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

This study is ongoing, but not recruiting participants.
Sponsor:
Information provided by (Responsible Party):
Derliz Mereles, University of Heidelberg
ClinicalTrials.gov Identifier:
NCT00486993
First received: June 12, 2007
Last updated: February 24, 2014
Last verified: February 2014
  Purpose

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 Intervention
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 Type: Interventional
Study Design: Endpoint Classification: Efficacy Study
Intervention Model: Single Group Assignment
Masking: Open Label
Primary Purpose: Prevention
Official Title: Estimation of Prevalence and Assessment of the Effects of Modification of Cardiovascular Risk Factors in an Ambulatory Urban Patient Population

Resource links provided by NLM:


Further study details as provided by Heidelberg University:

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

Secondary Outcome Measures:
  • mortality, other causes [ Time Frame: one year ]
  • acute myocardial infarction [ Time Frame: one year ]
  • stroke [ Time Frame: one year ]
  • acute coronary syndrome [ Time Frame: one year ]

Estimated Enrollment: 7000
Study Start Date: May 2006
Estimated Study Completion Date: May 2016
Estimated Primary Completion Date: May 2014 (Final data collection date for primary outcome measure)
  Eligibility

Ages Eligible for Study:   18 Years and older
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
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
Please refer to this study by its ClinicalTrials.gov identifier: 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

Additional Information:
Publications:
Responsible Party: Derliz Mereles, Head Echocardiography Laboratory, University of Heidelberg
ClinicalTrials.gov Identifier: NCT00486993     History of Changes
Other Study ID Numbers: AsuRiesgo
Study First Received: June 12, 2007
Last Updated: February 24, 2014
Health Authority: Paraguay: Institutional Review Board

Keywords provided by Heidelberg University:
Diet
Exercise
Smoking
Stress
Polyphenols

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

ClinicalTrials.gov processed this record on April 17, 2014