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

History of Changes

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:

MedlinePlus related topics: Coronary Artery Disease Smoking

U.S. FDA Resources

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

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

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:

Internet site of the study This link exits the ClinicalTrials.gov site

Publications:

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.

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.


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 Arterial Occlusive Diseases Arteriosclerosis Cardiovascular Diseases	Coronary Disease Heart Diseases Myocardial Ischemia Vascular Diseases

ClinicalTrials.gov processed this record on March 03, 2015

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