NCT01243138

Brief Summary

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.

Trial Health

98
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
4,386

participants targeted

Target at P75+ for all trials

Timeline
Completed

Started Jul 2011

Shorter than P25 for all trials

Geographic Reach
14 countries

73 active sites

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

November 12, 2010

Completed
6 days until next milestone

First Posted

Study publicly available on registry

November 18, 2010

Completed
8 months until next milestone

Study Start

First participant enrolled

July 1, 2011

Completed
9 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

April 1, 2012

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

April 1, 2012

Completed
Last Updated

February 18, 2021

Status Verified

February 1, 2021

Enrollment Period

9 months

First QC Date

November 12, 2010

Last Update Submit

February 17, 2021

Conditions

Keywords

Cross-sectionalepidemiological studyto evaluate the prevalence of CV risk factors in patients attending general practice in AfME region

Outcome Measures

Primary Outcomes (1)

  • Prevalence of cardiovascular (CV) risk factors such as obesity, smoking, dyslipidemia, diabetes mellitus and hypertension

    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.

    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.

    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.

    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.

    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.

    At the time of the first visit

Eligibility Criteria

Age18 Years+
Sexall
Healthy VolunteersYes
Age GroupsAdult (18-64), Older Adult (65+)
Sampling MethodProbability Sample
Study Population

Subject selection would be from clinics in a primary care setting

You may qualify if:

  • Adult aged 18 or above

You may not qualify if:

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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (73)

