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Cardiovascular Risk Factors in an Ambulatory Urban Patient Population (AsuRiesgo)

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ClinicalTrials.gov Identifier: NCT00486993
Recruitment Status : Completed
First Posted : June 15, 2007
Last Update Posted : November 8, 2016
Sponsor:
Information provided by (Responsible Party):
Derliz Mereles, Heidelberg University

Study Description
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Study Description Study Design Groups and Cohorts Outcome Measures Eligibility Criteria Contacts and Locations More Information
Brief Summary:

According to WHO estimations, cardiovascular diseases (CVDs) are the number one cause of death globally. More people die annually from CVDs than from any other cause. An estimated 17.5 million people died from CVDs in 2005, representing 30% of all global deaths. Of these deaths, an estimated 7.6 million were due to coronary heart disease and 5.7 million were due to stroke.

Over 80% of CVD deaths take place in low- and middle-income countries and occur almost equally in men and women. In Paraguay, prevalence of classic risk factors, as well as new ones, like the metabolic syndrome are not completely known.

Government health policies in industrialized countries are focusing on programs to modify cardiovascular risk factors. In developing countries, prevention of coronary heart disease and stroke through modification of cardiovascular risk factors are not playing a large role at the moment.

The aim of this study is to define the effects of changes in lifestyle on cardiovascular risk factors, when added to optimized standard pharmacological therapy for arterial hypertension, diabetes mellitus and hyperlipidemia, in an ambulatory urban patient population.


Condition or disease Intervention/treatment
Cardiovascular Risk Factors Metabolic Syndrome Lifestyle Modification Coronary Artery Disease Stroke Behavioral: Dietary and nutritional modification Behavioral: Stop smoking Behavioral: Regular physical activities Behavioral: Weight reduction to normal ranges Behavioral: Regular intake of polyphenols, esp. from Ilex paraguayensis

Study Design
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Study Type : Observational
Actual Enrollment : 18287 participants
Observational Model: Cohort
Time Perspective: Prospective
Official Title: Estimation of Prevalence and Assessment of the Effects of Modification of Cardiovascular Risk Factors in an Ambulatory Urban Patient Population
Study Start Date : May 2006
Actual Primary Completion Date : July 2014
Actual Study Completion Date : July 2014

Resource links provided by the National Library of Medicine

U.S. FDA Resources

Groups and Cohorts
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Study Description Study Design Groups and Cohorts Outcome Measures Eligibility Criteria Contacts and Locations More Information

Group/Cohort Intervention/treatment
asuriesgo
unselected outpatient population
 Behavioral: Dietary and nutritional modification Behavioral: Stop smoking Behavioral: Regular physical activities Behavioral: Weight reduction to normal ranges Behavioral: Regular intake of polyphenols, esp. from Ilex paraguayensis


Outcome Measures
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Study Description Study Design Groups and Cohorts Outcome Measures Eligibility Criteria Contacts and Locations More Information

Primary Outcome Measures :
  1. cardiovascular mortality [ Time Frame: one year ]

Secondary Outcome Measures :
  1. mortality, other causes [ Time Frame: one year ]
  2. acute myocardial infarction [ Time Frame: one year ]
  3. stroke [ Time Frame: one year ]
  4. acute coronary syndrome [ Time Frame: one year ]

Eligibility Criteria
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Study Description Study Design Groups and Cohorts Outcome Measures Eligibility Criteria Contacts and Locations More Information

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Ages Eligible for Study:   18 Years and older   (Adult, Senior)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Sampling Method:   Non-Probability Sample
Study Population
unselected outpatient population
Criteria

Inclusion Criteria:

  • all ambulatory patients, with age 18 years or older

Exclusion Criteria:

  • no exclusion criteria provided, particularly for the first, epidemiological part of the study
Contacts and Locations
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Study Description Study Design Groups and Cohorts Outcome Measures Eligibility Criteria Contacts and Locations More Information

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT00486993


Locations
Paraguay
Hospital Central Instituto de Prevision Social
Asuncion, Dep. Central, Paraguay, 1749
Sponsors and Collaborators
Heidelberg University
Investigators
Principal Investigator: Derliz Mereles, MD Heidelberg University
More Information
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Study Description Study Design Groups and Cohorts Outcome Measures Eligibility Criteria Contacts and Locations More Information

Additional Information:
Internet site of the study  This link exits the ClinicalTrials.gov site

Publications:

Responsible Party: Derliz Mereles, Head Echocardiography Laboratory, Heidelberg University
ClinicalTrials.gov Identifier: NCT00486993     History of Changes
Other Study ID Numbers: AsuRiesgo
First Posted: June 15, 2007    Key Record Dates
Last Update Posted: November 8, 2016
Last Verified: November 2016

Keywords provided by Derliz Mereles, Heidelberg University:
Diet
Exercise
Smoking
Stress
Polyphenols

Additional relevant MeSH terms:
Coronary Artery Disease
Myocardial Ischemia
Coronary Disease
Metabolic Syndrome X
Heart Diseases
Cardiovascular Diseases
Arteriosclerosis
 Arterial Occlusive Diseases
Vascular Diseases
Insulin Resistance
Hyperinsulinism
Glucose Metabolism Disorders
Metabolic Diseases