Africa and Middle East Cardiovascular Epidemiological Study (ACE)
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Purpose
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.
| Condition |
|---|
|
Obesity Smoking Dyslipidemia Diabetes Mellitus Hypertension |
| Study Type: | Observational |
| Study Design: | Time Perspective: Cross-Sectional |
| Official Title: | Prevalence of Cardiovascular Risk Factors in Patients Attending General Practice Clinics in Selected Countries in the Africa and The Middle East Region |
- Prevalence of cardiovascular (CV) risk factors such as obesity, smoking, dyslipidemia, diabetes mellitus and hypertension [ Time Frame: At the time of the first visit ] [ Designated as safety issue: No ]
- 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 ] [ Designated as safety issue: No ]
- 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 ] [ Designated as safety issue: No ]
- 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 ] [ Designated as safety issue: No ]
- 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 ] [ Designated as safety issue: No ]
- 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 ] [ Designated as safety issue: No ]
Biospecimen Retention: None Retained
Whole Blood
| Enrollment: | 4386 |
| Study Start Date: | July 2011 |
| Study Completion Date: | April 2012 |
| Primary Completion Date: | April 2012 (Final data collection date for primary outcome measure) |
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| Ages Eligible for Study: | 18 Years and older |
| Genders Eligible for Study: | Both |
| Accepts Healthy Volunteers: | Yes |
| Sampling Method: | Probability Sample |
Subject selection would be from clinics in a primary care setting
Inclusion Criteria:
- Adult aged 18 or above
Exclusion Criteria:
- Pregnant women and/or lactating mothers
- Subjects presenting with any life threatening disease/condition
Contacts and Locations
Show 74 Study Locations| Study Director: | Pfizer CT.gov Call Center | Pfizer |
More Information
Additional Information:
No publications provided
| Responsible Party: | Pfizer |
| ClinicalTrials.gov Identifier: | NCT01243138 History of Changes |
| Other Study ID Numbers: | A2581186 |
| Study First Received: | November 12, 2010 |
| Last Updated: | June 25, 2012 |
| Health Authority: | United States: Food and Drug Administration |
Keywords provided by Pfizer:
|
Cross-sectional epidemiological study to evaluate the prevalence of CV risk factors in patients attending general practice in AfME region |
Additional relevant MeSH terms:
|
Diabetes Mellitus Hypertension Obesity Smoking Dyslipidemias Glucose Metabolism Disorders Metabolic Diseases Endocrine System Diseases Vascular Diseases |
Cardiovascular Diseases Overnutrition Nutrition Disorders Overweight Body Weight Signs and Symptoms Habits Lipid Metabolism Disorders |
ClinicalTrials.gov processed this record on May 16, 2013