Official title: Prevalence of Cardiovascular Risk Factors in Patients Attending General Practice Clinics in Selected Countries in the Africa and The Middle East Region

This is a cross-sectional, epidemiological study to determine the prevalence of cardiovascular risk factors such as obesity, smoking, dyslipidemia, diabetes mellitus and hypertension in patients attending General Practice clinics in the Africa and Middle East region. A total of 4300 patients will be evaluated. In patients who are found to have previously been diagnosed with cardiovascular (CV) risk factors such as dyslipidemia or hypertension, the level of control of their respective conditions will also be evaluated.

Read the detailed description

This is a cross-sectional, epidemiological study. In the course of this study, 4,300 persons from general practice, and other non specialist clinics of selected countries of the Africa and Middle East region, will be evaluated for the presence of cardiovascular (CV) risk factors such as obesity, smoking, dyslipidaemia, diabetes mellitus and hypertension. The degree of control of hypertension and dyslipidaemia in those previously diagnosed with these conditions will also be assessed. All medications used for CV risk factor control will also be ascertained.

Patient evaluation will be done by physicians in charge of the selected clinics (who will be trained for case report forms completion) over one visit, through history taking, clinical examination as well as laboratory investigations. Every fifth patient seen on a particular day, fulfilling the inclusion and exclusion criteria would be included in the study.

Conditions: Obesity, Smoking, Dyslipidemia, Diabetes Mellitus, Hypertension
Keywords: Cross-sectional, epidemiological study, to evaluate the prevalence of CV risk factors in patients attending general practice in AfME region
Medical subject headings: Obesity, Smoking, Dyslipidemias, Diabetes Mellitus, Hypertension

What is being measured

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

Prevalence of cardiovascular (CV) risk factors such as obesity, smoking, dyslipidemia, diabetes mellitus and hypertension
Measured: At the time of the first visit

Secondary outcomes (5)

Compare the prevalence of cardiovascular (CV) risk factors such as obesity, smoking, dyslipidaemia, diabetes mellitus and hypertension in the urban and rural population.
Measured: At the time of the first visit
Compare the prevalence of CV risk factors such as obesity, smoking, dyslipidaemia, diabetes mellitus and hypertension in the male and female population.
Measured: At the time of the first visit
Stratifying the prevalence of CV risk factors such as obesity, smoking, dyslipidaemia, diabetes mellitus and hypertension by age groups.
Measured: At the time of the first visit
Ascertain the level of blood pressure and lipids' control as per the European Society of Cardiology (ESC) guidelines in patients who have been previously diagnosed as hypertensive or dyslipidaemic.
Measured: At the time of the first visit
Ascertain the most commonly used medications in those that have been previously diagnosed as diabetic, hypertensive or dyslipidaemic.
Measured: At the time of the first visit

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

Jul 2011Apr 2012

First posted18 Nov 2010 (estimated)
Study startJul 2011
Primary completionApr 2012
Study completionApr 2012

Resources

Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
Publications (4)Papers the sponsor has linked to this study.
Other trials for ObesityStudies 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: Other
Time perspective: Cross-sectional
Enrolment: 4,386 participants (actual)

IDs, dates and publications

ClinicalTrials.gov ID: NCT01243138
Sponsor's protocol ID: A2581186
Acronym: ACE
Status last verified: Feb 2021
First submitted: 12 Nov 2010
Last updated: 18 Feb 2021
Results posted: No
Data monitoring committee: No

Publications

Hamoui O, Omar MI, Raal FJ, Rashed W, Kane A, Alami M, Abreu P, Mashhoud W, Alsheikh-Ali AA. Increases in statin eligibility to reduce cardiovascular risk according to the 2013 ACC/AHA cholesterol guidelines in the Africa Middle East region: a sub-analysis of the Africa Middle East Cardiovascular Epidemiological (ACE) study. BMC Cardiovasc Disord. 2019 Mar 15;19(1):61. doi: 10.1186/s12872-019-1034-2.
PubMed 30876390
Brouri M, Ouadahi N, Nibouche D, Benabbas Y, El Hassar M, Bouraoui S, Abad N, Abreu PC, Ikardouchene L. [Cardiovascular risk factors in Algeria. Analysis of the subgroup from the "Africa/Middle East Cardiovascular Epidemiological" Study]. Ann Cardiol Angeiol (Paris). 2018 Apr;67(2):61-66. doi: 10.1016/j.ancard.2018.01.003. Epub 2018 Mar 9. French.
PubMed 29530274
Raal FJ, Alsheikh-Ali AA, Omar MI, Rashed W, Hamoui O, Kane A, Alami M, Abreu P, Mashhoud WM. Cardiovascular risk factor burden in Africa and the Middle East across country income categories: a post hoc analysis of the cross-sectional Africa Middle East Cardiovascular Epidemiological (ACE) study. Arch Public Health. 2018 Feb 12;76:15. doi: 10.1186/s13690-018-0257-5. eCollection 2018.
PubMed 29449941
Ahmed AM, Hersi A, Mashhoud W, Arafah MR, Abreu PC, Al Rowaily MA, Al-Mallah MH. Cardiovascular risk factors burden in Saudi Arabia: The Africa Middle East Cardiovascular Epidemiological (ACE) study. J Saudi Heart Assoc. 2017 Oct;29(4):235-243. doi: 10.1016/j.jsha.2017.03.004. Epub 2017 Mar 14.
PubMed 28983166

Want to know more?

The sponsor has not listed a contact. The official record may have more details.

Talk to your doctor first and take this page with you. Only the study team can confirm whether you can join.

