherosclerosis, Households
- How many people
- 13,610 participants
- Where
- 1 siteTunisia
- Study dates
- 4 Jan 2016to 31 Aug 2019
- How long will I take part?
- 1 Day
- Phase
- Observational
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 25 to 75 years
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Study population: All subjects aged between 25 and 75 years who accept to participate at the study
Who may be able to join
- All subjects
Who cannot join
- Prescribed treatment for cancer
- Organ transplantation
- Known auto-immune disease
- Severe liver disease
- Chronic renal failure
- Pregnant women
Trial locations and contacts
1 site in 1 country.
Tunisia1 site
ATERA : Association Tunisienne d'Etude & de Recherche sur l'Athérosclérose
Tunis, 1007
About this study
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.
Read the 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
- Keywords
- Coronary Heart Disease, Hypercholesterolemia, Triglycerides High, LDL Hyperlipoproteinemia, HDL Low, Diabetes, Cardiovascular Diseases, Hypertension, Risk Factor, Cardiovascular, Diet Habit, Smoking
- Medical subject headings
- Dyslipidemias, Atherosclerosis, Coronary Disease, Hypercholesterolemia, Hypertriglyceridemia, Diabetes Mellitus, Cardiovascular Diseases, Hypertension
What is being measured
The primary outcome is the main question the study is designed to answer.
Prevalence of dyslipidemia
Frequency of subjects with hypercholesterolemia and/or hypertriglyceridaemia
Measured: At inclusion
Secondary outcomes (1)
Prevalence of cardiovascular associated risk factors
Frequency of subjects with cardiovascular risk factors (diabetes, hypertension, obesity, gender, smoking)
Measured: At inclusion
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted10 Jan 2019
- Study start4 Jan 2016
- Primary completion31 Aug 2019
- Study completion31 Aug 2019
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for DyslipidemiasStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Family based
- Time perspective
- Cross-sectional
- Enrolment
- 13,610 participants (actual)
- Target duration
- 1 Day
Sponsor and investigators
- Lead sponsor
- Association Tunisienne d'Etude & de Recherche sur l'Athérosclérose
- Sponsor type
- University, hospital or other
- 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
- Responsible party
- Sponsor
- Investigators
- Amani Kallel, PhD, Study chair, Association Tunisienne d'Etude & de Recherche sur l'AthéroscléroseRiadh Jemaa, PhD, Study chair, Association Tunisienne d'Etude & de Recherche sur l'Athérosclérose
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03799185
- Sponsor's protocol ID
- ID5726367
- Acronym
- ATERASurvey
- Status last verified
- Jan 2020
- First submitted
- 8 Jan 2019
- Last updated
- 22 Jan 2020
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Undecided: CSR (Clinical Study Report)
Study at a glance
From the registry record, last updated by the sponsor on 22 Jan 2020. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Dyslipidemia Prevalence, Perception, Treatment, and Awareness in the Tunisian Population : The ATERA Survey
- ClinicalTrials.gov ID
- NCT03799185
- Acronym / sponsor ID
- ATERASurvey / ID5726367
- Conditions
- Dyslipidemias, Atherosclerosis, Households, Survey, Family Life
- Keywords
- Coronary Heart Disease, Hypercholesterolemia, Triglycerides High, LDL Hyperlipoproteinemia, HDL Low, Diabetes, Cardiovascular Diseases, Hypertension
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 13,610 participants (actual)
- Lead sponsor
- Association Tunisienne d'Etude & de Recherche sur l'AthéroscléroseUniversity, hospital or other
- 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
- Study start
- 4 Jan 2016 (actual)
- Primary completion
- 31 Aug 2019 (actual)
- Study completion
- 31 Aug 2019 (actual)
- First posted
- 10 Jan 2019 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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)
Study design
- Observational model
- Family based
- Time perspective
- Cross-sectional
- Target follow-up
- 1 Day
Who may qualify
- Ages
- 25 to 75 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
- Study population
- All subjects aged between 25 and 75 years who accept to participate at the study
Key inclusion criteria (1 listed)
- All subjects
Key exclusion criteria (6 listed)
- Prescribed treatment for cancer
- Organ transplantation
- Known auto-immune disease
- Severe liver disease
- Chronic renal failure
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Primary outcome
Prevalence of dyslipidemia
Time frame: At inclusion
Frequency of subjects with hypercholesterolemia and/or hypertriglyceridaemia
1 secondary outcome
Prevalence of cardiovascular associated risk factors
Time frame: At inclusion
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 22 Jan 2020.
- Prevalence of cardiovascular risk factors in the Tunisian population: The ATERA-surveyLink provided by the sponsor.
- Individual participant dataSharing planned: Undecided. CSR (Clinical Study Report)
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Amani Kallel, PhD study chair
Association Tunisienne d'Etude & de Recherche sur l'Athérosclérose
Riadh Jemaa, PhD study chair
Association Tunisienne d'Etude & de Recherche sur l'Athérosclérose
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Dyslipidemias and Atherosclerosis, run by Association Tunisienne d'Etude & de Recherche sur l'Athérosclérose at 1 site in Tunisia.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 1 inclusion and 6 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 22 Jan 2020. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Tunisia. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Prevalence of dyslipidemia (time frame: At inclusion). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 22 Jan 2020.