|
Main
|
|
Note: This record shows only the 20 elements of the WHO Trial Registration Data Set. To view changes that have been made to the source record, or for additional information about this trial, click on the URL below to go to the source record in the primary register. |
|
Register:
|
ClinicalTrials.gov |
|
Last refreshed on:
|
17 October 2012 |
|
Main ID: |
NCT00486993 |
|
Date of registration:
|
12/06/2007 |
|
Primary sponsor: |
|
|
Public title:
|
Cardiovascular Risk Factors in an Ambulatory Urban Patient Population
AsuRiesgo |
|
Scientific title:
|
Estimation of Prevalence and Assessment of the Effects of Modification of Cardiovascular Risk Factors in an Ambulatory Urban Patient Population |
|
Date of first enrolment:
|
May 2006 |
|
Target sample size:
|
7000 |
|
Recruitment status: |
Recruiting |
|
URL:
|
http://clinicaltrials.gov/show/NCT00486993 |
|
Study type:
|
Interventional |
|
Study design:
|
Endpoint Classification: Efficacy Study, Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Prevention
|
|
|
Countries of recruitment
|
|
Paraguay
| | | | | | | |
|
Contacts
|
|
Name:
|
Graciela Chaves, MD |
|
Address:
|
|
|
Telephone:
|
+595-21-800-11-5000 |
|
Email:
|
gracechavesm@hotmail.com |
|
Affiliation:
|
|
|
|
Name:
|
Graciela Chaves, MD |
|
Address:
|
|
|
Telephone:
|
+595-21-800-11-5000 |
|
Email:
|
gracechavesm@hotmail.com |
|
Affiliation:
|
|
|
|
Name:
|
Derliz Mereles, MD |
|
Address:
|
|
|
Telephone:
|
|
|
Email:
|
|
|
Affiliation:
|
University of Heidelberg |
|
|
Key inclusion & exclusion 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
Age minimum:
18 Years
Age maximum:
N/A
Gender:
Both
|
|
Health Condition(s) or Problem(s) studied
|
|
Cardiovascular Risk Factors
|
|
Coronary Artery Disease
|
|
Lifestyle Modification
|
|
Metabolic Syndrome
|
|
Stroke
|
|
Intervention(s)
|
|
Behavioral: Dietary and nutritional modification
|
|
Behavioral: Regular intake of polyphenols, esp. from Ilex paraguayensis
|
|
Behavioral: Regular physical activities
|
|
Behavioral: Stop smoking
|
|
Behavioral: Weight reduction to normal ranges
|
|
Primary Outcome(s)
|
|
cardiovascular mortality
[Time Frame: one year]
|
|
Secondary Outcome(s)
|
|
acute coronary syndrome
[Time Frame: one year]
|
|
acute myocardial infarction
[Time Frame: one year]
|
|
mortality, other causes
[Time Frame: one year]
|
|
stroke
[Time Frame: one year]
|
|
Secondary ID(s)
|
|
AsuRiesgo
|
|
Source(s) of Monetary Support
|
|
Please refer to primary and secondary sponsors
|
|