Cardiovascular Primary PreventionRISKNCT01889030
Cardiovascular Risk Stratification of Ambulatory Patients in Primary Prevention
An observational study of Cardiovascular Primary Prevention, run by AstraZeneca at 1 site in Argentina.
Trial summary
This is an observational, cross-sectional, national multicenter study, trying to obtain local data about the global cardiovascular risk profile of patients attending ambulatory offices of general practitioners and cardiologists. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Cardiovascular Primary Prevention
- How many people
- 516 participants
- Where
- 1 siteArgentina
- Study dates
- Jul 2013to Jun 2014
- How long will I take part?
- 1 Day
- 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: Patients older than 18 years old, without known vascular disease (primary prevention) under follow-up by the investigator, whose medical records were initiated during the past 3 years and have completed their baseline assessment of CV risk
Who may be able to join
- Patients older than 18 years of age, who give their written consent to take part.
- Patients without known vascular disease (primary prevention) under follow-up by the investigator, whose medical records have been initiated during the last 3 years.
- Patients who have completed their baseline CV risk assessment Lipid lowering treatment naive patients at the time of the stratification.
Who cannot join
- Incomplete or missing medical record data.
- Subjects with prior cardiovascular disease (peripheral vascular disease, coronary or cerebrovascular disease) symptomatic or asymptomatic.
- Subjects with terminal status disease or short life expectancy.
- Hypothyroidism without proper control.
- Pregnancy.
- Medical records compiled within a period longer than 3 years to the date of inclusion.
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Cardiovascular Risk Stratification of Ambulatory Patients in Primary Prevention. RISK Study
This is an observational, cross-sectional, national multicenter study, trying to obtain local data about the global cardiovascular risk profile of patients attending ambulatory offices of general practitioners and cardiologists.
The aim of the study is to describe how physicians diagnose and stratify their patients in cardiovascular primary prevention setting and to highlight if patients are stratify through objective tools (risk scores and in this case, wich of them are used) or in subjective ways (clinical evaluation).
Read the detailed description
This is an observational, cross-sectional, national multicenter study, trying to obtain local data about the global cardiovascular risk profile of patients attending ambulatory offices of general practitioners and cardiologists.
The aim of the study is to describe how physicians diagnose and stratify their patients in cardiovascular primary prevention setting and to highlight if patients are stratify through objective tools (risk scores and in this case, wich of them are used) or in subjective ways (clinical evaluation).
- Conditions
- Cardiovascular Primary Prevention
- Keywords
- Cardiovascular primary prevention, Cardiovascular risk strtification
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
| Study group | Role | What they receive |
|---|---|---|
| Target population | This observational, cross-sectional, national multicenter designed study will describe the frequency of use of different evaluation methods (risk scores or subjective assessment) employed to determine the cardiovascular risk of patients in a primary care setting, at both General Practitioners (GPs) or Cardiologists offices. |
What is being measured
The primary outcome is the main question the study is designed to answer.
Desciption of the assessment methods used to define the cardiovascular risk profile of patients attending outpatient medical consultation.
It will be evaluated the cardiovascular risk score for each patient. The proportion of use of each of the validated risk scores, as a tool of individual cardiovascular risk stratification and the proportion of use of a subjective assessment as tools of individual cardiovascular risk stratification used by general practitioners and cardiologists will be described.
Measured: Day 1
Secondary outcomes (4)
Comparison of the subjective individual risk assessment vs. the objective assessment obtained by the WHO risk score.
Comparison of the subjective individual risk assessment performed by the investigator for each patient at the moment of the risk stratification vs. the objective assessment obtained by the WHO risk score.
Measured: Day 1
Comparison of the objective individual risk assessment achieved by the use of any risk score chosen by the treating physician in his / her usual practice vs. the objective assessment obtained by WHO risk score.
Comparison of the objective individual risk assessment achieved by the use of any risk score chosen by the treating physician in his / her usual practice for each patient at the moment of the risk stratification vs. the objective assessment obtained by WHO risk score.
Measured: Day 1
Description of the treatment used, according to risk group and by the specialty of the treating physician.
Description of the pharmacological treatment implemented by the treating physician after risk stratification, according to cardiovascular risk group and by the specialty of the treating physician (cardiologists or GPs), such us Lipid Lowering drugs, antihypertensives, antiplatelet drugs, antidiabetic drugs.
Measured: Day 1
Description of the extent of use of other diagnostic methods to define the individual cardiovascular risk (imaging scans, biomarkers).
Description of use of other diagnostic methods to define the individual cardiovascular risk, such us PCR, Apo A / Apo B, Homocysteine, Neck Vessels Ecodoppler, Echocardiogram, Ca Score, PEG, Ecostress - Gamma camera, etc.
