Clinical trial NCT01243138: Africa and Middle East Cardiovascular Epidemiological Study
Official title: Prevalence of Cardiovascular Risk Factors in Patients Attending General Practice Clinics in Selected Countries in the Africa and The Middle East Region
Study type: OBSERVATIONAL
Overall status: COMPLETED
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
Lead sponsor: Pfizer
Sponsor class: INDUSTRY
First posted: 2010-11-18
Enrollment: 4386
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Observational model: OTHER
Time perspective: CROSS_SECTIONAL
Sampling method: PROBABILITY_SAMPLE
Study population: Subject selection would be from clinics in a primary care setting

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.

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.

Eligibility criteria: Inclusion Criteria:

* Adult aged 18 or above

Exclusion Criteria:

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

Primary outcomes:
measure: Prevalence of cardiovascular (CV) risk factors such as obesity, smoking, dyslipidemia, diabetes mellitus and hypertension
timeFrame: At the time of the first visit
Secondary outcomes:
measure: Compare the prevalence of cardiovascular (CV) risk factors such as obesity, smoking, dyslipidaemia, diabetes mellitus and hypertension in the urban and rural population.
timeFrame: At the time of the first visit
measure: Compare the prevalence of CV risk factors such as obesity, smoking, dyslipidaemia, diabetes mellitus and hypertension in the male and female population.
timeFrame: At the time of the first visit
measure: Stratifying the prevalence of CV risk factors such as obesity, smoking, dyslipidaemia, diabetes mellitus and hypertension by age groups.
timeFrame: At the time of the first visit
measure: 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.
timeFrame: At the time of the first visit
measure: Ascertain the most commonly used medications in those that have been previously diagnosed as diabetic, hypertensive or dyslipidaemic.
timeFrame: At the time of the first visit
Other outcomes:
Locations:
city: Alger
country: Algeria
facility: Pfizer Investigational Site
city: Bejaja
country: Algeria
facility: Pfizer Investigational Site
city: Djelfa
country: Algeria
facility: Pfizer Investigational Site
city: Laghouat
country: Algeria
facility: Pfizer Investigational Site
city: M'Sila
country: Algeria
facility: Pfizer Investigational Site
city: Relizane
country: Algeria
facility: Pfizer Investigational Site
city: Saida
country: Algeria
facility: Pfizer Investigational Site
city: Tebessa
country: Algeria
facility: Pfizer Investigational Site
city: Tlemcen
country: Algeria
facility: Pfizer Investigational Site
city: Yaounde
country: Cameroon
facility: Pfizer Investigational Site
state: Cite Verte
city: Douala
country: Cameroon
facility: Pfizer Investigational Site
state: Deido
city: Bafoussam
country: Cameroon
facility: Pfizer Investigational Site
city: Mbandjock
country: Cameroon
facility: Pfizer Investigational Site
city: Njombe
country: Cameroon
facility: Pfizer Investigational Site
city: Soa
country: Cameroon
facility: Pfizer Investigational Site
city: Alexandria
country: Egypt
facility: Pfizer Investigational Site
city: Cairo
country: Egypt
facility: Pfizer Investigational Site
city: Shiben Al Kom
country: Egypt
facility: Pfizer Investigational Site
city: Tanta
country: Egypt
facility: Pfizer Investigational Site
city: Accra
country: Ghana
facility: Pfizer Investigational Site
city: Jachie-Ashanti
country: Ghana
facility: Pfizer Investigational Site
city: Kumasi
country: Ghana
facility: Pfizer Investigational Site
city: Sogakope V/R
country: Ghana
facility: Pfizer Investigational Site
city: Takoradi
country: Ghana
facility: Pfizer Investigational Site
city: Amman
country: Jordan
facility: Pfizer Investigational Site
city: Irbid
country: Jordan
facility: Pfizer Investigational Site
city: Salt
country: Jordan
