NCT00486993

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.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
18,287

participants targeted

Target at P75+ for all trials

Timeline
Completed

Started May 2006

Longer than P75 for all trials

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

May 1, 2006

Completed
1.1 years until next milestone

First Submitted

Initial submission to the registry

June 12, 2007

Completed
3 days until next milestone

First Posted

Study publicly available on registry

June 15, 2007

Completed
7 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

July 1, 2014

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

July 1, 2014

Completed
Last Updated

November 8, 2016

Status Verified

November 1, 2016

Enrollment Period

8.2 years

First QC Date

June 12, 2007

Last Update Submit

November 5, 2016

Conditions

Cardiovascular Risk FactorsMetabolic SyndromeLifestyle ModificationCoronary Artery DiseaseStroke

Keywords

DietExerciseSmokingStressPolyphenols

Outcome Measures

Primary Outcomes (1)

  • cardiovascular mortality

    one year

Secondary Outcomes (4)

  • mortality, other causes

    one year

  • acute myocardial infarction

    one year

  • stroke

    one year

  • acute coronary syndrome

    one year

Study Arms (1)

asuriesgo

unselected outpatient population

Behavioral: Dietary and nutritional modificationBehavioral: Stop smokingBehavioral: Regular physical activitiesBehavioral: Weight reduction to normal rangesBehavioral: Regular intake of polyphenols, esp. from Ilex paraguayensis

Interventions

Dietary and nutritional modificationBEHAVIORAL
asuriesgo
Stop smokingBEHAVIORAL
asuriesgo
Regular physical activitiesBEHAVIORAL
asuriesgo
Weight reduction to normal rangesBEHAVIORAL
asuriesgo
Regular intake of polyphenols, esp. from Ilex paraguayensisBEHAVIORAL
asuriesgo

Eligibility Criteria

Age18 Years+
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)
Sampling MethodNon-Probability Sample
Study Population

unselected outpatient population

You may qualify if:

  • all ambulatory patients, with age 18 years or older

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Hospital Central Instituto de Prevision Social

Asunción, Dep. Central, 1749, Paraguay

Location

Related Publications (2)

  • 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.

    PMID: 9585400BACKGROUND

  • 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.

    PMID: 8583468BACKGROUND

Related Links

MeSH Terms

Conditions

Metabolic SyndromeCoronary Artery DiseaseStrokeMotor ActivitySmoking

Interventions

Diet

Condition Hierarchy (Ancestors)

Insulin ResistanceHyperinsulinismGlucose Metabolism DisordersMetabolic DiseasesNutritional and Metabolic DiseasesCoronary DiseaseMyocardial IschemiaHeart DiseasesCardiovascular DiseasesArteriosclerosisArterial Occlusive DiseasesVascular DiseasesCerebrovascular DisordersBrain DiseasesCentral Nervous System DiseasesNervous System DiseasesBehavior

Intervention Hierarchy (Ancestors)

Nutritional Physiological PhenomenaDiet, Food, and NutritionPhysiological Phenomena

Study Officials

  • Derliz Mereles, MD

    Heidelberg University

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
observational
Observational Model
COHORT
Time Perspective
PROSPECTIVE
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Head Echocardiography Laboratory

Study Record Dates

First Submitted

June 12, 2007

First Posted

June 15, 2007

Study Start

May 1, 2006

Primary Completion

July 1, 2014

Study Completion

July 1, 2014

Last Updated

November 8, 2016

Record last verified: 2016-11

Locations

PA(1)