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| Sponsored by: |
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: | Prevention, Open Label, Uncontrolled, Single Group Assignment, Efficacy Study |
| Official Title: | Estimation of Prevalence and Assessment of the Effects of Modification of Cardiovascular Risk Factors in an Ambulatory Urban Patient Population |
| 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 |
Inclusion Criteria:
Exclusion Criteria:
Contacts and Locations| Contact: Graciela Chaves, MD | +595-21-800-11-5000 | gracechavesm@hotmail.com |
| Contact: Derliz Mereles, MD | +49-6221-652635 | derliz@dmereles.de |
| Paraguay, Dep. Central | |
| 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 | |
| Principal Investigator: | Derliz Mereles, MD | University of Heidelberg |
More Information
| Responsible Party: | Instituto de Prevision Social ( Hospital Central, Instituto de Prevision Social ) |
| Study ID Numbers: | AsuRiesgo |
| Study First Received: | June 12, 2007 |
| Last Updated: | June 3, 2008 |
| ClinicalTrials.gov Identifier: | NCT00486993 |
| Health Authority: | Paraguay: Institutional Review Board |
|
Diet Exercise Smoking Stress Polyphenols |
|
Arterial Occlusive Diseases Coronary Disease Smoking Heart Diseases Cerebral Infarction Myocardial Ischemia |
Stroke Vascular Diseases Stress Arteriosclerosis Ischemia Coronary Artery Disease |
|
Pathologic Processes Disease Syndrome Cardiovascular Diseases |
