Atherosclerotic Cardiovascular DiseaseNCT03505073
Association Between Dietary Habits and Risk Factors for Atherosclerotic Cardiovascular Diseases in Assiut Governorate
An observational study of Atherosclerotic Cardiovascular Disease, run by Assiut University.
Trial summary
Studying and investigating the association between dietary habits and risk factors for atherosclerotic cardiovascular diseases in Assiut governorate Read more about this study
- Who is it for?
- Ages 18 years and olderHealthy volunteers can take part
- Conditions the study is for
- Atherosclerotic Cardiovascular Disease
- How many people
- 450 participants
- Where
- No sites listed yet
- Study dates
- May 2020to 31 Dec 2020
- How long will I take part?
- 10 Months
- 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 18 years and older
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Study population: All patients meeting the inclusion criteria attending on the outpatient clinics or admitted in Inpatients Ward or ICU of Assiut university Heart Hospital and Assiut Health Insurance Hospital during the study period.
- Inclusion criteria: Patients: male or female, aged ≥ 18 years and confirmed to have ASCVD, attending on the outpatient clinics or admitted in Inpatients Ward or ICU of Assiut university Heart Hospital and Assiut Health Insurance Hospital during the study period.
- Exclusion criteria: Patients: aged < 18 years and unconscious patients will be excluded from the study group.
About this study
Studying and investigating the association between dietary habits and risk factors for atherosclerotic cardiovascular diseases in Assiut governorate
Read the detailed description
Atherosclerotic cardiovascular diseases (ASCVD) has become the largest single cause of death worldwide. It is responsible for an estimated 17 million deaths and led to 151 million disability-adjusted life years (DALYs) lost (~30.0% of all deaths and 14.0% of all DALYs lost).1 Further, by 2020, 32.0% of the world population deaths will be caused by ASCVD and by 2030; it's expected to be responsible for 33.0% of all deaths (24.2 million).2 Most of atherosclerotic cardiovascular disease events nowadays are taking place in low- and middle-income countries with 80% of the burden occurring in these countries.3
In Egypt, since 1990, ASCVD related mortality was increased over three folds; to be responsible for over 40% of deaths compared with 12% reported two decades earlier.4 Egypt was categorized as a "very-high-risk country for ASCVD" (according to 2016 ESC Guidelines on cardiovascular disease prevention in clinical practice).5 According to (WHO 2014), ASCVD related mortality in Egypt has been increased to account for 46% of total deaths.
Multiple risk factors are attributed to causing ASCVD. These risk factors fall into the categories of either nonmodifiable or modifiable risk factors.6 Nonmodifiable risk factors consist of those conditions that a person cannot alter, including age, heredity, ethnicity and type 1 diabetes.
Whereas modifiable risk factors are conditions that can be altered by making certain lifestyle changes.
In 2003, the Canadian Heart and Stroke Foundation identified nine major modifiable risk factors for ASCVD, namely, tobacco smoking, alcohol abuse, physical inactivity, unhealthy dietary habits, obesity, high BP, high concentrations of dietary fat and blood lipids, and high blood glucose concentrations.7 Sudden stress, frequent migraine and the use of oral contraceptives have also been identified as risk factors for the increased incidence of coronary disease and stroke.8,9 The Egyptian National Hypertension Project (NHP)10,11 was conducted between year 1991 and 1993 in six Egyptian governorates to define the prevalence of ASCVD risk factors in adult Egyptians. The project documented an extremely high prevalence and prominent clustering of ASCVD risk factors in adult men and women particularly obesity.
Since that time, and despite the increasing ASCVD related morbidity and mortality in our Egyptian society, as mentioned before, there's no recent studies (up to our knowledge) was conducted to determine the risk factors associated to ASCVD.
This study overall aim is to systematically explore and investigate the association between dietary habits and risk factors for atherosclerotic cardiovascular diseases in Assiut governorate.
- Conditions
- Atherosclerotic Cardiovascular Disease
- Keywords
- ASCVD
- Medical subject headings
- Atherosclerosis
What is being measured
The primary outcome is the main question the study is designed to answer.
Detecting the association between dietary habits and risk factors for atherosclerotic cardiovascular diseases in Assiut governorate.
The study's overall aim is to systematically explore and investigate the association between dietary habits and risk factors for atherosclerotic cardiovascular diseases in Assiut governorate.
Measured: 10 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted23 Apr 2018
- Study startMay 2020 (estimated)
- Primary completion31 Dec 2020 (estimated)
- Study completion31 Dec 2020 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Atherosclerotic Cardiovascular DiseaseStudies of the same condition, open and under way.
- More trials run by Assiut UniversityThe sponsor's other registered studies.
