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Completed

NCT Number: NCT01889030

Cardiovascular Risk Stratification of Ambulatory Patients in Primary Prevention

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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Key information

Age range

18 year and older

Sex eligibility

All sexes

Study type

Observational

Primary location

Research Site

Buenos Aires, Argentina

About this 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).

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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.

Treatment and study plan

Primary outcomes

  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 outcomes

  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.

Sponsors and collaborators

Lead sponsor

AstraZeneca

Industry

Registry information

Official study title

Cardiovascular Risk Stratification of Ambulatory Patients in Primary Prevention. RISK Study

Acronym: RISK

Important dates

Study start
2013
Primary completion
2014
Study completion
2014
First posted
Jun 28, 2013
Registry last updated
Jul 24, 2014

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.