AzTrials
AzTrials

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.

Unknown status

Status not confirmed. The sponsor has not verified this record for over two years, so it may be out of date.

Official record
Search all trials

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.

Keywords
ASCVD
Medical subject headings
Atherosclerosis

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. 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.

  1. First posted23 Apr 2018
  2. Study startMay 2020 (estimated)
  3. Primary completion31 Dec 2020 (estimated)
  4. Study completion31 Dec 2020 (estimated)

Resources

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
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

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.

Free account

Log in to keep searching

You’ve used your 3 free searches. AzTrials is free: log in or create a free account to keep searching clinical trials and save the ones you want to follow.

Create a free accountLog in