- 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
- Cohort
- Time perspective
- Prospective
- Enrolment
- 450 participants (estimated)
- Target duration
- 10 Months
Sponsor and investigators
- Lead sponsor
- Assiut University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Eman Sabry, Assiut University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03505073
- Sponsor's protocol ID
- 10256
- Status last verified
- Mar 2020
- First submitted
- 13 Apr 2018
- Last updated
- 31 Mar 2020
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Undecided
Study at a glance
From the registry record, last updated by the sponsor on 31 Mar 2020. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Association Between Dietary Habits and Risk Factors for Atherosclerotic Cardiovascular Diseases in Assiut Governorate
- ClinicalTrials.gov ID
- NCT03505073
- Acronym / sponsor ID
- 10256
- Conditions
- Atherosclerotic Cardiovascular Disease
- Keywords
- ASCVD
- Study type
- Observational
- Recruitment status
- Unknown status
- Enrolment
- 450 participants (estimated)
- Lead sponsor
- Assiut UniversityUniversity, hospital or other
- Study start
- May 2020 (estimated)
- Primary completion
- 31 Dec 2020 (estimated)
- Study completion
- 31 Dec 2020 (estimated)
- First posted
- 23 Apr 2018 (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.
Studying and investigating the association between dietary habits and risk factors for atherosclerotic cardiovascular diseases in Assiut governorate
Detailed description
Atherosclerotic cardiovascular diseases (ASCVD) has become the largest single cause of death worldwide. It is responsible for an estimated 17 million deaths and led to 151 million disability-adjusted life years (DALYs) lost (~30.0% of all deaths and 14.0% of all DALYs lost).1 Further, by 2020, 32.0% of the world population deaths will be caused by ASCVD and by 2030; it's expected to be responsible for 33.0% of all deaths (24.2 million).2 Most of atherosclerotic cardiovascular disease events nowadays are taking place in low- and middle-income countries with 80% of the burden occurring in these countries.3
In Egypt, since 1990, ASCVD related mortality was increased over three folds; to be responsible for over 40% of deaths compared with 12% reported two decades earlier.4 Egypt was categorized as a "very-high-risk country for ASCVD" (according to 2016 ESC Guidelines on cardiovascular disease prevention in clinical practice).5 According to (WHO 2014), ASCVD related mortality in Egypt has been increased to account for 46% of total deaths.
Multiple risk factors are attributed to causing ASCVD. These risk factors fall into the categories of either nonmodifiable or modifiable risk factors.6 Nonmodifiable risk factors consist of those conditions that a person cannot alter, including age, heredity, ethnicity and type 1 diabetes.
Whereas modifiable risk factors are conditions that can be altered by making certain lifestyle changes.
In 2003, the Canadian Heart and Stroke Foundation identified nine major modifiable risk factors for ASCVD, namely, tobacco smoking, alcohol abuse, physical inactivity, unhealthy dietary habits, obesity, high BP, high concentrations of dietary fat and blood lipids, and high blood glucose concentrations.7 Sudden stress, frequent migraine and the use of oral contraceptives have also been identified as risk factors for the increased incidence of coronary disease and stroke.8,9 The Egyptian National Hypertension Project (NHP)10,11 was conducted between year 1991 and 1993 in six Egyptian governorates to define the prevalence of ASCVD risk factors in adult Egyptians. The project documented an extremely high prevalence and prominent clustering of ASCVD risk factors in adult men and women particularly obesity.
Since that time, and despite the increasing ASCVD related morbidity and mortality in our Egyptian society, as mentioned before, there's no recent studies (up to our knowledge) was conducted to determine the risk factors associated to ASCVD.
This study overall aim is to systematically explore and investigate the association between dietary habits and risk factors for atherosclerotic cardiovascular diseases in Assiut governorate.
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
- Target follow-up
- 10 Months
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
- Study population
- All patients meeting the inclusion criteria attending on the outpatient clinics or admitted in Inpatients Ward or ICU of Assiut university Heart Hospital and Assiut Health Insurance Hospital during the study period.
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
Detecting the association between dietary habits and risk factors for atherosclerotic cardiovascular diseases in Assiut governorate.
Time frame: 10 months
The study's overall aim is to systematically explore and investigate the association between dietary habits and risk factors for atherosclerotic cardiovascular diseases in Assiut governorate.
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 31 Mar 2020.
- Individual participant dataSharing planned: Undecided
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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.
The record lists no contact. Use the official record to reach the sponsor.
Questions about this trial
What is this clinical trial studying?
An observational study of Atherosclerotic Cardiovascular Disease, run by Assiut University.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
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: status not confirmed, as of the sponsor's last update on 31 Mar 2020. Status can change between updates, so confirm with the study contact before making plans.
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?
Results are not available in the source record.
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?
Detecting the association between dietary habits and risk factors for atherosclerotic cardiovascular diseases in Assiut governorate. (time frame: 10 months). 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 31 Mar 2020.