AsuRiesgo: Cardiovascular Risk Factors in an Ambulatory Urban Patient Population

Sponsor
Heidelberg University (Other)
Overall Status
Completed
CT.gov ID
NCT00486993
Collaborator
(none)
18,287
1
98
186.6

Study Details

Study Description

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 Phase
  • 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

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 1, 2006
Actual Primary Completion Date :
Jul 1, 2014
Actual Study Completion Date :
Jul 1, 2014

Arms and Interventions

Arm 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

Primary Outcome Measures

  1. cardiovascular mortality [one year]

Secondary Outcome Measures

  1. mortality, other causes [one year]

  2. acute myocardial infarction [one year]

  3. stroke [one year]

  4. acute coronary syndrome [one year]

Eligibility Criteria

Criteria

Ages Eligible for Study:
18 Years and Older
Sexes Eligible for Study:
All
Accepts Healthy Volunteers:
No
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

Locations

Site City State Country Postal Code
1 Hospital Central Instituto de Prevision Social Asuncion Dep. Central Paraguay 1749

Sponsors and Collaborators

  • Heidelberg University

Investigators

  • Principal Investigator: Derliz Mereles, MD, Heidelberg University

Study Documents (Full-Text)

None provided.

More Information

Additional Information:

Publications

Responsible Party:
Derliz Mereles, Head Echocardiography Laboratory, Heidelberg University
ClinicalTrials.gov Identifier:
NCT00486993
Other Study ID Numbers:
  • AsuRiesgo
First Posted:
Jun 15, 2007
Last Update Posted:
Nov 8, 2016
Last Verified:
Nov 1, 2016
Keywords provided by Derliz Mereles, Head Echocardiography Laboratory, Heidelberg University
Additional relevant MeSH terms:

Study Results

No Results Posted as of Nov 8, 2016