Cardiovascular Risk Factors in an Ambulatory Urban Patient Population - Full Text View

Sponsor:	University of Heidelberg
Information provided by:	University of Heidelberg
ClinicalTrials.gov Identifier:	NCT00486993

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 Heart Diseases Metabolic Syndrome Smoking

U.S. FDA Resources

Further study details as provided by University of Heidelberg:

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 2011 (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

Contacts

Contact: Graciela Chaves, MD	+595-21-800-11-5000	gracechavesm@hotmail.com
Contact: Derliz Mereles, MD	+49-6221-652635	derliz@dmereles.de

Locations

Paraguay
Hospital Central Instituto de Prevision Social	Recruiting
Asuncion, Dep. Central, Paraguay, 1749
Contact: Graciela Chaves, MD +595-21-800-11-5000 gracechavesm@hotmail.com
Contact: Guillermo Oviedo, MD +595-21-800-11-5000 guivalop@yahoo.es
Principal Investigator: Graciela Chaves, MD
Principal Investigator: Derliz Mereles, MD
Principal Investigator: Guillermo Oviedo, MD
Principal Investigator: Nidia Britez, MD
Principal Investigator: Victoria Chaparro, MD
Principal Investigator: Graciela Gonzalez, MD

Sponsors and Collaborators

University of Heidelberg

Investigators

Principal Investigator:

Derliz Mereles, MD

University of Heidelberg

More Information

Additional Information:

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

Publications:

Jimenez JT, Palacios M, Canete 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:	Hospital Central, Instituto de Prevision Social, Instituto de Prevision Social
ClinicalTrials.gov Identifier:	NCT00486993 History of Changes
Other Study ID Numbers:	AsuRiesgo
Study First Received:	June 12, 2007
Last Updated:	June 3, 2008
Health Authority:	Paraguay: Institutional Review Board

Keywords provided by University of Heidelberg:

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 February 09, 2012