Measured: Day 1
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted28 Jun 2013 (estimated)
- Study startJul 2013
- Primary completionJun 2014
- Study completionJun 2014
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Cardiovascular Primary PreventionStudies of the same condition, open and under way.
- More trials run by AstraZenecaThe sponsor's other registered studies.
- 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
- Time perspective
- Cross-sectional
- Enrolment
- 516 participants (actual)
- Target duration
- 1 Day
Sponsor and investigators
- Lead sponsor
- AstraZeneca
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01889030
- Sponsor's protocol ID
- NIS-CAR-XXX-2013/1
- Acronym
- RISK
- Status last verified
- Jul 2014
- First submitted
- 25 Jun 2013
- Last updated
- 24 Jul 2014
- Results posted
- No
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 24 Jul 2014. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Cardiovascular Risk Stratification of Ambulatory Patients in Primary Prevention. RISK Study
- ClinicalTrials.gov ID
- NCT01889030
- Acronym / sponsor ID
- RISK / NIS-CAR-XXX-2013/1
- Conditions
- Cardiovascular Primary Prevention
- Keywords
- Cardiovascular primary prevention, Cardiovascular risk strtification
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 516 participants (actual)
- Lead sponsor
- AstraZenecaIndustry (pharma, biotech, devices)
- Study start
- Jul 2013
- Primary completion
- Jun 2014 (actual)
- Study completion
- Jun 2014 (actual)
- First posted
- 28 Jun 2013 (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.
This is an observational, cross-sectional, national multicenter study, trying to obtain local data about the global cardiovascular risk profile of patients attending ambulatory offices of general practitioners and cardiologists.
The aim of the study is to describe how physicians diagnose and stratify their patients in cardiovascular primary prevention setting and to highlight if patients are stratify through objective tools (risk scores and in this case, wich of them are used) or in subjective ways (clinical evaluation).
Detailed description
This is an observational, cross-sectional, national multicenter study, trying to obtain local data about the global cardiovascular risk profile of patients attending ambulatory offices of general practitioners and cardiologists.
The aim of the study is to describe how physicians diagnose and stratify their patients in cardiovascular primary prevention setting and to highlight if patients are stratify through objective tools (risk scores and in this case, wich of them are used) or in subjective ways (clinical evaluation).
Study design
- Time perspective
- Cross-sectional
- Target follow-up
- 1 Day
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Target population | – | –This observational, cross-sectional, national multicenter designed study will describe the frequency of use of different evaluation methods (risk scores or subjective assessment) employed to determine the cardiovascular risk of patients in a primary care setting, at both General Practitioners (GPs) or Cardiologists offices. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- Patients older than 18 years old, without known vascular disease (primary prevention) under follow-up by the investigator, whose medical records were initiated during the past 3 years and have completed their baseline assessment of CV risk
Key inclusion criteria (3 listed)
- Patients older than 18 years of age, who give their written consent to take part.
- Patients without known vascular disease (primary prevention) under follow-up by the investigator, whose medical records have been initiated during the last 3 years.
- Patients who have completed their baseline CV risk assessment Lipid lowering treatment naive patients at the time of the stratification.
Key exclusion criteria (6 listed)
- Incomplete or missing medical record data.
- Subjects with prior cardiovascular disease (peripheral vascular disease, coronary or cerebrovascular disease) symptomatic or asymptomatic.
- Subjects with terminal status disease or short life expectancy.
- Hypothyroidism without proper control.
- Pregnancy.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Primary outcome
Desciption of the assessment methods used to define the cardiovascular risk profile of patients attending outpatient medical consultation.
Time frame: Day 1
It will be evaluated the cardiovascular risk score for each patient. The proportion of use of each of the validated risk scores, as a tool of individual cardiovascular risk stratification and the proportion of use of a subjective assessment as tools of individual cardiovascular risk stratification used by general practitioners and cardiologists will be described.
4 secondary outcomes
Comparison of the subjective individual risk assessment vs. the objective assessment obtained by the WHO risk score.
Time frame: Day 1
Comparison of the objective individual risk assessment achieved by the use of any risk score chosen by the treating physician in his / her usual practice vs. the objective assessment obtained by WHO risk score.
Time frame: Day 1
Description of the treatment used, according to risk group and by the specialty of the treating physician.
Time frame: Day 1
Description of the extent of use of other diagnostic methods to define the individual cardiovascular risk (imaging scans, biomarkers).
Time frame: Day 1
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 24 Jul 2014.
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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.
The record lists no contact. Use the official record to reach the sponsor.
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 Primary Prevention, run by AstraZeneca at 1 site in Argentina.
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 3 inclusion and 6 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 24 Jul 2014. 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 Argentina. 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?
Desciption of the assessment methods used to define the cardiovascular risk profile of patients attending outpatient medical consultation. (time frame: Day 1). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
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 24 Jul 2014.