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Trial record 1 of 1 for:    NCT01243138
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Africa and Middle East Cardiovascular Epidemiological Study (ACE)

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT01243138
Recruitment Status : Completed
First Posted : November 18, 2010
Last Update Posted : June 27, 2012
Sponsor:
Information provided by (Responsible Party):
Pfizer

Tracking Information
First Submitted Date November 12, 2010
First Posted Date November 18, 2010
Last Update Posted Date June 27, 2012
Study Start Date July 2011
Actual Primary Completion Date April 2012   (Final data collection date for primary outcome measure)
Current Primary Outcome Measures
 (submitted: November 16, 2010)
Prevalence of cardiovascular (CV) risk factors such as obesity, smoking, dyslipidemia, diabetes mellitus and hypertension [ Time Frame: At the time of the first visit ]
Original Primary Outcome Measures Same as current
Change History
Current Secondary Outcome Measures
 (submitted: November 16, 2010)
  • 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 ]
Original Secondary Outcome Measures Same as current
Current Other Pre-specified Outcome Measures Not Provided
Original Other Pre-specified Outcome Measures Not Provided
 
Descriptive Information
Brief Title 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
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.

Study Type Observational
Study Design Time Perspective: Cross-Sectional
Target Follow-Up Duration Not Provided
Biospecimen Retention:   None Retained
Description:
Whole Blood
Sampling Method Probability Sample
Study Population Subject selection would be from clinics in a primary care setting
Condition
  • Obesity
  • Smoking
  • Dyslipidemia
  • Diabetes Mellitus
  • Hypertension
Intervention Not Provided
Study Groups/Cohorts Not Provided
Publications *

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruitment Information
Recruitment Status Completed
Actual Enrollment
 (submitted: June 25, 2012)
4386
Original Estimated Enrollment
 (submitted: November 16, 2010)
4300
Actual Study Completion Date April 2012
Actual Primary Completion Date April 2012   (Final data collection date for primary outcome measure)
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
Sex/Gender
Sexes Eligible for Study: All
Ages 18 Years and older   (Adult, Older Adult)
Accepts Healthy Volunteers Yes
Contacts Contact information is only displayed when the study is recruiting subjects
Listed Location Countries Algeria,   Cameroon,   Egypt,   Ghana,   Jordan,   Kenya,   Kuwait,   Lebanon,   Nigeria,   Saudi Arabia,   Senegal,   South Africa,   Tunisia,   United Arab Emirates
Removed Location Countries  
 
Administrative Information
NCT Number NCT01243138
Other Study ID Numbers A2581186
Has Data Monitoring Committee No
U.S. FDA-regulated Product Not Provided
IPD Sharing Statement Not Provided
Responsible Party Pfizer
Study Sponsor Pfizer
Collaborators Not Provided
Investigators
Study Director: Pfizer CT.gov Call Center Pfizer
PRS Account Pfizer
Verification Date June 2012