Cardiovascular Risk FactorsAsuRiesgoNCT00486993
Cardiovascular Risk Factors in an Ambulatory Urban Patient Population
An observational study of Cardiovascular Risk Factors and Metabolic Syndrome, run by Heidelberg University at 1 site in Paraguay.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Cardiovascular Risk Factors, Metabolic Syndrome, Lifestyle Modification
- What is being tested?
- Dietary and nutritional modification, Stop smoking and Regular physical activities
- Type of treatment
- Lifestyle or therapy programme
- How many people
- 18,287 participants
- Where
- 1 siteParaguay
- Study dates
- May 2006to Jul 2014
- Phase
- Observational
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Study population: unselected outpatient population
Who may be able to join
- all ambulatory patients, with age 18 years or older
Who cannot join
- no exclusion criteria provided, particularly for the first, epidemiological part of the study
Trial locations and contacts
1 site in 1 country.
Paraguay1 site
Hospital Central Instituto de Prevision Social
Asunción, Dep. Central, 1749
About this study
Official title: Estimation of Prevalence and Assessment of the Effects of Modification of Cardiovascular Risk Factors in an Ambulatory Urban Patient Population
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.
Read more
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.
- Conditions
- Cardiovascular Risk Factors, Metabolic Syndrome, Lifestyle Modification, Coronary Artery Disease, Stroke
- Being tested
- Dietary and nutritional modification, Stop smoking, Regular physical activities, Weight reduction to normal ranges, Regular intake of polyphenols, esp. from Ilex paraguayensis
- Keywords
- Diet, Exercise, Smoking, Stress, Polyphenols
- Medical subject headings
- Metabolic Syndrome, Coronary Artery Disease, Stroke, Motor Activity, Smoking
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Dietary and nutritional modificationBehavioural
Stop smokingBehavioural
Regular physical activitiesBehavioural
Weight reduction to normal rangesBehavioural
Regular intake of polyphenols, esp. from Ilex paraguayensisBehavioural
| Study group | Role | What they receive |
|---|---|---|
| asuriesgo | unselected outpatient population Receives: 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 |
What is being measured
The primary outcome is the main question the study is designed to answer.
cardiovascular mortality
Measured: one year
Secondary outcomes (4)
mortality, other causes
Measured: one year
acute myocardial infarction
Measured: one year
stroke
Measured: one year
acute coronary syndrome
Measured: one year
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted15 Jun 2007 (estimated)
- Study startMay 2006
- Primary completionJul 2014
- Study completionJul 2014
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (2)Papers the sponsor has linked to this study.
- Other trials for Cardiovascular Risk FactorsStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Cohort
- Time perspective
- Prospective
- Enrolment
- 18,287 participants (actual)
Sponsor and investigators
- Lead sponsor
- Heidelberg University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Derliz Mereles, Heidelberg University
- Investigators
- Derliz Mereles, MD, Principal investigator, Heidelberg University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00486993
- Sponsor's protocol ID
- AsuRiesgo
- Acronym
- AsuRiesgo
- Status last verified
- Nov 2016
- First submitted
- 12 Jun 2007
- Last updated
- 8 Nov 2016
- Results posted
- No
- Data monitoring committee
- Yes
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. doi: 10.1002/(SICI)1096-9136(199804)15:43.0.CO;2-Z.
PubMed 9585400Ramirez 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.
PubMed 8583468
Study at a glance
From the registry record, last updated by the sponsor on 8 Nov 2016. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Estimation of Prevalence and Assessment of the Effects of Modification of Cardiovascular Risk Factors in an Ambulatory Urban Patient Population
- ClinicalTrials.gov ID
- NCT00486993
- Acronym / sponsor ID
- AsuRiesgo / AsuRiesgo
- Conditions
- Cardiovascular Risk Factors, Metabolic Syndrome, Lifestyle Modification, Coronary Artery Disease, Stroke
- Keywords
- Diet, Exercise, Smoking, Stress, Polyphenols
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 18,287 participants (actual)
- Lead sponsor
- Heidelberg UniversityUniversity, hospital or other
- Study start
- May 2006
- Primary completion
- Jul 2014 (actual)
- Study completion
- Jul 2014 (actual)
- First posted
- 15 Jun 2007 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| asuriesgo | – | 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 paraguayensisunselected outpatient population |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- unselected outpatient population
Key inclusion criteria (1 listed)
- all ambulatory patients, with age 18 years or older
Key exclusion criteria (1 listed)
- no exclusion criteria provided, particularly for the first, epidemiological part of the study
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Dietary and nutritional modification | Behavioural | asuriesgo |
| Stop smoking | Behavioural | asuriesgo |
| Regular physical activities | Behavioural | asuriesgo |
| Weight reduction to normal ranges | Behavioural | asuriesgo |
| Regular intake of polyphenols, esp. from Ilex paraguayensis | Behavioural | asuriesgo |
Primary outcome
cardiovascular mortality
Time frame: one year
4 secondary outcomes
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
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 8 Nov 2016.
- Background: PubMed 9585400Jimenez 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.
- Background: PubMed 8583468Ramirez 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.
- Internet site of the studyLink provided by the sponsor.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Derliz Mereles, MD principal investigator
Heidelberg University
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Cardiovascular Risk Factors and Metabolic Syndrome, run by Heidelberg University at 1 site in Paraguay.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 1 inclusion and 1 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 8 Nov 2016. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Paraguay. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
cardiovascular mortality (time frame: one year). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT00486993, which also lists 2 linked publications.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 8 Nov 2016.