Questions to ask the study team

What is the study trying to find out?
What would I need to do, and how often would I visit?
Could I receive a placebo instead of the treatment?
What are the possible risks and benefits for me?
Will it cost me anything? Are travel or time paid for?
Can I keep seeing my own doctor during the study?
What happens when the study ends?

See locations

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Study at a glance

From the registry record, last updated by the sponsor on 18 Feb 2021. Recruitment status is as the sponsor reported it: confirm with the study team.

Official title: Prevalence of Cardiovascular Risk Factors in Patients Attending General Practice Clinics in Selected Countries in the Africa and The Middle East Region
ClinicalTrials.gov ID: NCT01243138
Acronym / sponsor ID: ACE / A2581186
Conditions: Obesity, Smoking, Dyslipidemia, Diabetes Mellitus, Hypertension
Keywords: Cross-sectional, epidemiological study, to evaluate the prevalence of CV risk factors in patients attending general practice in AfME region
Study type: Observational
Recruitment status: Completed
Enrolment: 4,386 participants (actual)
Lead sponsor: Pfizer's Upjohn has merged with Mylan to form Viatris Inc.Industry (pharma, biotech, devices)
Study start: Jul 2011
Primary completion: Apr 2012 (actual)
Study completion: Apr 2012 (actual)
First posted: 18 Nov 2010 (estimated)
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.

Detailed description

Study design

Observational model: Other
Time perspective: Cross-sectional

Who may qualify

Ages: 18 years and older
Sex: All
Healthy volunteers: Accepted
Age groups: Adult, Older adult
Study population: Subject selection would be from clinics in a primary care setting

Key inclusion criteria (1 listed)

Adult aged 18 or above

Key exclusion criteria (2 listed)

Pregnant women and/or lactating mothers
Subjects presenting with any life threatening disease/condition

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 cardiovascular (CV) risk factors such as obesity, smoking, dyslipidemia, diabetes mellitus and hypertension
Time frame: At the time of the first visit

5 secondary outcomes

Compare the prevalence of cardiovascular (CV) risk factors such as obesity, smoking, dyslipidaemia, diabetes mellitus and hypertension in the urban and rural population.
Time frame: At the time of the first visit
Compare the prevalence of CV risk factors such as obesity, smoking, dyslipidaemia, diabetes mellitus and hypertension in the male and female population.
Time frame: At the time of the first visit
Stratifying the prevalence of CV risk factors such as obesity, smoking, dyslipidaemia, diabetes mellitus and hypertension by age groups.
Time frame: At the time of the first visit
Ascertain the level of blood pressure and lipids' control as per the European Society of Cardiology (ESC) guidelines in patients who have been previously diagnosed as hypertensive or dyslipidaemic.
Time frame: At the time of the first visit
Ascertain the most commonly used medications in those that have been previously diagnosed as diabetic, hypertensive or dyslipidaemic.
Time frame: At the time of the first visit

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 18 Feb 2021.
Derived from this study: PubMed 30876390Hamoui O, Omar MI, Raal FJ, Rashed W, Kane A, Alami M, Abreu P, Mashhoud W, Alsheikh-Ali AA. Increases in statin eligibility to reduce cardiovascular risk according to the 2013 ACC/AHA cholesterol guidelines in the Africa Middle East region: a sub-analysis of the Africa Middle East Cardiovascular Epidemiological (ACE) study. BMC Cardiovasc Disord. 2019 Mar 15;19(1):61. doi: 10.1186/s12872-019-1034-2.
Derived from this study: PubMed 29530274Brouri M, Ouadahi N, Nibouche D, Benabbas Y, El Hassar M, Bouraoui S, Abad N, Abreu PC, Ikardouchene L. [Cardiovascular risk factors in Algeria. Analysis of the subgroup from the "Africa/Middle East Cardiovascular Epidemiological" Study]. Ann Cardiol Angeiol (Paris). 2018 Apr;67(2):61-66. doi: 10.1016/j.ancard.2018.01.003. Epub 2018 Mar 9. French.
Derived from this study: PubMed 29449941Raal FJ, Alsheikh-Ali AA, Omar MI, Rashed W, Hamoui O, Kane A, Alami M, Abreu P, Mashhoud WM. Cardiovascular risk factor burden in Africa and the Middle East across country income categories: a post hoc analysis of the cross-sectional Africa Middle East Cardiovascular Epidemiological (ACE) study. Arch Public Health. 2018 Feb 12;76:15. doi: 10.1186/s13690-018-0257-5. eCollection 2018.
Derived from this study: PubMed 28983166Ahmed AM, Hersi A, Mashhoud W, Arafah MR, Abreu PC, Al Rowaily MA, Al-Mallah MH. Cardiovascular risk factors burden in Saudi Arabia: The Africa Middle East Cardiovascular Epidemiological (ACE) study. J Saudi Heart Assoc. 2017 Oct;29(4):235-243. doi: 10.1016/j.jsha.2017.03.004. Epub 2017 Mar 14.
To obtain contact information for a study center near you, click here.Link provided by the sponsor.

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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.

Pfizer CT.gov Call Center study director

Pfizer

73 sites in 14 countries: see every site and its status.

Questions about this trial

What is this clinical trial studying?

An observational study of Obesity and Smoking, run by Pfizer's Upjohn has merged with Mylan to form Viatris Inc. at 73 sites in 14 countries.

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 2 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 18 Feb 2021. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 73 sites in Algeria, South Africa, Cameroon, Kuwait, Saudi Arabia and 9 more countries. 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 cardiovascular (CV) risk factors such as obesity, smoking, dyslipidemia, diabetes mellitus and hypertension (time frame: At the time of the first visit). It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT01243138, which also lists 4 linked publications.

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 18 Feb 2021.