Pfizer Investigational Site

Algiers, 16015, Algeria

Location

Pfizer Investigational Site

Bejaja, 6000, Algeria

Location

Pfizer Investigational Site

Djelfa, 17000, Algeria

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Pfizer Investigational Site

Laghouat, Algeria

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Pfizer Investigational Site

M'Sila, Algeria

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Pfizer Investigational Site

Relizane, 48000, Algeria

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Pfizer Investigational Site

Saïda, 20000, Algeria

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Pfizer Investigational Site

Tébessa, Algeria

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Pfizer Investigational Site

Tlemcen, 13000, Algeria

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Pfizer Investigational Site

Yaoundé, Cite Verte, Cameroon

Location

Pfizer Investigational Site

Douala, Deido, Cameroon

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Pfizer Investigational Site

Bafoussam, Cameroon

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Pfizer Investigational Site

Mbandjok, Cameroon

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Pfizer Investigational Site

Njombé, Cameroon

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Pfizer Investigational Site

Okoa, Cameroon

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Pfizer Investigational Site

Alexandria, Egypt

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Pfizer Investigational Site

Cairo, Egypt

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Pfizer Investigational Site

Shiben Al Kom, Egypt

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Pfizer Investigational Site

Tanta, Egypt

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Pfizer Investigational Site

Accra, Ghana

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Pfizer Investigational Site

Jachie-Ashanti, Ghana

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Pfizer Investigational Site

Kumasi, Ghana

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Pfizer Investigational Site

Sogakope V/R, Ghana

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Pfizer Investigational Site

Takoradze, Ghana

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Pfizer Investigational Site

Amman, Jordan

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Pfizer Investigational Site

Irbid, Jordan

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Pfizer Investigational Site

Salt, Jordan

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Pfizer Investigational Site

Chongoria, 60401, Kenya

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Pfizer Investigational Site

Nairobi, 00508, Kenya

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Pfizer Investigational Site

Adailiya, Kuwait

Location

Pfizer Investigational Site

Al Faḩāḩīl, Kuwait

Location

Pfizer Investigational Site

Kuwait City, Kuwait

Location

Pfizer Investigational Site

Mishrif, Kuwait

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Pfizer Investigational Site

Qadesya, Kuwait

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Pfizer Investigational Site

Yarmouk, Kuwait

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Pfizer Investigational Site

Jbeil, Lebanon, Lebanon, Lebanon

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Pfizer Investigational Site

Beirut, Lebanon

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Pfizer Investigational Site

Jounieh, Lebanon

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Pfizer Investigational Site

Tripoli, Lebanon

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Pfizer Investigational Site

Abuja, FCT, Nigeria

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Pfizer Investigational Site

Abuja, Garki, Nigeria

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Pfizer Investigational Site

Calabar, Nigeria

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Pfizer Investigational Site

Enugu, Nigeria

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Pfizer Investigational Site

Keffi, Nassarawa, Nigeria

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Pfizer Investigational Site

Dammam, Saudi Arabia

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Pfizer Investigational Site

Jeddah, Saudi Arabia

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Pfizer Investigational Site

Mecca, Saudi Arabia

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Pfizer Investigational Site

Riyadh, 11584, Saudi Arabia

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Pfizer Investigational Site

Riyadh, Saudi Arabia

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Pfizer Investigational Site

Yanbu, Saudi Arabia

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Pfizer Investigational Site

Dakar, Nabil Choucair, Senegal

Location

Pfizer Investigational Site

Dakar, Ouakam, Senegal

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Pfizer Investigational Site

Kedoungou, Senegal

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Pfizer Investigational Site

Kébémer, Senegal

Location

Pfizer Investigational Site

Saint-Louis, Senegal

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Pfizer Investigational Site

Ziguinchor, Senegal

Location

Pfizer Investigational Site

Halfway House, Gauteng, 1685, South Africa

Location

Pfizer Investigational Site

Sydenham, Durban, KwaZulu-Natal, 4091, South Africa

Location

Pfizer Investigational Site

Mokopane, Limpopo, 0600, South Africa

Location

Pfizer Investigational Site

Sheshego, Limpopo, 0742, South Africa

Location

Pfizer Investigational Site

Mamelodi East, Pretoria, 0122, South Africa

Location

Pfizer Investigational Site

Kwa-Zulu Natal, 4091, South Africa

Location

Pfizer Investigational Site

Rondebosch, 7700, South Africa

Location

Pfizer Investigational Site

Aryanah, 2073, Tunisia

Location

Pfizer Investigational Site

Bouficha, 4010, Tunisia

Location

Pfizer Investigational Site

Messaadine, 4013, Tunisia

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Pfizer Investigational Site

Sfax, 3013, Tunisia

Location

Pfizer Investigational Site

Tunis, 1000, Tunisia

Location

Pfizer Investigational Site

Zaghouan, 1100, Tunisia

Location

Pfizer Investigational Site

Abu Dhabi, United Arab Emirates

Location

Pfizer Investigational Site

Al Ain City, United Arab Emirates

Location

Pfizer Investigational Site

Dubai, United Arab Emirates

Location

Pfizer Investigational Site

Ras Al Khaima, United Arab Emirates

Location

Related Publications (4)

  • 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.

  • 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.

  • 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.

  • 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.

Related Links

Biospecimen

Retention: NONE RETAINED

Whole Blood

MeSH Terms

Conditions

ObesitySmokingDyslipidemiasDiabetes MellitusHypertension

Condition Hierarchy (Ancestors)

OverweightOvernutritionNutrition DisordersNutritional and Metabolic DiseasesBody WeightSigns and SymptomsPathological Conditions, Signs and SymptomsBehaviorLipid Metabolism DisordersMetabolic DiseasesGlucose Metabolism DisordersEndocrine System DiseasesVascular DiseasesCardiovascular Diseases

Study Officials

  • Pfizer CT.gov Call Center

    Pfizer

    STUDY DIRECTOR

Study Design

Study Type
observational
Observational Model
OTHER
Time Perspective
CROSS SECTIONAL
Sponsor Type
INDUSTRY
Responsible Party
SPONSOR

Study Record Dates

First Submitted

November 12, 2010

First Posted

November 18, 2010

Study Start

July 1, 2011

Primary Completion

April 1, 2012

Study Completion

April 1, 2012

Last Updated

February 18, 2021

Record last verified: 2021-02

Locations