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

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).

Study Overview

• Status: Completed
• Conditions: 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).

• Study Type: Observational
• Enrollment (Actual): 516

Contacts and Locations

Study Locations

• Argentina
  • Buenos Aires, Argentina
    • Research Site

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

• 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

Description

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.

Study Plan

How is the study designed?

Number of groups / cohorts

1

Cohorts and Interventions

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.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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.	Day 1

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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.	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.	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.	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.	Day 1

Collaborators and Investigators

• Sponsor: AstraZeneca

Study record dates

Study Major Dates

• Study Start: July 1, 2013
• Primary Completion (Actual): June 1, 2014
• Study Completion (Actual): June 1, 2014

Study Registration Dates

• First Submitted: June 25, 2013
• First Submitted That Met QC Criteria: June 27, 2013
• First Posted (Estimate): June 28, 2013

Study Record Updates

• Last Update Posted (Estimate): July 24, 2014
• Last Update Submitted That Met QC Criteria: July 23, 2014
• Last Verified: July 1, 2014

More Information

Terms related to this study

• Keywords: Cardiovascular primary prevention; Cardiovascular risk strtification
• Other Study ID Numbers: NIS-CAR-XXX-2013/1