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Cardiovascular Risk Stratification of Ambulatory Patients in Primary Prevention (RISK)

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ClinicalTrials.gov Identifier: NCT01889030
Recruitment Status : Completed
First Posted : June 28, 2013
Last Update Posted : July 24, 2014
Sponsor:
Information provided by (Responsible Party):
AstraZeneca

Brief 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.

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).


Condition or disease
Cardiovascular Primary Prevention

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).

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Study Type : Observational [Patient Registry]
Actual Enrollment : 516 participants
Time Perspective: Cross-Sectional
Target Follow-Up Duration: 1 Day
Official Title: Cardiovascular Risk Stratification of Ambulatory Patients in Primary Prevention. RISK Study
Study Start Date : July 2013
Actual Primary Completion Date : June 2014
Actual Study Completion Date : June 2014

Group/Cohort
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.



Primary Outcome Measures :
  1. 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.


Secondary Outcome Measures :
  1. Comparison of the subjective individual risk assessment vs. the objective assessment obtained by the WHO risk score. [ Time Frame: Day 1 ]
    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.

  2. 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 ]
    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.

  3. Description of the treatment used, according to risk group and by the specialty of the treating physician. [ Time Frame: Day 1 ]
    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.

  4. Description of the extent of use of other diagnostic methods to define the individual cardiovascular risk (imaging scans, biomarkers). [ Time Frame: Day 1 ]
    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.



Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Sampling Method:   Non-Probability Sample
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
Criteria

Inclusion Criteria:

  • 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.

Exclusion Criteria:

  • 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.

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT01889030


Locations
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Argentina
Research Site
Buenos Aires, Argentina
Sponsors and Collaborators
AstraZeneca
Additional Information:

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Responsible Party: AstraZeneca
ClinicalTrials.gov Identifier: NCT01889030    
Other Study ID Numbers: NIS-CAR-XXX-2013/1
First Posted: June 28, 2013    Key Record Dates
Last Update Posted: July 24, 2014
Last Verified: July 2014
Keywords provided by AstraZeneca:
Cardiovascular primary prevention
Cardiovascular risk strtification