Cardiovascular Risk Factors in an Ambulatory Urban Patient Population

Stroke Clinical Trial

— AsuRiesgo  

Official title:

Estimation of Prevalence and Assessment of the Effects of Modification of Cardiovascular Risk Factors in an Ambulatory Urban Patient Population

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT00486993
• Other study ID #: AsuRiesgo
• Status: Completed
• Phase: N/A
• First received: June 12, 2007
• Last updated: November 5, 2016
• Start date: May 2006
• Est. completion date: July 2014

Study information

• Verified date: November 2016
• Source: Heidelberg University
• Contact: n/a
• Is FDA regulated: No
• Health authority: Paraguay: Institutional Review Board
• Study type: Observational

Clinical Trial 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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 18287
• Est. completion date: July 2014
• Est. primary completion date: July 2014
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 18 Years and older

Eligibility

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

Observational Model: Cohort, Time Perspective: Prospective

Related Conditions & MeSH terms

• Cardiovascular Risk Factors
• Coronary Artery Disease
• Coronary Disease
• Lifestyle Modification
• Metabolic Syndrome
• Metabolic Syndrome X
• Myocardial Ischemia
• Stroke

Intervention

Behavioral:
• Dietary and nutritional modification

• Stop smoking

• Regular physical activities

• Weight reduction to normal ranges

• Regular intake of polyphenols, esp. from Ilex paraguayensis

Locations

Country	Name	City	State
Paraguay	Hospital Central Instituto de Prevision Social	Asuncion	Dep. Central

Sponsors (1)

Lead Sponsor	Collaborator
Heidelberg University

Country where clinical trial is conducted

Paraguay, 

References & Publications (2)

Jimenez JT, Palacios M, Cañete F, Barriocanal LA, Medina U, Figueredo R, Martinez S, de Melgarejo MV, Weik S, Kiefer R, Alberti KG, Moreno-Azorero R. Prevalence of diabetes mellitus and associated cardiovascular risk factors in an adult urban population in Paraguay. Diabet Med. 1998 Apr;15(4):334-8. — View Citation

Ramirez MO, Pino CT, Furiasse LV, Lee AJ, Fowkes FG. Paraguayan National Blood Pressure Study: prevalence of hypertension in the general population. J Hum Hypertens. 1995 Nov;9(11):891-7. — View Citation

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	cardiovascular mortality		one year	No
Secondary	mortality, other causes		one year	No
Secondary	acute myocardial infarction		one year	No
Secondary	stroke		one year	No
Secondary	acute coronary syndrome		one year	No

External Links

•   Internet site of the study