facility: Pfizer Investigational Site
city: Chongoria
country: Kenya
facility: Pfizer Investigational Site
city: Nairobi
country: Kenya
facility: Pfizer Investigational Site
city: Adailiya
country: Kuwait
facility: Pfizer Investigational Site
city: Fahaheel
country: Kuwait
facility: Pfizer Investigational Site
city: Kuwait
country: Kuwait
facility: Pfizer Investigational Site
city: Mishref
country: Kuwait
facility: Pfizer Investigational Site
city: Qadesya
country: Kuwait
facility: Pfizer Investigational Site
city: Yarmouk
country: Kuwait
facility: Pfizer Investigational Site
city: Beirut
country: Lebanon
facility: Pfizer Investigational Site
city: Jbeil, Lebanon
country: Lebanon
facility: Pfizer Investigational Site
city: Jounieh
country: Lebanon
facility: Pfizer Investigational Site
city: Tripoli
country: Lebanon
facility: Pfizer Investigational Site
city: Abuja, FCT
country: Nigeria
facility: Pfizer Investigational Site
city: Abuja, Garki
country: Nigeria
facility: Pfizer Investigational Site
city: Calabar
country: Nigeria
facility: Pfizer Investigational Site
city: Enugu
country: Nigeria
facility: Pfizer Investigational Site
city: Keffi, Nassarawa
country: Nigeria
facility: Pfizer Investigational Site
city: Dammam
country: Saudi Arabia
facility: Pfizer Investigational Site
city: Jeddah 21573
country: Saudi Arabia
facility: Pfizer Investigational Site
city: Jeddah
country: Saudi Arabia
facility: Pfizer Investigational Site
city: Makkah
country: Saudi Arabia
facility: Pfizer Investigational Site
city: Riyadh
country: Saudi Arabia
facility: Pfizer Investigational Site
city: Riyadh
country: Saudi Arabia
facility: Pfizer Investigational Site
city: Yanbu
country: Saudi Arabia
facility: Pfizer Investigational Site
city: Dakar
country: Senegal
facility: Pfizer Investigational Site
state: Nabil Choucair
city: Dakar
country: Senegal
facility: Pfizer Investigational Site
state: Ouakam
city: Kebemer
country: Senegal
facility: Pfizer Investigational Site
city: Kedoungou
country: Senegal
facility: Pfizer Investigational Site
city: Saint Louis
country: Senegal
facility: Pfizer Investigational Site
city: Ziguinchor
country: Senegal
facility: Pfizer Investigational Site
city: Halfway House
country: South Africa
facility: Pfizer Investigational Site
state: Gauteng
city: Sydenham, Durban
country: South Africa
facility: Pfizer Investigational Site
state: Kwazulu-natal
city: Mokopane
country: South Africa
facility: Pfizer Investigational Site
state: Limpopo
city: Sheshego
country: South Africa
facility: Pfizer Investigational Site
state: Limpopo
city: Mamelodi East
country: South Africa
facility: Pfizer Investigational Site
state: Pretoria
city: Kwa-Zulu Natal
country: South Africa
facility: Pfizer Investigational Site
city: Rondebosch
country: South Africa
facility: Pfizer Investigational Site
city: Ariana
country: Tunisia
facility: Pfizer Investigational Site
city: Bouficha
country: Tunisia
facility: Pfizer Investigational Site
city: Messaadine
country: Tunisia
facility: Pfizer Investigational Site
city: Sfax
country: Tunisia
facility: Pfizer Investigational Site
city: Tunis
country: Tunisia
facility: Pfizer Investigational Site
city: Zaghouan
country: Tunisia
facility: Pfizer Investigational Site
city: Abu Dhabi
country: United Arab Emirates
facility: Pfizer Investigational Site
city: Al Ain
country: United Arab Emirates
facility: Pfizer Investigational Site
city: Dubai
country: United Arab Emirates
facility: Pfizer Investigational Site
city: Ras Al Khaima
country: United Arab Emirates
facility: Pfizer Investigational Site
Study officials:
affiliation: Pfizer
name: Pfizer CT.gov Call Center
role: STUDY_DIRECTOR
References:
citation: 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.
citation: 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.
citation: 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.
citation: 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.