Cardiovascular Risk Stratification of Ambulatory Patients in Primary Prevention

Completed

• Conditions: Cardiovascular Primary Prevention

• Registration Number: NCT01889030
• Lead Sponsor: 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).

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 Timeline

• Study First Submitted: 2013-06-25
• Study First Submitted QC: 2013-06-27
• Study First Posted: 2013-06-28
• Study Start: 2013-07
• Primary Completion: 2014-06
• Study Completion: 2014-06
• Status Verified: 2014-07
• Last Update Submitted: 2014-07-23
• Last Update Posted: 2014-07-24

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 516

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 & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
Desciption of the assessment methods used to define the cardiovascular risk profile of patients attending outpatient medical consultation.	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

Name	Time	Method
Comparison of the subjective individual risk assessment vs. the objective assessment obtained by the WHO risk score.	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.
Description of the extent of use of other diagnostic methods to define the individual cardiovascular risk (imaging scans, biomarkers).	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.
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.	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.
Description of the treatment used, according to risk group and by the specialty of the treating physician.	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.

Trial Locations

Locations (1)

Research Site; 🇦🇷 Buenos Aires, Argentina