Cardiovascular Risk Factors in an Ambulatory Urban Patient Population

Completed

• Conditions: Coronary Artery Disease; Cardiovascular Risk Factors; Lifestyle Modification; Metabolic Syndrome; Stroke
• Interventions: 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

• Registration Number: NCT00486993
• Lead Sponsor: Heidelberg University

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.

Detailed Description

Not available

Study Timeline

• Study Start: 2006-05
• Study First Submitted: 2007-06-12
• Study First Submitted QC: 2007-06-14
• Study First Posted: 2007-06-15
• Primary Completion: 2014-07
• Study Completion: 2014-07
• Status Verified: 2016-11
• Last Update Submitted: 2016-11-05
• Last Update Posted: 2016-11-08

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 18287

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

Study & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Arm && Interventions

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

Primary Outcome Measures

Name	Time	Method
cardiovascular mortality	one year

Secondary Outcome Measures

Name	Time	Method
acute myocardial infarction	one year
stroke	one year
mortality, other causes	one year
acute coronary syndrome	one year

Trial Locations

Locations (1)

Hospital Central Instituto de Prevision Social; 🇵🇾 Asuncion, Dep. Central, Paraguay