Clinical trial NCT00486993: Cardiovascular Risk Factors in an Ambulatory Urban Patient Population
Official title: Estimation of Prevalence and Assessment of the Effects of Modification of Cardiovascular Risk Factors in an Ambulatory Urban Patient Population
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Cardiovascular Risk Factors
Metabolic Syndrome
Lifestyle Modification
Coronary Artery Disease
Stroke
Keywords: Diet
Exercise
Smoking
Stress
Polyphenols
Lead sponsor: Heidelberg University
Sponsor class: OTHER
First posted: 2007-06-15
Enrollment: 18287
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: COHORT
Time perspective: PROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: unselected outpatient population

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.


Eligibility 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

Primary outcomes:
measure: cardiovascular mortality
timeFrame: one year
Secondary outcomes:
measure: mortality, other causes
timeFrame: one year
measure: acute myocardial infarction
timeFrame: one year
measure: stroke
timeFrame: one year
measure: acute coronary syndrome
timeFrame: one year
Other outcomes:
Locations:
city: Asuncion
country: Paraguay
facility: Hospital Central Instituto de Prevision Social
state: Dep. Central
Study officials:
affiliation: Heidelberg University
name: Derliz Mereles, MD
role: PRINCIPAL_INVESTIGATOR
References:
citation: 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. doi: 10.1002/(SICI)1096-9136(199804)15:43.0.CO;2-Z.
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.