Africa and Middle East Cardiovascular Epidemiological Study (ACE)

This study has been completed.
Sponsor:
Information provided by (Responsible Party):
Pfizer
ClinicalTrials.gov Identifier:
NCT01243138
First received: November 12, 2010
Last updated: June 25, 2012
Last verified: June 2012
  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

Resource links provided by NLM:


Further study details as provided by Pfizer:

Primary Outcome Measures:
  • 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 ]

Secondary Outcome Measures:
  • 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)
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

Ages Eligible for Study:   18 Years and older
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   Yes
Sampling Method:   Probability Sample
Study Population

Subject selection would be from clinics in a primary care setting

Criteria

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
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT01243138

  Show 74 Study Locations
Sponsors and Collaborators
Pfizer
Investigators
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 July 22, 2014